BMJ Open€¦ · percutaneous coronary intervention with drug-eluting stent Journal: BMJ Open...

For peer review only

Long-term follow-up results in patients undergoing percutaneous coronary intervention with drug-eluting stent

Journal: BMJ Open

Manuscript ID: bmjopen-2014-004892

Article Type: Research

Date Submitted by the Author: 20-Jan-2014

Complete List of Authors: Yao, Hai-Mu Wan, You-Dong Zhang, Xiao-Juan Shen, De-Liang Zhang, Jin-Ying Li, Ling Zhao, Luo-Sha Sun, Tong-Wen; the First Affiliated Hospital of Zhengzhou University,

Department of Integrated ICU

<b>Primary Subject Heading</b>:

Cardiovascular medicine

Secondary Subject Heading: Cardiovascular medicine, Surgery

Keywords: Coronary intervention < CARDIOLOGY, Myocardial infarction < CARDIOLOGY, Cardiology < INTERNAL MEDICINE, Clinical trials < THERAPEUTICS

For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml

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Long-term follow-up results in patients undergoing percutaneous

coronary intervention with drug-eluting stent

Hai-Mu Yao1, You-Dong Wan

2, Xiao-Juan Zhang

2, De-Liang Shen

1, Jin-Ying Zhang

1,

Ling Li1, Luo-Sha Zhao

1, Tong-Wen Sun

2

1 Department of Cardiology, the First Affiliated Hospital of Zhengzhou University,

Zhengzhou 450052, PR China

2 Department of Integrated ICU, the First Affiliated Hospital of Zhengzhou University,


Correspondence to: Tong-Wen Sun, MD, PhD, Department of Integrated Intensive

Care Unit, the First Affiliated Hospital, Zhengzhou University, 1 Jianshe East Road,

Zhengzhou 450052, China; telephone number: +86 13838516916, fax number: +86

371 6796 6537, E-mail: [email protected]

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Abstract

Objective: To assess the short and long-term prognosis in consecutive patients with

coronary heart disease (CHD) treated with drug-eluting stent (DES) in one

large-volume PCI center.

Design: Prospective cohort study

Setting: One hospital in Henan province, China, from 2009 to 2011

Participants: 2,735 patients enrolled, patients with ST-elevation myocardial

infarction (STEMI) treated with urgent percutaneous coronary intervention(PCI)

account for 3.9% of cases, patients with STEMI treated with delayed PCI amounted to

20.5%, patients with stable angina (SA) consisted of 16.5% of cases and patients with

non-ST elevation myocardial acute coronary syndromes (NSTE-ACS) constituted

58.6%.

Primary outcome: Major adverse cardiac and cerebrovascular events (MACCEs:

death, myocardial infarction, and stroke) and target vessel revascularization (TVR).

Results: A follow-up after a median of 29.8 months was obtained in 2,533 patients

(92.6%). During the follow-up, death occurred in 7.3% of patients, nonfatal

myocardial infarction in 4.3%, nonfatal stroke in 1.5%, stent thrombosis in 0.7 % and

MACCE in 13.5%. TVR was performed in 4.8%. The highest mortality during the

hospitalization was noted within the urgent PCI group (SA vs. NSTE-ACS vs.

Delayed PCI vs. Urgent PCI, 0.5% vs. 0.5% vs. 1.0% vs. 4.0, respectively, p<0.001).

During follow-up, although the rates of death and MACCE were still higher in the

urgent PCI group, there was no significant difference among different groups.

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Independent predictors of MACCE were: older age (p = 0.007), LVEF＜40% (p =

0.0012), diastolic blood pressure (p = 0.024), multi-vessel disease (p = 0.006), target

vessel = left main stem (p = 0.001).

Conclusions: Long-term follow-up of the DES in clinical practice showed that the

rate of MACCE was comparable to randomized trials, but the rate of TVR was

different in different population. In the real life PCI practice patients with STEMI

have the worst hospital and long-term prognosis.

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Article summary

Article focus

� The study assessed the early and long-term prognosis in consecutive patients with

coronary heart disease treated with drug-eluting stent in one large-volume PCI

center of China.

Key messages

� Percutaneous coronary intervention is of great importance in the proper treatment

of patients with coronary heart disease.

� Drug-eluting stents are currently used to reduce restenosis rates and the need for

target vessel revascularization in a variety of patient subsets.

� The progress which has been made both in medication and interventional

cardiology within the last few years contributes to the gradual improvement of

the results of coronary heart disease therapy.

Strengths and limitations of this study

� This study assessed the early and long-term prognosis in consecutive Chinese

patients at different stage of CHD (stable CHD, acute coronary syndrome)

� The study analyzed the prognosis of patients treated with DES on a more

comprehensive range. The end points included death, myocardial infarction,

stroke, target vessel revascularization, any revascularization, restenosis and stent

thrombosis.

� This is an observational single-center registry study.

Source of Funding: This study was supported by the National Natural Science

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Foundation of China (Grant No. 81370364), Program for Science and Technology

Innovation of Henan Province (NO.201203035), Innovative investigators project

grant from the Health Bureau of Henan Province, Program Grant for Science &

Technology Innovation Talents in Universities of Henan Province (2012HASTIT001),

Henan Provincial Science and Technology Achievement Transformation

Project(122102310581), Henan Province of Medical Scientific Province & Ministry

Research Project(201301005), Henan Province of Medical Scientific Research

Project(201203027),China.

Competing interests None.

Ethics approval The ethics committee of the First Affiliated Hospital of Zhengzhou

University

Provenance and peer review Not commissioned; externally peer reviewed.

Data sharing statement There are no additional data available.

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INTRODUCTION

Coronary Heart Disease (CHD) is one of the greatest challenges of the contemporary

medicine. Myocardial revascularization i.e. percutaneous coronary intervention (PCI)

and coronary artery bypass grafting (CABG) are of great importance in the proper

treatment. Drug-eluting stents (DES) are currently used to reduce restenosis rates and

the need for target vessel revascularization (TVR) in a variety of patient subsets with

significant coronary artery stenoses presenting with either stable angina pectoris or

acute coronary syndromes.

Observational studies1-3

and randomized controlled clinical trials (RCTS)4-9

showed a

marked reduction in restenosis and TVR rates with sirolimus-eluting (SES) and

paclitaxel-eluting stents compared to bare metal stents (BMS). Data from registries,

which reflect the clinical use of DES in a more inhomogeneous daily clinical practice

population, confirmed these finding10-11

. However, data from registries on long-term

follow-up，especially in Chinese population, were sparse. In addition, the progress

which has been made in interventional cardiology within last few years contributes to

the improvement of the results of CHD therapy. Therefore, it is necessary to perform

periodical assessment of the results of treatment.

The aim of the study was the assessment of early and long-term prognosis in all the

patients with CHD treated with DES in one large-volume PCI center of China. The

analysis concerning the safety, effectiveness and long-term follow-up data of the DES

in clinical practice and factors associated with clinical events as well as with the need

for TVR during follow-up.

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METHODS

Study+population

This study was based on consecutive patients who underwent PCI from July 2009 to

August 2011 at a single large-volume PCI center. Only patients treated with at least

one DES and completion of long-term follow-up documentation were included in the

current analysis. Qualitative and quantitative coronary angiographic analyses were

carried out according to standard methods. PCI was performed using standard

techniques. All patients received loading doses of aspirin (300 mg) and clopidogrel

(300 mg) before the coronary intervention, unless they had previously received these

antiplatelet medications. The treatment strategy, stenting techniques, selection of stent

type and use of glycoprotein IIb/IIIa receptor inhibitors or intravascular ultrasound

(IVUS) were all left to the operator’s discretion. After the procedure, aspirin 100mg

was prescribed in addition to clopidogrel 75mg daily, which was prescribed for ≥12

months. Patients were divided into four groups according to the clinical presentation

and the timing of PCI: patients with ST-elevation myocardial infarction (STEMI)

treated with urgent PCI were classified into urgent PCI group, patients with

ST-elevation myocardial infarction (STEMI) treated with delayed PCI were classified

into delayed PCI group, NSTE-ACS group was composed of patients with non-ST

elevation myocardial infarction (NSTEMI) and patients with unstable angina (UA),

and patients with stable angina (SA) were classified into SA group. The study

protocol was approved by the ethics committee of the First Affiliated Hospital of

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Zhengzhou University, and complied with the Declaration of Helsinki.

Definition

Cardiovascular risk factors were assessed at hospital admission and were defined as

follows: Patients ≥ 65 years old were defined as being older age. History of smoking

was assumed if the patients had smoked within the last10 years. Diabetes mellitus

(DM) was defined as an elevated fasting plasma glucose concentration > 6.1 mmol/L

or hemoglobin A1c (HbA1c) > 6.5%, or current treatment with insulin or oral

hypoglycemic agents. Hypertension was defined as systolic blood pressure ≥ 140

mmHg and/or diastolic blood pressure ≥ 90 mmHg, or treatment with

antihypertensive drugs. Dyslipidemia was defined as low-density lipoprotein

cholesterol > 140 mg/dl, high-density lipoprotein < 40 mg/dl, or treatment with

lipid-lowering drugs. Renal insufficiency was defined as a creatinine value ＞ 150

mmol/L, Target vessel revascularization (TVR) was defined as repeat procedure,

either PCI or coronary artery bypass grafting (CABG), in the target vessel. Stent

thrombosis (ST) was either proven by angiography, assumed as probable if an

unexplained sudden death occurred within 30 days after stent implantation or a

Q-wave myocardial infarction was diagnosed in the distribution area of the stented

artery. This classification was issued according to definitions proposed by the

Academic Research Consortium (ARC) 12

.

Clinical+Outcomes and data collection

Data were prospectively entered into a database that contained demographic, clinical,

angiographic and procedural information. Primary end points included all-cause death,

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MI, stent thrombosis and TVR. The composite end points included MACCE

(death/myocardial infarction/stroke). Clinical follow-up was performed through

patients visits, telephone interview and medical record review. Data were entered by

independent research personnel and clinical events were adjudicated by physicians not

involved in the procedures.

Statistics

Distribution of variables was assessed with Kołmogorov-Smirnov test followed by the

t-Student test, ANOVA test or Mann-Whitney test for comparative analysis - the

choice of a test depended on the distribution of a variable. Categorical variables were

expressed as percentages and were analyzed using Chi-square test or Fisher’s Exact

tests. The Kaplan–Meier method was used to calculate follow-up events rates. Cox

proportional hazard analyses were used to identify risk factors for the occurrence of

MACCE and TVR during follow-up. All baseline, demographic, clinical, and

angiographic variables were entered into the model. Results are reported as hazard

ratios (HRs) and 95% confidence intervals (CIs). All statistical tests were 2-tailed, and

p values were statistically significant at ＜ 0.05. All data were analyzed with SPSS

18.0 (SPSS, Inc., Chicago, Illinois)

RESULTS

Between July 2009 and August 2011, 2,735 patients at our hospitals were treated with

at least one DES. A follow-up after a median of 29.8 months (quartiles 25.6–34

months) was obtained in 2,533 patients (92.6 %). The following data are based on

these 2,533 patients. Patients with urgent PCI account for 3.9 % of cases, patients

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with delayed PCI amounted to 20.5 %, patients with stable angina (SA) consisted of

16.5% of cases and patients with NSTE-ACS constituted 58.6%.

Characteristics of the study groups

Initial characteristics of the examined population are presented in Table. 1. The mean

age was 59.9±11.1 years and men constituted 68 % of the examined population. The

left ventricular ejection fraction (LVEF) assessed during hospitalization was 60.9

(±7.45) %. 7.6 % of patients had the history of PCI and CABG amounting to 6.8 %

and 0.8 %, respectively. Patients with STEMI constituted 24.4 %.

The study groups (SA vs. NSTE-ACS vs. Delayed PCI vs. Urgent PCI) were similar

with regard to the heart rate, peripheral vascular disease, heart failure, cerebral

vascular disease and diabetes mellitus (Tab. 1). Patients in urgent PCI group were

younger and most of them were male. Patients in delayed PCI group had the lowest

ejection fraction of the left ventricle. Similarly to the patients with urgent PCI,

patients with delayed PCI had lower systolic blood pressure. Patients with SA were

older and had the highest frequency of atrial fibrillation, past myocardial infarction

and the history of previous revascularization procedures. Similarly to the patients with

SA, patients with urgent PCI had the history of hypertension in 39%, whereas patients

with NSTE-ACS had hypertension in 55% (p<0.000). Patients with delayed PCI had

the highest frequency of dyslipidemia and renal insufficiency. The highest frequency

of current smoker was in the group of urgent PCI.

Angiographic findings and interventional characteristics

Angiographic and interventional characteristics were given in table 2. Left ventricular

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function was normal in 86.8 % of patients and a ≥ 2-vessel disease occurred in 60.6 %

of patients. Most treated lesions were complex with ≥ type B2 according to the AHA

definitions in 62.6 % of cases. The left anterior descending artery was the leading

diseased vessel in 82.6 % of patients. 1.3 % of patients underwent PCI due to

restenosis. 97.5 % of PCI were performed through radial artery access. Coronary

interventions concerned left main stem in 3 % and left descending artery in 71.8 % of

patients, respectively. The average number of arteries subjected to interventions

amounted to 1.52 (±0.67). The average number of stents was 2.16 (±1.26) per person.

There were more complex lesions in NSTE-ACS group and SA group. The study

groups did not differ in the interventional characteristics except for the more frequent

left anterior descending coronary artery intervention within the STEMI group and

more frequent left circumflex coronary artery intervention within the SA group.

In-hospital and follow-up events

In-hospital event rates were low, with a death rate of 0.7 %, a myocardial infarction

rate of 0.6 % and a MACE (death/myocardial infarction) rate of 1.3 % (Table 3). The

highest mortality was noted within the urgent PCI group and the lowest within the SA

group (urgent PCI vs delayed PCI vs NST-ACS vs SA: 4.0 % vs 1.0 % vs 0.5 % vs

0.5 %, respectively, p < 0.001). The highest incidence of MACE was noted within the

urgent PCI group and the lowest within the NSTE-ACS group (urgent PCI vs delayed

PCI vs NST-ACS vs SA: 4.0 % vs 1.8 % vs 1.0 % vs 1.5 %, respectively, p = 0.001).

During the mean follow-up of 29 months, death occurred in 7.3 % of patients,

nonfatal myocardial infarction in 4.3 %, nonfatal stroke in 1.5 %, in-stent restenosis in

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5.7 %, stent thrombosis in 0.7 %, recurrent angina in 11.4 % and MACCE

(death/myocardial infarction/stroke) in 13.5 % (Fig. 1). The rates of death and

MACCE were higher in the urgent PCI group, but there were no significant difference

among groups.

Any revascularization (PCI/CABG) was performed in 7.9 %. Target vessel

revascularization (TVR) was performed in 4.8 %, most of which was PCI (Fig. 2).

The combined MACCE (death/myocardial infarction/stroke) or TVR rate was

18.4 %. The highest frequency of TVR was noted within the SA group and the

lowest within the urgent PCI group.

Single factor analysis proved that older age, urgent PCI, heart failure, atrial

fibrillation, cardiogenic shock, cerebral vascular disease, prior CABG, low density

lipoprotein cholesterol, LVEF ＜ 40%, multi-vessel disease, left main stem lesion

(LM), chronic total occlusion, target vessel = LM, number of stents per patient, length

of stents implanted have contributed to the occurrence of MACCE in long-term

follow-up (Table 4).

Independent predictors of MACCE as determined by Cox proportional hazard

analysis were older age (HR 1.58, 95 % CI 1.13–2.2, p = 0.007), LVEF ＜ 40 %

(HR 1.96, 95 % CI 1.16–3.32, p = 0.012), multi-vessel disease (HR 1.59, 95 % CI

1.14–2.21, p = 0.006), diastolic blood pressure (HR 1.01, 95 % CI 1.0–1.03, p =

0.024), chronic total occlusion (HR 2.26, 95 % CI 1.26–3.49, p = 0.000), and target

vessel = LM (HR 2.89, 95 % CI 1.52–5.52, p = 0.001) (Table 5).

Independent predictors of TVR by either PCI or CABG were prior PCI (HR 3.01,

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95 % CI 1.51–5.98, p = 0.002), number of treated vessel (HR 1.76, 95 % CI 1.27–2.45,

p = 0.001), systolic blood pressure (HR 1.02 95 % CI 1.01–1.03, p = 0.000), total

length of stent implanted (per 10 mm length) (HR 1.23, 95 % CI 1.03–1.62; p =

0.001), LM lesion (HR 3.06, 95 % CI 1.26–7.64, p = 0.016) (Table 6).

DISCUSSION

At present, interventional treatment of patients with CHD is common in China and

worldwide, and its efficacy has been proven in many trials. The amount of patients

treated with PCI increased dramatically in China. Long-term follow-up after

percutaneous coronary interventions is very important: One can detect unforeseen

hazards, such as late and very late stent thrombosis, and is able to determine factors

associated with clinical outcome as well as factors associated with the need for TVR.

Many previously published studies have shown higher mortality in the registries in

comparison to the randomized clinical trials13,14

. Such phenomenon proves a

selectivity of choice of the examined populations in the randomized trials and

contributes to the criticism of some investigators, who warn of the extrapolation of the

results of these studies to the general population of patients with CHD. Different from

randomized controlled trials, registry data reflecting clinical practice give a more

clinically relevant estimate on ‘‘real’’ occurrence rates for clinical as well as TVR

rates.

The presented study is a follow-up study which summarizes a period of

interventional treatment of patients from our center. Our study provide such data:

death occurred in 7.3 % patients, nonfatal myocardial infarction in 4.3 %, nonfatal

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stroke in 1.5 %, in-stent restenosis in 5.7 %, stent thrombosis in 0.7 %, recurrent

angina in 11.4 % and MACCE in 13.5 %. Any TVR rate was performed in 18.4 % of

patients, mainly by PCI.

According to the previous data known from registries, the hospital mortality is

higher in patients with STEMI than in patients with NSTE-ACS (7 % and 5 %,

respectively). However, after 6 months the percentage of deaths is very similar (12 %

vs. 13 %, respectively)15, 16

. The results of the longer follow-up showed that the

percentage of deaths of patients who survived until the end of hospitalization was two

times higher in patients with NSTE-ACS than STEMI 17

. In these studies almost all

the patients with STEMI accepted urgent PCI. In our hospital, however, most of

patients were from countryside. Due to the reasons of health service and traffic, vast

majority of patients with STEMI were first treated at local hospital, and then

transferred to our center for PCI. So in the present study there were only 16 %

patients with STEMI accepted urgent PCI, and the rest accepted delayed PCI. It is

well known that patients with urgent PCI experienced higher morality. Therefore we

assessed the long-term results of the interventional treatment of different groups of

patients with CHD. Moreover, the fast development of interventional techniques and

equipment leading to the improvement of the results of treatment in all groups of

patients with CHD could also lead to the improved prognosis for these patients, hence

we decided to perform the evaluation of the results of treatment in our center.

Controversies concerning justification of interventional treatment in all patients

with stable CHD and different strategies in patients with NSTE-ACS support the

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necessity of performing similar analyses. Hence periodical presentation of the

long-term results of interventional treatment in these groups seems justified. Patients

with SA amounted to 17 % of all population. It is worth remembering that current

recommendations concerning patients with SA, especially after publishing the results

of the COURAGE trial, suggest the relevance of PCI in patients who did not benefit

from previous pharmacological treatment18

. In our study all the patients with SA

presented with clinical symptoms of CHD or had ischemic symptoms in stress tests

(exercise stress test). Patients with SA were older and had higher frequency of atrial

fibrillation, past myocardial infarction and the history of previous revascularization

procedures. The mortality was 0.5 % of hospital cases within the patients with SA,

which proves high efficacy and safety of the interventional treatment. 29-month

mortality accounting for 6.0 % also seems satisfactory.

At present, reduction of mortality is confirmed in patients with STEMI treated with

urgent PCI. In our study, there were 520 patients with STEMI underwent delayed PCI,

and 63 % of them with occluded infarction related artery. It was worthy to note that

current guidelines recommended that delayed PCI of a totally occluded infarct artery

greater than 24 hours after STEMI should not be performed in asymptomatic patients

with 1- or 2-vessel disease if they are hemodynamically and electrically stable and do

not have evidence of severe ischemia19

. Because the data was collected before the

guideline, there was not further classification of different clinical condition. The

mortality both in-hospital and during follow-up was far below compared with urgent

PCI. But the mortality increased markedly during follow-up. Different from previous

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study20

, in which all patients with NSTE-ACS underwent early interventional strategy

after the confirmation of ACS (up to 24 hours of admission). In present study only

patients in high-risk underwent early intervention. Presented results concerning

hospital mortality was 0.5 %. Similar to previous study20

, NSTE-ACS group

presented significant growth of mortality after the hospitalization and it was the

highest of all analyzed populations – from 0.5 % during hospitalization to 7.2%

during a 29-month follow-up. Such results are coherent with the present knowledge

concerning ACS15-17

. This could be associated more complex lesions before PCI

(Table 2). Urgent PCI group had the worst prognosis in both hospital follow-up and a

29-month follow-up. The best prognosis concerned patients with stable angina.

Although the mortality of delayed PCI group during follow-up was lower than urgent

PCI, it increased markedly during follow-up. Higher long-term mortality in patients

with STEMI than in patients with NSTE-ACS observed in our study is not consistent

with previous studies. The highest mortality in patients with STEMI might be the

result of worse systolic function of the left ventricle and the higher frequency of renal

insufficiency in comparison to NSTE-ACS and SA groups during hospitalization. In

present study the mortality both in-hospital and during follow-up was lower than

previous study [20], it might be mainly due to the different proportion of patients who

underwent urgent PCI (3.9 % vs 50 %). It is well known that patients with STEMI

who were treated with urgent PCI experienced higher mortality.

In a recent multi-center registry 11

, the in-hospital mortality, myocardial infarction

rate and MACE (death/myocardial infarction) rate were similar to our data. But

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during the mean follow-up of 4.1 years, death occurred in 9.2 % of patients, nonfatal

myocardial infarction in 5.9 %, nonfatal stroke in 2.2 %, and MACCE

(death/myocardial infarction/stroke) in 16.3 %. Any revascularization (PCI/CABG)

was performed in 34.9 %. Any target vessel revascularization (TVR) was performed

in 20.3 %, being a PCI in 15.7 % and by coronary bypass surgery in 4.6 % of patients.

The clinical events of this study seemed to be higher than our study, especially the

rate of any revascularization (PCI/CABG) and any TVR. This may be explained by

the following reasons: first, patients in this registry were older and had higher

frequency of diabetes mellitus, arterial hypertension, renal insufficiency and the

history of prior myocardial infarction and previous revascularization procedures. In

addition, the proportion of patients presented with STEMI was also higher than our

study. All of these factors were well known risk factor of adverse clinical events.

Second, China is a developing country, due to the reasons of medical care assurance,

and cost, most patients were unwilling to accept another revascularization procedure,

especially CABG. As shown in Table 3, there were 11.4% of patents experienced

recurrent angina, which were just treated with medication and not involved another

revascularization procedure. This might be the main reason of lower rate of any

revascularization (PCI/CABG) and TVR in our study. Of course we can’t exclude the

influence of different ethnic group. In our study the highest frequency of TVR was

noted within the SA group, this could be associated more complex lesions and higher

frequency of the history of previous revascularization procedures before PCI.

There was a big variation regarding to the incidence of ST in previous studies. A

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0.7 % incidence of ST in our study was similar to the 4 main early randomized DES

trials (RAVEL, SIRIUS, C-SIRIUS, and E-SIRIUS) which found 4-year rates of ST

according to the Academic Research Consortium definitions were 0.7% and 0.4%

between DES and BMS when only definite and probable ST were considered21-24

. But

the incidence of ST was much higher in other studies25-26

. ST is a complex

multifactorial syndrome, the individual characteristics of patients, lesions, clinical and

procedural factors are known to contribute to the risk of ST. It is therefore likely that

different baseline clinical and angiographic characteristics explain the diversity in

previous studies. Notably, all of patients in our center were administered dual

antiplatelet therapy at least 12 months, which might partly explain the favorable

clinical outcome of our patients.

Similar to previous study11

, our study showed that older age, reduced left

ventricular function(LVEF＜40%) and Multi-vessel disease were predictors of the

occurrence of MACCE, all of these factors were well known adverse clinical factors

of PCI. Previous studies have identified other clinical variables, such as diabetes,

renal insufficiency, prior myocardial infarction, cardiogenic shock, and angiographic

variables, such as target vessel = bypass graft to predict MACCE. Our study did not

find statistical differences for these variables, but it was limited by the modest number

of events and patients included in each one of these categories, so it has been clearly

underpowered to appropriately assess the role of possible risk factors.

In our study, prior PCI, number of treated vessel, total length of stent implanted

(per 10 mm length) and LM lesion were predictors of the occurrence of TVR.

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Different from previous study11

, target vessel = coronary bypass and ostial lesion were

not predictors of the occurrence of TVR in our study, it might be due to few frequency

of PCI with coronary bypass in our study and different strategy for ostial lesion.

To sum up, it is worth emphasizing that the presented study proves the safety and

effectiveness of DES in everyday practice and brings additional information on the

long-term results of the percutaneous coronary interventions in China.

Study limitation

The presented study is an observational single-center registry and may have the

inherent bias of this type of study. Furthermore, routine angiographic follow-up was

performed in 23.8 % of patients and therefore the rate of restenosis might be lower

than real world condition.

CONCLUSION

These data from a ‘‘real-world’’ registry on the use of DES in 2,533 patients show

during a follow-up of 29 months a MACCE (death, myocardial infarction or stroke)

rate of 13.5 % and a TVR rate of 4.8 %, consisting predominantly of further PCI.

Early and long-term prognosis depends on the form of coronary heart disease. Patients

with STEMI have the worst prognosis and the best to the patients with stable CHD.

The main predictors for the occurrence of MACCE were both clinical parameters and

angiographic parameters, whereas the predictors of TVR were angiographic and

interventional parameters. HMY YDW XJZ DLS JYZ LL LSZ TWS

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Funding: This study was supported by the National Natural Science Foundation of China (Grant

No. 81370364), Program for Science and Technology Innovation of Henan Province

(NO.201203035), Innovative investigators project grant from the Health Bureau of Henan

Province, Program Grant for Science & Technology Innovation Talents in Universities of Henan

Province (2012HASTIT001), Henan Provincial Science and Technology Achievement

Transformation Project(122102310581), Henan Province of Medical Scientific Province &

Ministry Research Project(201301005), Henan Province of Medical Scientific Research

Project(201203027),China.

Contributors HMY participated in the coordination of the study, study design,

provided interpretation of study results and drafted the manuscript. HMY and YDW

and XJZ participated in the study design, performed the analysis and provided

interpretation of study results. DLS and JYZ and LL contributed to the study design

and interpretation of study results. LSZ and TWS contributed to the study design and

provided feedback on the manuscript. TWS conceived of the study, participated in its

design and interpretation, helped draft the manuscript and provided feedback on the

manuscript. All authors read and approved the final manuscript.]

Competing Interests: None

Data Sharing Statement: There are no additional data available

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of 604 patients. Am Heart J 2008; 155:648-53.

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Table 1 General characteristics of the study population.

Urgent PCI

(n=99)

Delayed

PCI

(520)

NSTE-ACS

(1496)

SA

(n=418)

Total

（（（（n=2533））））

P value

Age(years) 58±12.6 57.9±11.5 60.5±10.8 61±10.9 59.9±11.1 0.000

Older age, n(%) 33(33.3) 159(33.6) 576(38.5) 171(40.8) 937(30.7) 0.003

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Male gender, n(%) 79(80.6) 397(76.2) 948(63.3) 301(71.8) 1723(68) 0.000

BMI(kg/m2) 22.5±3.95 22.9±4.03 24.3±3.6 24.1±3.6 23.9±3.8 0.000

HR(beats/min) 73.6±15.7 72.1±12.1 72.1±11.3 72.2±11.5 72.2±11.7 0.715

Systolic BP(mmHg) 98.9±26.7 99.2±28.5 103.6±28.4 109.4±30.2 103.3±28.8 0.000

Diastolic BP(mmHg) 76.8±13.9 76.6±12.6 77.0±11.6 78.9±12.3 77.2±12.0 0.109

Prior PCI, n(%) 3(3) 13(2.5) 116(7.8) 40(9.5) 172(6.8) 0.000

Prior CABG, n(%) 0(0) 0(0) 18(1.2) 3(0.7) 21(0.8) 0.05

OMI, n(%) 2(2) 14(2.7) 70(4.7) 149(35.6) 235(9.3) 0.000

PVD, n(%) 0(0) 1(0.2) 2(0.1) 3(0.7) 6(0.2) 0.169

LVEF, (mean ± SD) 59.2±6.63 57.4±8.14 62.5±6.38 59.4±8.58 60.9±7.45 0.000

HF(NYHA Ⅲ/Ⅳ), n(%) 12(12.2) 60(11.5) 187(12.5) 36(8.6) 295(11.7) 0.183

CVD, n(%) 7(7.1) 27(5.2) 73(4.9) 28(6.7) 135(5.3) 0.43

Atrial fibrillation, n(%) 0(0) 5(1) 19(1.3) 2.6(6.2) 50(2) 0.000

Risk factors, n(%)

Hypertension 39(39.4) 217(41.7) 826(55.2) 164(39.2) 1249(49.2) 0.000

Diabetes mellitus 23(23.2) 104(20) 322(21.6) 72(17.3) 521(20.6) 0.234

Dyslipidemia 57(58.3) 321(61.8) 800(53.5) 201(48.1) 1379(54.4) 0.000

Current smoker 38(38.4) 180(34.5) 373(25) 80(19.1) 671(26.5) 0.000

Renal insufficiency 0(0)) 12(2.3) 13(0.9) 3(0.7) 28(1.1) 0.026

Clinical presentation

Stable angina 418(16.5)

Unstable angina 1496(59)

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Non-STEMI 2(2.0) 25(4.8) 0(0) 0(0) 27(1.1)

STMI 99(3.9) 520(20.5) 619(24.4)

Presence of shock, n(%) 3(3) 1(1.2) 0(0) 0(0) 4(0.2) 0.000

TC(mmol/L) 4.47±0.99 4.13±0.12 4.31±1.08 4.18±1.05 4.26±1.06 0.92

TG(mmol/L) 1.73±0.89 1.78±1.04 1.99±1.48 1.81±1.1 1.91±135 0.162

LDL-C(mmol/L) 2.99±0.99 2.59±0.87 2.7±0.95 2.59±0.91 2.67±0.94 0.177

HDL-C(mmol/L) 1.04±0.26 0.99±0.29 1.09±0.33 1.05±0.31 1.06±0.32 0.001

Glycemia(mmol/L) 7.97±3.5 6.61±5.17 5.78±2.14 5.8±2.15 6.05±3.15 0.000

Medication at discharge

Aspirin, n(%) 97(98) 516(99.2) 1476(98.7) 409(98.1) 2498(98.7) 0.426

Clopidogrel, n(%) 98(99) 518(99.6) 1486(98.9) 416(99.5) 2518(99.4) 0.87

ACEI/ARB, n(%) 48(48.5) 335(64.3) 780(52.2) 191(45.8) 1354(53.5) 0.000

Beta-blocker, n(%) 52(52.5) 384(73.7) 1057(70.7) 227(54.3) 1720(67.9) 0.000

Statins, n(%) 91(91.9) 487(93.5) 1399(93.6) 408(97.6) 2358(94.2) 0.625

BMI: body mass index, HR: heart rate, PCI: percutaneous coronary intervention, CABG: coronary artery bypass

graft, OMI: old myocardial infarction, PVD: peripheral vascular disease, LVEF: left ventricular ejection fraction,

HF: heart failure, CVD: cerebral vascular disease, Non-STEMI: Non-ST-elevation myocardial infarction, STEMI:

ST-elevation myocardial infarction, TC: total cholesterol, TG: triglyceride, LDL-C: low density lipidprotein

cholesterol, HDL-C: high density lipidprotein cholesterol, ACEI/ARB: angiotensin-converting enzyme inhibitors

or angiotensin recptor blocker

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Table 2 Angiographic finds and interventional characteristic.

Urgent PCI

(n=99)

Delayed PCI

(520)

NSTE-ACS

(1496)

SA

(n=418)

Total

（（（（n=2533））））

P value

Radial artery accessa 97(98) 511(98.1) 1458(97.5) 403(96.4) 2469(97.5) 0.421

Number of diseased vesselsa

1-vessel disease 37(37.4) 196(37.6) 614(41.1) 143(34.2) 990(39.1) 0.065

2-vessel disease 42(42.4) 197(37.8) 528(35.3) 162(38.8) 929(36.7) 0.3

3-vessel disease 20(20.2) 128(24.6) 348(23.3) 110(26.3) 606(23.9) 0.47

Location of lesiona

Left main stem 3(3) 14(2.7) 55(3.7) 14(3.3) 85(3.4) 0.237

LAD 84(84.8) 460(90.3) 1188(79.4) 360(86.1) 2092(82.6) 0.000

LCX 47(46.5) 241(46.3) 725(48.5) 211(50.4) 1224(48.3) 0.86

RCA 53(53.5) 258(49.5) 731(48.9) 215(51.5) 1257(49.6) 0.688

LVEFa(n=1600)

＞55% 29 (82.9) 243 (71.1) 920 (93.5) 197 (82.4) 1389 (86.8) 0.000

41-55% 6 (17.1) 89 (26) 52 (5.3) 27 (11.3) 174 (10.9) 0.000

≤40% 0(0) 10 (2.9) 12 (1.2) 15 (6.3) 37 (2.3) 0.000

Type of target lesion

according to AHA/ACCa

(n=4712)

A 19(10.1) 85(8.6) 250(9.2) 67(8.2) 421(8.9) 0.755

B1 70(37.2) 308(31.2) 756(27.8) 209(25.6) 1343(28.5) 0.002

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B2 53(28.2) 318(32.3) 1031(37.9) 297(36.4) 1699(36.1) 0.002

C 46(24.5) 275(27.9) 683(28.1) 243(29.7) 1247(26.5) 0.036

Total chronic occlusionsa 9(9.1) 35(6.7) 135(90 47(11.2) 226(8.9) 0.116

Ostial lesionsa 8(8.1) 64(12.3) 154(10.3) 49(11.7) 275(10.9) 0.443

Restenotic lesionsa 1(10) 4(0.8) 21(1.4) 8(1.9) 34(1.3) 0.483

Number of treated vesselsb 1.36±0.59 1.55±0.67 1.5±0.66 1.57±0.7 1.52±0.67 0.12

Location of target lesions a

Left main stem 1(1) 15(2.9) 45(3) 14(3.3) 75(3) 0.67

LAD 63(63.6) 405(77.7) 1037(69.4) 314(75.1) 1819(71.8) 0.000

LCX 28(28.3) 175(33.6) 573(38.3) 164(39.2) 940(37.1) 0.05

RCA 43(43.4) 216(41.5) 596(39.9) 167(40) 1022(40.3) 0.842

Coronary bypass graft 0(0) 0(0) 3(0.2) 1(0.2) 4(0.2) 0.722

NO. of stents per patientb 2.04±1.43 2.21±1.23 2.12±1.24 2.26+1.3 2.16±1.26 0.452

Total stent length per

patientb

45.5±29.1 51.9±32.1 48.9±32.4 53.4±34.6 50.1±32.6 0.267

Stent Diameter (mm)b 3.11±0.45 3.07±0.42 3.08±0.44 3.05±0.42 3.07±0.43 0.363

LAD: left anterior descending artery, LCX: left circumflex artery, RCA: right coronary artery, LVEF: left

ventricular ejection fraction

a: n(%), b: mean ± SD

Table 3 Clinical events from PCI until discharge and end of follow up

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Urgent PCI

(n=99)

Delayed PCI

(520)

NSTE-ACS

(1496)

SA

(n=418)

Total

（（（（n=2533））））

P value

In-hospital events(%)

Death 4.0 1.0 0.5 0.5 0.7 <0.001

Any MI 0 0.8 0.5 1.0 0.6 0.635

MACE 4.0 1.8 1.0 1.5 1.3 0.001

Follow-up(cumulated events)

(%)

Death 12.1 7.7 7.2 6.0 7.3 0.104

Nonfatal MI 6.0 4.6 4.4 2.9 4.3 0.414

Nonfatal stroke 2.0 1.7 1.1 2.4 1.5 0.267

MACCE 21.2 13.3 13.6 11.7 13.5 0.069

Any revascularization

(PCI/CABG)

6.1 6.9 8.4 7.9 7.9 0.632

TVR 2.0 2.9 5.3 6.2 4.8 0.037

MACCE or TVR 23.2 16.2 18.9 18.2 18.4 0.223

In-stent restenosis 5.1 3.3 6.6 6.0 5.7 0.048

Angiographic follow up 21.2 19.2 24.5 27.5 23.8 0.018

Stent thrombosis

(definite/probable)

1.0 0.8 0.6 1.0 0.7 0.859

Recurrent angina 13.1 10.6 11.6 11.5 11.4 0.872

MACE: death/myocardial infarction, MI: myocardial infarction, MACCE: death/myocardial/stroke, TVR: target

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vessel revascularization, PCI: percutaneous coronary intervention, CABG-coronary bypass grafting

Table 4 Univariate Analysis of predictors of the occurrence of MACCE

HR 95%CI P value

Older age 1.55 1.23-1.97 0.000

Urgent PCI 1.93 1.21-3.08 0.006

Heart failure 1.75 1.28-2.38 0.000

Atrial fibrillation 2.2 1.2-4.0 0.01

Cardiogenic shock 16.79 5.36-52.5 0.000

Cerebral vascular disease 1.68 1.09-2.57 0.017

Prior CABG 2.46 1.02-5.97 0.046

LDL-C 1.15 1.01-1.3 0.039

LVEF＜40% 1.4 1.04-1.89 0.028

Multi-vessel disease 1.7 1.33-2.18 0.000

Left main stem lesion 1.3 0.55-3.38 0.51

Chronic total occlusion 2.18 1.58-2.99 0.000

Target vessel=LM 2.23 1.34-3.69 0.002

Target vessel=LAD 0.749 0.58-0.96 0.024

NO. of stents per patient 1.004 1-1.007 0.033

Length of stents implanted 3.09 2.11-4.52 0.000

Stent Diameter (mm) 0.6 0.45-0.81 0.001

PCI: percutaneous coronary intervention, CABG-coronary bypass grafting, LDL-C: low density lipoprotein

cholesterol, LVEF: left ventricular ejection fraction,LM: left main stem, LAD: left anterior descending artery.

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Table 5 Multivariate analysis of predictor of the occurrence of MACCE

Wald’s Chi square HR(95%CI) P value

Older age 7.15 1.58(1.13-2.2) 0.007

LVEF＜40% 6.31 1.96(1.16-3.32) 0.012

Multi-vessel disease 5.55 1.59(1.14-2.21) 0.006

Diastolic blood pressure 5.07 1.01(1.0-1.03) 0.024

Chronic total occlusion 13.56 2.26(1.46-3.49) 0.000

Target vessel=LM 10.39 2.89(1.52-5.52) 0.001

LVEF: left ventricular ejection fraction, LM: left main stem

Table 6 Multivariate analysis of predictors of the occurrence of TVR

Wald’s Chi square HR(95%CI) P value

Prior PCI 9.84 3.01(1.51-5.98) 0.002

Number of treated vessel 11.61 1.76(1.27-2.45) 0.001

total length of stent

implanted (per 10 mm

1.23 1.23(1.03-1.62) 0.001

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length)

LM lesion 5.78 3.06(1.23-7.64) 0.016

LM: left main stem, PCI: percutaneous coronary intervention

Figure legends

Fig 1. Kaplan-Meier curve for MACCE during follow-up. MACCE: major adverse

cardiovascular or cerebral events.

Fig 2. Kaplan-Meier curve for TVR during follow-up. TVR: target vessel

revascularization.

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Figure 1. Kaplan-Meier curve for MACCE during follow-up. MACCE: major adverse cardiovascular or cerebral events.

133x133mm (300 x 300 DPI)

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Figure 2. Kaplan-Meier curve for TVR during follow-up. TVR: target vessel revascularization. 132x133mm (300 x 300 DPI)

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STROBE 2007 (v4) Statement—Checklist of items that should be included in reports of cohort studies

Section/Topic Item

# Recommendation Reported on page #

Title and abstract 1 (a) Indicate the study’s design with a commonly used term in the title or the abstract 1

(b) Provide in the abstract an informative and balanced summary of what was done and what was found 2

Introduction

Background/rationale 2 Explain the scientific background and rationale for the investigation being reported 6

Objectives 3 State specific objectives, including any prespecified hypotheses 6

Methods

Study design 4 Present key elements of study design early in the paper 7

Setting 5 Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data

collection

7

Participants 6 (a) Give the eligibility criteria, and the sources and methods of selection of participants. Describe methods of follow-up 7

(b) For matched studies, give matching criteria and number of exposed and unexposed 7

Variables 7 Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if

applicable

7

Data sources/

measurement

8* For each variable of interest, give sources of data and details of methods of assessment (measurement). Describe

comparability of assessment methods if there is more than one group

7

Bias 9 Describe any efforts to address potential sources of bias 8

Study size 10 Explain how the study size was arrived at 7

Quantitative variables 11 Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen and

why

8

Statistical methods 12 (a) Describe all statistical methods, including those used to control for confounding 9

(b) Describe any methods used to examine subgroups and interactions 9

(c) Explain how missing data were addressed 9

(d) If applicable, explain how loss to follow-up was addressed 9

(e) Describe any sensitivity analyses 9

Results

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Participants 13* (a) Report numbers of individuals at each stage of study—eg numbers potentially eligible, examined for eligibility, confirmed

eligible, included in the study, completing follow-up, and analysed

9

(b) Give reasons for non-participation at each stage 9

(c) Consider use of a flow diagram 10

Descriptive data 14* (a) Give characteristics of study participants (eg demographic, clinical, social) and information on exposures and potential

confounders

10

(b) Indicate number of participants with missing data for each variable of interest 10

(c) Summarise follow-up time (eg, average and total amount) 10

Outcome data 15* Report numbers of outcome events or summary measures over time 10

Main results 16 (a) Give unadjusted estimates and, if applicable, confounder-adjusted estimates and their precision (eg, 95% confidence

interval). Make clear which confounders were adjusted for and why they were included

11

(b) Report category boundaries when continuous variables were categorized 11

(c) If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period 11

Other analyses 17 Report other analyses done—eg analyses of subgroups and interactions, and sensitivity analyses 12

Discussion

Key results 18 Summarise key results with reference to study objectives 13

Limitations 19

Interpretation 20 Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results from

similar studies, and other relevant evidence

19

Generalisability 21 Discuss the generalisability (external validity) of the study results 19

Other information

Funding 22 Give the source of funding and the role of the funders for the present study and, if applicable, for the original study on

which the present article is based

3

*Give information separately for cases and controls in case-control studies and, if applicable, for exposed and unexposed groups in cohort and cross-sectional studies.

Note: An Explanation and Elaboration article discusses each checklist item and gives methodological background and published examples of transparent reporting. The STROBE

checklist is best used in conjunction with this article (freely available on the Web sites of PLoS Medicine at http://www.plosmedicine.org/, Annals of Internal Medicine at

http://www.annals.org/, and Epidemiology at http://www.epidem.com/). Information on the STROBE Initiative is available at www.strobe-statement.org.

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Long-term follow-up results in patients undergoing percutaneous coronary intervention with drug-eluting

stents:results from a single large-volume PCI center

Journal: BMJ Open

Manuscript ID: bmjopen-2014-004892.R1


Date Submitted by the Author: 17-Apr-2014

Complete List of Authors: Yao, Hai-Mu; the First Affiliated Hospital of Zhengzhou University, Department of Cardiology Wan, You-Dong; the First Affiliated Hospital of Zhengzhou University,

Department of Integrated ICU Zhang, Xiao-Juan; the First Affiliated Hospital of Zhengzhou University, Department of Integrated ICU Shen, De-Liang; the First Affiliated Hospital of Zhengzhou University, Department of Cardiology Zhang, Jin-Ying; the First Affiliated Hospital of Zhengzhou University, Department of Cardiology Li, Ling; the First Affiliated Hospital of Zhengzhou University, Department of Cardiology Zhao, Luo-Sha; the First Affiliated Hospital of Zhengzhou University, Department of Cardiology Sun, Tong-Wen; the First Affiliated Hospital of Zhengzhou University,

Department of Integrated ICU




Keywords: Coronary intervention < CARDIOLOGY, Myocardial infarction < CARDIOLOGY, Cardiology < INTERNAL MEDICINE, Clinical trials < THERAPEUTICS


BMJ Open on M


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1


coronary intervention with drug-eluting stents：：：：results from a single

large-volume PCI center


2, Xiao-Juan Zhang

2, De-Liang Shen

1, Jin-Ying Zhang

1,


1, Tong-Wen Sun

2

1Department of Cardiology, the First Affiliated Hospital of Zhengzhou University,


2Department of Integrated ICU, the First Affiliated Hospital of Zhengzhou University,




Zhengzhou 450052, China, Tel: +86 138 3851 6916, Fax: +86 371 6796 6537, E-mail:

[email protected]

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Abstract

Objective: To assess both short and long-term prognosis in consecutive patients with

coronary heart disease (CHD) treated with drug-eluting stents (DES) in a

large-volume percutaneous coronary intervention (PCI) center.

Design: Observational cohort study

Setting: A hospital in the Henan province, China, between 2009 and 2011.

Participants: A total of 2,533 patients were enrolled. Patients with ST-elevation

myocardial infarction (STEMI) treated with urgent PCI accounted for 3.9% of cases;

patients with STEMI treated with delayed PCI accounted for 20.5% of cases; patients

with stable angina (SA) accounted for 16.5% of cases; and patients with non-ST

elevation acute coronary syndromes (NSTE-ACS) accounted for 58.6% of cases.

Primary outcomes: Death, major adverse cardiac and cerebrovascular events

(MACCE: death/ myocardial infarction/ stroke), and target vessel revascularization

(TVR).

Results: Follow-up after a median of 29.8 months was obtained for 2,533 patients

(92.6%). The highest mortality rate during hospitalization was noted within the urgent

PCI group (p <0.001). During follow-up, although death and MACCE were higher in

the urgent PCI group, no significant differences were observed between the different

groups. The incidence of cardiac death and myocardial infarction (MI) was

significantly higher in the paclitaxel-eluting stents (PES) group than in the

sirolimus-eluting stents (SES) group. Independent predictors of death during

follow-up were: age, left ventricular ejection function (LVEF) < 40%, diabetes

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mellitus, prior coronary artery bypass grafting (CABG), and chronic total occlusion.

Conclusions: PCI patients with STEMI had the worst hospital and long-term

prognosis. The highest relative increase of mortality after discharge for patients with

CHD undergoing PCI were seen in NSTE-ACS patients；SES seem to be more

effective than PES.

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Article summary

Article focus

� The study assessed both early and long-term prognosis in consecutive patients

with coronary heart disease (CHD) treated with drug-eluting stents (DES) at a

large-volume percutaneous coronary intervention (PCI) center in China.

Key messages

� PCI is critical for patients with CHD.

� DES are currently used to reduce restenosis rates and for target vessel

revascularization (TVR) in a variety of patient subsets.

� Recent developments in drugs and interventional cardiology have contributed to a

gradual improvement in CHD therapy.


� This study assessed early and long-term prognosis in consecutive Chinese

patients at different stages of CHD (stable CHD, acute coronary syndrome)

� The study analyzed the prognosis of a comprehensive range of patients treated

with DES. The end points included death, myocardial infarction (MI), stroke,

TVR, any revascularization, in-stent restenosis, and stent thrombosis.


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INTRODUCTION

Coronary heart disease (CHD) is one of the greatest challenges of contemporary

medicine. Myocardial revascularization，i.e. percutaneous coronary intervention (PCI)


treatment of CHD. Drug-eluting stents (DES) are currently used to reduce restenosis

rates and the need for target vessel revascularization (TVR) in a variety of patients

with significant coronary artery stenosis presenting with either stable angina (SA)

pectoris or acute coronary syndromes.


and randomized controlled clinical trials (RCTS)4 -9

have

shown a marked reduction in restenosis and TVR rates with sirolimus-eluting stents

(SES) and paclitaxel-eluting stents (PES) compared to bare metal stents (BMS). Data

from registries, which reflect the clinical use of DES in a more inhomogeneous daily

clinical practice population, have confirmed these findings10-11

; however, data from

registries on long-term follow-up，especially in the Chinese population, were sparse.

In addition, advances in interventional cardiology within the last few years have

contributed to the improvement of CHD therapy results; thus it is necessary to

perform a periodical assessment of the treatments. The aim of this study was to assess

both the early and long-term prognosis in all patients with CHD treated with DES in a

large-volume PCI center in China.

METHODS

Study�population

The study was carried out on consecutively enrolled patients who underwent PCI

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between July 2009 and August 2011, at a single large-volume PCI center. Only

patients treated with at least one DES, and who completed long-term follow-up

documentation, were recruited for the study. Qualitative and quantitative coronary

angiographic analyses were carried out according to standard methods. PCI was

performed using standard techniques. All patients were given loading doses of aspirin

(300 mg) and clopidogrel (300 mg) before coronary intervention, unless they had

already received antiplatelet medication. The treatment strategy, stenting techniques,

selection of stent type, and use of glycoprotein IIb/IIIa receptor inhibitors or

intravascular ultrasound (IVUS) were all left to the operator’s discretion. All patients

were prescribed 100 mg/d aspirin indefinitely and clopidogrel 75 mg/d for at least the

first 12 months after the procedure. Patients were divided into four groups according

to their clinical presentation and timing of PCI, as follows: patients with ST elevation


patients with STEMI treated with delayed PCI (delayed PCI) accounted for 20.5% of

cases; patients with SA accounted for 16.5% of cases; and patients with NSTE-ACS

accounted for 58.6% of cases. The NSTE-ACS group consisted of patients with

non-ST elevation myocardial infarction (NSTEMI) and patients with unstable angina

(UA). The study protocol was approved by the ethics committee of the First Affiliated

Hospital of Zhengzhou University, and complied with the Declaration of Helsinki.

Definitions used in the study

Cardiovascular risk factors were assessed at the time of hospital admission.

Patients were considered as having a history of smoking if they had smoked within

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the last 10 years. Patients were classed as having diabetes mellitus if their fasting

plasma glucose concentration was > 6.1 mmol/L or their hemoglobin A1c (HbA1c)

was > 6.5%, or if they were currently being treated with insulin or oral hypoglycemic

agents. Patients were defined as having hypertension if their systolic blood pressure ≥

140 mmHg, their diastolic blood pressure was ≥ 90 mmHg, or if antihypertensive

drugs were prescribed. Patients were diagnosed with dyslipidemia if low-density

lipoprotein cholesterol was > 140 mg/dL, high-density lipoprotein was < 40 mg/dL, or

if lipid-lowering drugs were prescribed. Renal insufficiency was defined if the

creatinine value was >150 mmol/L. TVR was defined as a repeat procedure, either

PCI or CABG, in the target vessel. Stent thrombosis (ST) was either proven by

angiography or assumed as probable if an unexplained sudden death occurred within

30 days after stent implantation or if a Q-wave myocardial infarction (MI) was

diagnosed in the distribution area of the stented artery. This classification was issued

according to definitions proposed by the Academic Research Consortium (ARC) 12

.

Clinical�outcomes and data collection

Prospective data were entered into a database that contained demographic,

clinical, angiographic, and procedural information. Primary end points included

all-cause mortality, occurrence of MI, stent thrombosis, and TVR. The composite end

points were defined as major adverse cardiac and cerebrovascular events (MACCE),

namely death, MI, and stroke. Clinical follow-up was carried out through patient

visits, telephone interviews, and medical record reviews. Independent research

personnel entered the data and an independent committee adjudicated clinical events.

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at least one DES. Follow-up after a median of 29.8 months (quartiles 25.6–34 months)

was carried out on 2,533 patients (92.6%).

Statistics

Distribution of variables was assessed using the Kołmogorov-Smirnov test

followed by the Student-t test, ANOVA test, or Mann-Whitney test for comparative

analysis; the choice of test depended on the distribution of variables. Categorical

variables were expressed as percentages and were analyzed using the Chi-square test

or Fisher’s exact tests. Cox proportional hazards analyses were used to identify risk

factors for the occurrence of MACCE and TVR during follow-up. All baseline,

demographic, clinical, and angiographic variables were entered into the model.

Results are reported as hazard ratios (HRs) and 95% confidence intervals (CIs). All

statistical tests were 2-tailed, and p-values were statistically significant at < 0.05. All

data were analyzed using SPSS 18.0 software (SPSS, Inc., Chicago, Illinois, USA).

RESULTS


Demographic characteristics of the 2,533 patients enrolled in the study are shown

in Table 1. The mean age was 59.9 ± 11.1 years and 68% of patients were male.

Patients in the urgent PCI group were younger and predominantly male. Patients in

the delayed PCI group had the lowest left ventricular ejection fraction. Patients with

SA were older and had the highest frequency of past MI and a history of previous

revascularization procedures. The percentage of patients with a history of

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hypertension was significantly higher in the NSTE-ACS group than in the other

groups (p <0.001). Patients with delayed PCI had the highest frequency of

dyslipidemia and renal insufficiency.

<Table 1 near here>


The most complex lesions were found in the NSTE-ACS and SA groups. The

study groups did not differ in interventional characteristics except for a higher

frequency of left anterior descending coronary artery intervention within the STEMI

group, and a higher frequency of left circumflex coronary artery intervention within

the SA group (Table 2).

<Table 2 near here>


In-hospital event rates were low. The highest mortality rate was noted within the

urgent PCI group and the lowest rate was observed within the SA group (p < 0.001).

The highest incidence of MACE was noted within the urgent PCI group and the

lowest incidence of MACE was noted within the NSTE-ACS group (p = 0.001).

During the mean follow-up of 29 months, the incidence of death and MACCE were

higher in the urgent PCI group, but no significant differences were observed between

the groups. The highest frequency of TVR was noted within the SA group and the

lowest frequency was noted within the urgent PCI group (p = 0.001). The highest

frequency of in-stent restenosis was noted within the NSTE-ACS group and the

lowest frequency was noted within the delayed PCI group (p = 0.048) (Table 3).

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<Table 3 near here>

To estimate the effect of different DES on clinical outcomes, we conducted a

subanalysis. Out of a total of 1,650 patients treated with SES, 504 patients were

treated with PES and 379 patients were treated with a mixture of different types of

DES. The baseline and procedural characteristics according to SES and PES are

shown in Table 4. Significant differences between the two groups were observed in

the number of treated vessels, the number of stents per patient, total stent length per

patient, and stent diameter. During follow-up, the incidence of cardiac death and MI

was significantly higher in the PES group than in the SES group，and although the

incidence of TVR was also higher in the PES group, this was not statistically

significant (P >0.05) (Table 5).

<Tables 4 and 5 near here>

According to the Cox proportional hazards analysis, age, left ventricular ejection

fraction (LVEF) < 40%, prior CABG, diabetes mellitus, and chronic total occlusion

were identified as independent predictors of death; while age, LVEF < 40 %,

multi-vessel disease, diastolic blood pressure, chronic total occlusion, and target

vessel = left main (LM) were identified as independent predictors of MACCE. By

contrast, independent predictors of TVR were prior PCI, number of treated vessels,

total length of implanted stents (per 10 mm length), and LM lesions (Table 6).

<Table 6 near here>

DISCUSSION

At present, interventional treatment for patients with CHD is common in China and

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throughout the world, and its efficacy has been proven in many trials. Numerous

studies have shown higher mortality rate in registries than in randomized clinical

trials13,14

, which prove the selectivity of choice of examined populations in

randomized trials. Registry data reflecting clinical practice gives a more clinically

relevant estimate of ‘‘real’’ occurrence rates for clinical as well as TVR rates than data

from randomized controlled trials.

The present study is a follow-up study of patients receiving interventional

treatments at our center over a defined period of time, and from the data we gather the

following information: death occurred in 7.3% of patients, the incidence of MACCE

in 13.5%, the rate of stent thrombosis in 0.7%, and the incidence of TVR was 4.8%.

The highest incidence of in-hospital mortality and MACE was noted within the urgent

PCI group. During follow-up, the highest frequency of TVR was noted within the SA

group, and the highest frequency of in-stent restenosis was noted within the

NSTE-ACS group. The incidence of cardiac death and MI were significantly higher in

the PES group than in the SES group.

According to previous data from other registries, the rate of hospital mortality is

higher in patients with STEMI than in patients with NSTE-ACS (7% and 5%,

respectively). However, after six months the mortality rate is very similar (12% vs.

13%, respectively)15, 16

. The results of the longer follow-up showed that the mortality

rates for patients who survived until the end of hospitalization was two times higher in

patients with NSTE-ACS than in patients with STEMI17

. In these studies, almost all

patients with STEMI received urgent PCI; however, in our hospital, because most

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patients came from the countryside, the majority of those with STEMI were first

treated at a local hospital and then transferred to our center for PCI. Therefore only

16% of patients with STEMI received urgent PCI, and the rest received delayed PCI.

It is well known that patients with urgent PCI experience higher morality rates, so,

because of this, we assessed the long-term results of the interventional treatment on

different groups of patients with CHD.

Controversy over the justification of interventional treatments in all patients with

stable CHD and the different strategies for patients with NSTE-ACS, underlines the

need to perform similar analyses. In the present study, patients with SA accounted for

17% of the total population. It is worth remembering that current guidelines for

patients with SA, particularly after publication of the COURAGE trial, suggest the

relevance of PCI in patients who did not benefit from previous pharmacological

treatment18

. In our study, patients with SA were older and had a higher frequency of

past MI as well as a history of previous revascularization procedures. The in-hospital

mortality rate for patients with SA was 0.5%, which proves the high efficacy and

safety of the interventional treatment; the 6% mortality rate observed at the 29 month

follow-up was also low.

At present, a reduction in mortality rates is confirmed in patients with STEMI

treated with urgent PCI. In our study, 520 patients with STEMI received delayed PCI,

and 63% of them had occluded infarction related arteries. It is worth noting that

current guidelines recommend not performing delayed PCI on a totally occluded

infarct artery 24 hours after STEMI, in asymptomatic patients with 1- or 2-vessel

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disease if they are hemodynamically and electrically stable and show no evidence of

severe ischemia19

. Because our data was collected before this guideline was published,

it was not further classified into different clinical conditions. Death observed both

in-hospital and during follow-up were far fewer than for urgent PCI; however,

mortality rates markedly increased during the follow-up. In contrast to a previously

published study20

, where all patients with NSTE-ACS received early interventional

treatment after confirming ACS (within 24 hours of admission), in the present study

only high-risk patients received early intervention. Similar to a previous study20

, the

NSTE-ACS group showed a significant increase in mortality after hospitalization,

which was the highest of all analyzed populations: from 0.5% during hospitalization

to 7.2% during the 29 month follow-up. These results are in line with current

knowledge on acute coronary syndrome (ACS)15-17

, and could be associated with

more complex lesions before PCI (Table 2). Although mortality in the delayed PCI

was lower than in the urgent PCI group, it increased markedly during follow-up. The

higher long-term mortality in patients with STEMI compared to patients with

NSTE-ACS observed in our study is not consistent with previous studies, and might

be the result of worse systolic function of the left ventricle and a higher frequency of

renal insufficiency compared to the NSTE-ACS and SA groups. In the present study,

both in-hospital and follow-up mortality rates were lower than those reported in

previous study20

, which is mainly due to the different proportion of patients who

underwent urgent PCI (3.9% vs. 50%). It is well known that patients with STEMI

who are treated with urgent PCI experience higher mortality rates.

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In a recent multi-center registry11

, in-hospital mortality, MI and MACE

(death/myocardial infarction) rates were similar to those observed in our study.

However, during a mean follow-up of 4.1 years, clinical events in the multi-center

registry were higher than in our study, especially the rate of any revascularization

(PCI/CABG) and TVR. There are several possible explanations for this. First, patients

in this registry were older and had a higher frequency of diabetes mellitus, arterial

hypertension, renal insufficiency, and a history of prior MI, as well as previous

revascularization procedures. In addition, the proportion of patients presenting with

STEMI was also higher than in our study. All these factors are well-known risk factor

for adverse clinical events. Second, China is a developing country where health

insurance and costs are likely to deter most patients from undergoing subsequent

revascularization procedures. As shown in Table 3, 11.4% of patients experienced

recurrent angina, which was treated by medication and not by surgery. This might be

the main reason for the lower rate of revascularization (PCI/CABG) and TVR that we

observed. In addition, we must also take into consideration the influence of different

ethnic groups.

In previous studies, there was a big variation in the incidence of ST. The 0.7%

incidence of ST observed in our study was similar to that reported in four early

randomized DES trials (RAVEL, SIRIUS, C-SIRIUS, and E-SIRIUS), which found

that the 4 year rates of ST according to the Academic Research Consortium

definitions were 0.7% and 0.4% between DES and BMS, when only definite and

probable ST were considered21-24

; however, the incidence of ST was much higher in

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other studies25-26

. ST is a complex multifactorial syndrome where the individual

characteristics of patients, lesions, clinical and procedural factors are all known to

contribute to its risks. It is therefore likely that different baseline clinical and

angiographic characteristics account for the differences observed in previous studies.

A previous study9 demonstrated that SES was better than PES in terms of late stent

thrombosis and target lesion revascularization. In our study, patients were recruited

after the publication of the study. Because the selection of stent type was left to the

operator’s discretion, there may be a selection bias. The sample size was small in the

PES group, and statistically significant differences were observed for the number of

treated vessels, the number of stents per patient, total stent length per patient, and

stent diameter between the two groups; thus attention should be paid to the

interpretation of the results. Nevertheless, our results were consistent with another

previous study27

.

In the present study, older age was an independent predictor of death. This has been

observed in most studies assessing long-term results of treatment28

, and may be due to

the many additional burdens that are typical of older people, which may influence the

long-term follow-up. Prior CABG and chronic total occlusion as predictors of

long-term death may be the result of more complex lesions and more myocardium

damage; therefore worsening the long-term prognosis. Diabetes mellitus and lower

LVEF are well known risk factors for adverse cardiovascular events in CHD patients.

Similarly to a previous study11

, our study showed that age, reduced left ventricular

function (LVEF < 40%) and multi-vessel disease were predictors of MACCE; all of

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these factors were well-known adverse clinical factors for PCI. Previous studies have

identified other clinical variables such as diabetes, renal insufficiency, prior MI, and

cardiogenic shock, plus angiographic variables such as target vessel = bypass graft as

predictors of MACCE. Our study did not find any significant statistical differences in

these variables, but this may be due to the small number of events and patients

included in each of these categories.

In our study, prior PCI, number of treated vessels, total length of stents implanted

(per 10 mm length), and LM lesions were predictors for the occurrence of TVR. In

contrast to a previous study11


not predictors for the occurrence of TVR in our study. This may be due to the lower

frequency of PCI with coronary bypass graft in our study, and to the different

strategies for ostial lesion.

In summary, it is worth emphasizing that the present study proves the safety and

efficacy of DES in everyday practice and provides additional information on the

long-term results of PCI in China.

Study limitation

This is an observational single-center registry and may have an inherent bias

common to this type of study. Furthermore, follow-up angiography was only

performed on 23.8% of patients; therefore, the rate of in-stent restenosis might be

underestimated. In addition, we did not have data on stent strut thickness and the type

of stent platform used.

CONCLUSIONS

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The data from a ‘‘real-world’’ registry on the use of DES in 2,533 patients showed

that both early and long-term prognosis of CHD patients undergoing PCI depends on

clinical presentation, as follows: 1) Patients with STEMI have the worst prognosis,

while patients with stable CHD have the best prognosis; 2) The highest relative

increase in mortality after discharge of patients undergoing PCI was in the

NSTE-ACS group; and 3) The incidence of cardiac death and myocardial infarction

were lower with SES than with PES. The most well-recognized risk factors for death

in patients with CHD are still of great importance for the negative prognosis of

patients after PCI. The main predictors of MACCE were both clinical and


interventional parameters.

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Source of funding: This study was supported by the National Natural Science


Innovation of the Henan Province (NO.201203035), Innovative investigators project

grant from the Health Bureau of the Henan Province, Program Grant for Science &

Technology Innovation Talents in Universities of the Henan Province

(2012HASTIT001), Henan Provincial Science and Technology Achievement

Transformation Project (122102310581), Henan Province of Medical Scientific

Province & Ministry Research Project (201301005), and Henan Province of Medical

Scientific Research Project (201203027), China.

Contributors HMY participated in the coordination of the study, the study design,

interpretation of the results, and manuscript drafting. HMY, YDW, and XJZ

participated in the study design, performed the analysis, and interpreted the results.

DLS, JYZ and LL contributed to the study design and interpretation of the results.

LSZ and TWS contributed to the study design and provided feedback on the

manuscript. TWS conceive the study, participated in its design and interpretation,

helped to draft the manuscript and provided feedback on the manuscript. All authors

read and approved the final manuscript.



University


Data sharing statement No additional data are available.

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Table 1. Baseline characteristics of the study population according to clinical presentation.

Urgent PCI

(n=99)

Delayed PCI

(520)

NSTE-ACS

(1,496)

SA

(n=418)

Total

（（（（n=2,533））））

P-value

Age (years) 58±12.6 57.9±11.5 60.5±10.8 61±10.9 59.9±11.1 < 0.001

Male gender, n (%) 79(80.6) 397(76.2) 948(63.3) 301(71.8) 1,723(68) < 0.001

BMI (kg/m2) 22.5±3.95 22.9±4.03 24.3±3.6 24.1±3.6 23.9±3.8 < 0.001

Systolic BP (mmHg) 98.9±26.7 99.2±28.5 103.6±28.4 109.4±30.2 103.3±28.8 < 0.001

Diastolic BP (mmHg) 76.8±13.9 76.6±12.6 77.0±11.6 78.9±12.3 77.2±12.0 0.109

Prior PCI, n (%) 3(3) 13(2.5) 116(7.8) 40(9.5) 172(6.8) < 0.001

Prior CABG, n (%) 0(0) 0(0) 18(1.2) 3(0.7) 21(0.8) 0.05

OMI, n (%) 2(2) 14(2.7) 70(4.7) 149(35.6) 235(9.3) < 0.001

PVD, n (%) 0(0) 1(0.2) 2(0.1) 3(0.7) 6(0.2) 0.169

LVEF, (mean ± SD) 59.2±6.63 57.4±8.14 62.5±6.38 59.4±8.58 60.9±7.45 < 0.001

LVEF ≤ 40%, n (%) 0(0) 10 (2.9) 12 (1.2) 15 (6.3) 37 (2.3) < 0.001

Risk factors, n (%)

Hypertension 39(39.4) 217(41.7) 826(55.2) 164(39.2) 1,249(49.2) < 0.001


Dyslipidemia 57(58.3) 321(61.8) 800(53.5) 201(48.1) 1,379(54.4) < 0.001

Current smoker 38(38.4) 180(34.5) 373(25) 80(19.1) 671(26.5) < 0.001


Presence of shock, n(%) 3(3) 1(1.2) 0(0) 0(0) 4(0.2) < 0.001

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TC (mmol/L) 4.47±0.99 4.13±0.12 4.31±1.08 4.18±1.05 4.26±1.06 0.92

TG (mmol/L) 1.73±0.89 1.78±1.04 1.99±1.48 1.81±1.1 1.91±135 0.162

LDL-C (mmol/L) 2.99±0.99 2.59±0.87 2.7±0.95 2.59±0.91 2.67±0.94 0.177

HDL-C (mmol/L) 1.04±0.26 0.99±0.29 1.09±0.33 1.05±0.31 1.06±0.32 0.001

Glycemia (mmol/L) 7.97±3.5 6.61±5.17 5.78±2.14 5.8±2.15 6.05±3.15 < 0.001

BMI: body mass index; BP: blood pressure; PCI: percutaneous coronary intervention; CABG:

coronary artery bypass graft; OMI: old myocardial infarction; PVD: peripheral vascular disease;

LVEF: left ventricular ejection fraction; NSTE-ACS: non-ST elevation acute coronary syndromes;

SA: stable angina; TC: total cholesterol; TG: triglyceride; LDL-C: low density lipoprotein

cholesterol; HDL-C: high density lipoprotein cholesterol.

Table 2. Angiographic findings and interventional characteristics according to clinical

presentation.

Urgent PCI

(n=99)

Delayed PCI

(520)

NSTE-ACS

(1,496)

SA

(n=418)

Total

（（（（n=2,533））））

P value

Radial artery accessa 97(98) 511(98.1) 1,458(97.5) 403(96.4) 2,469(97.5) 0.421


1-vessel disease 37(37.4) 196(37.6) 614(41.1) 143(34.2) 990(39.1) 0.065

2-vessel disease 42(42.4) 197(37.8) 528(35.3) 162(38.8) 929(36.7) 0.3

3-vessel disease 20(20.2) 128(24.6) 348(23.3) 110(26.3) 606(23.9) 0.47

Type B2/C lesionb 89(52.7) 593(60.1) 1,744(64.1) 540(66.1) 2,976(63.2) 0.001


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Ostial lesionsa 8(8.1) 64(12.3) 154(10.3) 49(11.7) 275(10.9) 0.443


Number of treated vesselsc 1.36±0.59 1.55±0.67 1.5±0.66 1.57±0.7 1.52±0.67 0.12

Location of target lesionsa

Left main stem 1(1) 15(2.9) 45(3) 14(3.3) 75(3) 0.67

LAD 63(63.6) 405(77.7) 1,037(69.4) 314(75.1) 1,819(71.8) <0.001

LCX 28(28.3) 175(33.6) 573(38.3) 164(39.2) 940(37.1) 0.05

RCA 43(43.4) 216(41.5) 596(39.9) 167(40) 1,022(40.3) 0.842


Number of stents per

patientc

2.04±1.43 2.21±1.23 2.12±1.24 2.26±1.3 2.16±1.26 0.452


patientc

45.5±29.1 51.9±32.1 48.9±32.4 53.4±34.6 50.1±32.6 0.267

Stent diameter (mm)c 3.11±0.45 3.07±0.42 3.08±0.44 3.05±0.42 3.07±0.43 0.363

LAD: left anterior descending artery; LCX: left circumflex artery; NSTE-ACS: non-ST elevation

acute coronary syndromes; PCI: percutaneous coronary intervention; RCA: right coronary artery.

a: n(%); b: Type B2/C, the morphology of the lesion in coronary angiography was classified

according to the criteria of The American College of Cardiology/American Heart Association; c:

mean ± SD.

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Table 3. Clinical events according to clinical presentation, n (%)

Urgent PCI

(n=99)

Delayed PCI

(520)

NSTE-ACS

(1,496)

SA

(n=418)

Total

（（（（n=2,533））））

P-value

In-hospital events (%)

Death 4(4.0) 5(1.0) 7(0.5) 2(0.5) 18(0.7) <0.001

Any MI 0(0) 4(0.8) 7(0.5) 4(1.0) 15(0.6) 0.635

MACE 4(4.0) 9(1.8) 14(1.0) 6(1.5) 33(1.3) 0.001

Follow-up (cumulated events)

(%)

Death 12(12.1) 40(7.7) 108(7.2) 25(6.0) 185(7.3) 0.104

Nonfatal MI 6(6.0) 24(4.6) 66(4.4) 12(2.9) 108(4.3) 0.414

Nonfatal stroke 2(2.0) 9(1.7) 17(1.1) 10(2.4) 38(1.5) 0.267

MACCE 21(21.2) 69(13.3) 203(13.6) 49(11.7) 342(13.5) 0.069


(PCI/CABG)

6(6.1) 36(6.9) 125(8.4) 33(7.9) 200(7.9) 0.632

TVR 2(2.0) 15(2.9) 79(5.3) 26(6.2) 12(4.8) 0.037

In-stent restenosis 5(5.1) 17(3.3) 99(6.6) 25(6.0) 146(5.7) 0.048

Follow-up angiography 21(21.2) 48(19.2) 366(24.5) 115(27.5) 603(23.8) 0.018

Stent thrombosis

(definite/probable)

1(1.0) 4(0.8) 9(0.6) 4(1.0) 15(0.7) 0.859

Recurrent angina 13(13.1) 55(10.6) 9(11.6) 48(11.5) 125(11.4) 0.872

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CABG-coronary bypass grafting; MACE: major adverse cardiac events (death/myocardial

infarction); MACCE: major adverse cardiac and cerebrovascular events (death/myocardial/stroke);

MI: myocardial infarction; NSTE-ACS: non-ST elevation acute coronary syndromes; PCI:

percutaneous coronary intervention; SA: stable angina; TVR: target vessel revascularization.

Table 4. Baseline and procedural characteristics according to DES type

SES

(n=1,650)

PES

(504)

Total

（（（（n=2,154））））

P-value

Age (years) 59.9±11.3 59.2±10.8 59.7±11.2 0.23

Male gender, n(%) 1,133(68.7) 336(66.8) 1,469(68.2) 0.431

BMI (kg/m2) 22.7±8.2 22.9±5.9 22.8±7.7 0.611

Prior PCI, n (%) 119(7.2) 35(7.0) 154(7.2) 0.847

Prior CABG, n (%) 13(0.8) 4(0.8) 17(0.8) 1.0

PVD, n (%) 5(0.3) 1(0.2) 6(0.3) 1.0

LVEF, (mean ± SD) 61.05±7.33 60.85±7.9 61.0.4 0.687

Hypertension 808(49) 229(45.5) 1,037(48.2) 0.176

Diabetes mellitus 327(19.8) 99(19.7) 426(19.8) 0.937

Dyslipidemia 583(50.2) 230(54.0) 813(51.2) 0.182

Current smoker 534(32.4) 166(33) 700(32.5) 0.789

Number of treated vessels 1.45±0.64 1.36±0.58 1.43±0.63 0.002

Number of stents per patientb 2.02±1.17 1.80±1.16 1.97±1.17 0.001

Total stent length per patientb 48.4±31.5 38.3±27.2 46.2±30.9 0.001

Stent diameter (mm)b 3.08±0.0.39 3.13±0.56 3.090.43 0.018

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BMI: body mass index; CABG: coronary bypass grafting; DES: drug-eluting stents; LVEF: left

ventricular ejection fraction; PCI: percutaneous coronary intervention; PES: paclitaxel-eluting

stents; PVD: peripheral vascular disease; SES: sirolimus-eluting stents.

Table 5. Clinical events according to DES type, n (%)

SES

(n=1,650)

PES

(504)

Total

（（（（n=2,154））））

P-value

In-hospital events

Death 12(0.7) 4(0.8) 16(0.7) 0.879

MI 9(0.5) 4(0.8) 13(0.6) 0.53


Death 119(7.2) 39(7.7) 158(7.3) 0.692

Cardiac death 68(4.1) 39(7.7) 107(5.0) 0.002

MI 66(4.0) 33(6.5) 99(4.6) 0.032

TVR 73(4.4) 33 (6.5) 106(4.9) 0.054


(PCI/CABG)

119(7.2) 51(10.1) 170(7.9) 0.034

In-stent restenosis 94(5.7) 39(7.7) 133(6.2) 0.514

Stent thrombosis

(definite/probable)

9(0.5) 4(0.8) 13(0.6) 0.744

CABG: coronary bypass grafting; DES: drug-eluting stents; MI: myocardial infarction; PCI:

percutaneous coronary intervention; PES: paclitaxel-eluting stents; SES: sirolimus-eluting stents;

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TVR: target vessel revascularization.

Table 6. Multivariate analysis of predictors of death, MACCE, and TVR

Wald’s Chi-square HR (95% CI) P-value

Death

Age (years) 21.3 1.08(1.05-1.12) < 0.001

LVEF < 40% 31.4 3.28(2.16-4.98) < 0.001

Diabetes mellitus 7.35 2.38(1.27-4.48) 0.007

Prior CABG 11.74 13.9(3.09-63) 0.001


MACCE

Age (years) 12.6 1.03(1.01-2.2) < 0.001

LVEF < 40% 9.39 2.79(1.45-5.39) 0.002




Target vessel = LM 9.38 2.79(1.45-5.39) 0.002

TVR

Prior PCI 9.84 3.01(1.51-5.98) 0.002


Total length of implanted

stents (per 10 mm length)

1.23 1.23(1.03-1.62) 0.001

LM lesion 5.78 3.06(1.23-7.64) 0.016

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CABG: coronary artery bypass graft; CI: confidence interval; HR: hazards ratio; LM: left main

stem; LVEF: left ventricular ejection fraction; MACCE: major adverse cardiac and

cerebrovascular events; PCI: percutaneous coronary intervention; TVR: target vessel

revascularization..

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coronary intervention with drug-eluting stents：：：：results from a single

large-volume PCI center


2, Xiao-Juan Zhang

2, De-Liang Shen

1, Jin-Ying Zhang

1,


1, Tong-Wen Sun

2

1Department of Cardiology, the First Affiliated Hospital of Zhengzhou University,


2Department of Integrated ICU, the First Affiliated Hospital of Zhengzhou University,





[email protected]

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Abstract


coronary heart disease (CHD) treated with drug-eluting stents (DES) in a

large-volume percutaneous coronary intervention (PCI) center.

Design: Observational cohort study








(MACCE: death/ myocardial infarction/ stroke), and target vessel revascularization

(TVR).


(92.6%). The highest mortality rate during hospitalization was noted within the urgent

PCI group (p <0.001). During follow-up, although death and MACCE were higher in

the urgent PCI group, no significant differences were observed between the different

groups. The incidence of cardiac death and myocardial infarction (MI) was

significantly higher in the paclitaxel-eluting stents (PES) group than in the

sirolimus-eluting stents (SES) group. Independent predictors of death during

follow-up were: age, left ventricular ejection function (LVEF) < 40%, diabetes

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mellitus, prior coronary artery bypass grafting (CABG), and chronic total occlusion.


prognosis. The highest relative increase of mortality after discharge for patients with

CHD undergoing PCI were seen in NSTE-ACS patients；SES seem to be more

effective than PES.

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Article summary

Article focus



large-volume percutaneous coronary intervention (PCI) center in China.

Key messages








patients at different stages of CHD (stable CHD, acute coronary syndrome)


with DES. The end points included death, myocardial infarction (MI), stroke,

TVR, any revascularization, in-stent restenosis, and stent thrombosis.




Innovation of the Henan Province (NO.201203035), Innovative investigators project

grant from the Health Bureau of the Henan Province, Program Grant for Science &

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Technology Innovation Talents in Universities of the Henan Province

(2012HASTIT001), Henan Provincial Science and Technology Achievement

Transformation Project (122102310581), Henan Province of Medical Scientific

Province & Ministry Research Project (201301005), and Henan Province of Medical

Scientific Research Project (201203027), China.



University


Data sharing statement No additional data are available.

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INTRODUCTION


medicine. Myocardial revascularization，i.e. percutaneous coronary intervention (PCI)





pectoris or acute coronary syndromes.


and randomized controlled clinical trials (RCTS)4 -9

have

shown a marked reduction in restenosis and TVR rates with sirolimus-eluting stents

(SES) and paclitaxel-eluting stents (PES) compared to bare metal stents (BMS). Data

from registries, which reflect the clinical use of DES in a more inhomogeneous daily


; however, data from

registries on long-term follow-up，especially in the Chinese population, were sparse.

In addition, advances in interventional cardiology within the last few years have

contributed to the improvement of CHD therapy results; thus it is necessary to

perform a periodical assessment of the treatments. The aim of this study was to assess


large-volume PCI center in China.

METHODS

Study(population


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between July 2009 and August 2011, at a single large-volume PCI center. Only

patients treated with at least one DES, and who completed long-term follow-up

documentation, were recruited for the study. Qualitative and quantitative coronary






intravascular ultrasound (IVUS) were all left to the operator’s discretion. All patients

were prescribed 100 mg/d aspirin indefinitely and clopidogrel 75 mg/d for at least the

first 12 months after the procedure. Patients were divided into four groups according

to their clinical presentation and timing of PCI, as follows: patients with ST elevation


patients with STEMI treated with delayed PCI (delayed PCI) accounted for 20.5% of

cases; patients with SA accounted for 16.5% of cases; and patients with NSTE-ACS

accounted for 58.6% of cases. The NSTE-ACS group consisted of patients with

non-ST elevation myocardial infarction (NSTEMI) and patients with unstable angina

(UA). The study protocol was approved by the ethics committee of the First Affiliated

Hospital of Zhengzhou University, and complied with the Declaration of Helsinki.




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the last 10 years. Patients were classed as having diabetes mellitus if their fasting

plasma glucose concentration was > 6.1 mmol/L or their hemoglobin A1c (HbA1c)

was > 6.5%, or if they were currently being treated with insulin or oral hypoglycemic

agents. Patients were defined as having hypertension if their systolic blood pressure ≥

140 mmHg, their diastolic blood pressure was ≥ 90 mmHg, or if antihypertensive

drugs were prescribed. Patients were diagnosed with dyslipidemia if low-density

lipoprotein cholesterol was > 140 mg/dL, high-density lipoprotein was < 40 mg/dL, or

if lipid-lowering drugs were prescribed. Renal insufficiency was defined if the

creatinine value was > 150 mmol/L. TVR was defined as a repeat procedure, either

PCI or CABG, in the target vessel. Stent thrombosis (ST) was either proven by

angiography or assumed as probable if an unexplained sudden death occurred within

30 days after stent implantation or if a Q-wave myocardial infarction (MI) was

diagnosed in the distribution area of the stented artery. This classification was issued

according to definitions proposed by the Academic Research Consortium (ARC) 12

.

Clinical(outcomes and data collection



all-cause mortality, occurrence of MI, stent thrombosis, and TVR. The composite end

points were defined as major adverse cardiac and cerebrovascular events (MACCE),

namely death, MI, and stroke. Clinical follow-up was carried out through patient

visits, telephone interviews, and medical record reviews. Independent research

personnel entered the data and an independent committee adjudicated clinical events.

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at least one DES. Follow-up after a median of 29.8 months (quartiles 25.6–34 months)

was carried out on 2,533 patients (92.6%).

Statistics

Distribution of variables was assessed using the Kołmogorov-Smirnov test

followed by the Student-t test, ANOVA test, or Mann-Whitney test for comparative



or Fisher’s exact tests. Cox proportional hazards analyses were used to identify risk

factors for the occurrence of MACCE and TVR during follow-up. All baseline,


Results are reported as hazard ratios (HRs) and 95% confidence intervals (CIs). All

statistical tests were 2-tailed, and p-values were statistically significant at < 0.05. All

data were analyzed using SPSS 18.0 software (SPSS, Inc., Chicago, Illinois, USA).

RESULTS


Demographic characteristics of the 2,533 patients enrolled in the study are shown

in Table 1. The mean age was 59.9 ± 11.1 years and 68% of patients were male.


the delayed PCI group had the lowest left ventricular ejection fraction. Patients with

SA were older and had the highest frequency of past MI and a history of previous

revascularization procedures. The percentage of patients with a history of

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groups (p <0.001). Patients with delayed PCI had the highest frequency of


<Table 1 near here>



study groups did not differ in interventional characteristics except for a higher

frequency of left anterior descending coronary artery intervention within the STEMI

group, and a higher frequency of left circumflex coronary artery intervention within


<Table 2 near here>


In-hospital event rates were low. The highest mortality rate was noted within the

urgent PCI group and the lowest rate was observed within the SA group (p < 0.001).

The highest incidence of MACE was noted within the urgent PCI group and the

lowest incidence of MACE was noted within the NSTE-ACS group (p = 0.001).

During the mean follow-up of 29 months, the incidence of death and MACCE were

higher in the urgent PCI group, but no significant differences were observed between

the groups. The highest frequency of TVR was noted within the SA group and the

lowest frequency was noted within the urgent PCI group (p = 0.001). The highest

frequency of in-stent restenosis was noted within the NSTE-ACS group and the

lowest frequency was noted within the delayed PCI group (p = 0.048) (Table 3).

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<Table 3 near here>


subanalysis. Out of a total of 1,650 patients treated with SES, 504 patients were

treated with PES and 379 patients were treated with a mixture of different types of

DES. The baseline and procedural characteristics according to SES and PES are

shown in Table 4. Significant differences between the two groups were observed in

the number of treated vessels, the number of stents per patient, total stent length per

patient, and stent diameter. During follow-up, the incidence of cardiac death and MI

was significantly higher in the PES group than in the SES group，and although the

incidence of TVR was also higher in the PES group, this was not statistically

significant (P >0.05) (Table 5).


According to the Cox proportional hazards analysis, age, left ventricular ejection

fraction (LVEF) < 40%, prior CABG, diabetes mellitus, and chronic total occlusion

were identified as independent predictors of death; while age, LVEF < 40 %,

multi-vessel disease, diastolic blood pressure, chronic total occlusion, and target

vessel = left main (LM) were identified as independent predictors of MACCE. By

contrast, independent predictors of TVR were prior PCI, number of treated vessels,

total length of implanted stents (per 10 mm length), and LM lesions (Table 6).

<Table 6 near here>

DISCUSSION

At present, interventional treatment for patients with CHD is common in China and

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throughout the world, and its efficacy has been proven in many trials. Numerous

studies have shown higher mortality rate in registries than in randomized clinical

trials13,14

, which prove the selectivity of choice of examined populations in

randomized trials. Registry data reflecting clinical practice gives a more clinically

relevant estimate of ‘‘real’’ occurrence rates for clinical as well as TVR rates than data

from randomized controlled trials.


treatments at our center over a defined period of time, and from the data we gather the

following information: death occurred in 7.3% of patients, the incidence of MACCE

in 13.5%, the rate of stent thrombosis in 0.7%, and the incidence of TVR was 4.8%.

The highest incidence of in-hospital mortality and MACE was noted within the urgent

PCI group. During follow-up, the highest frequency of TVR was noted within the SA

group, and the highest frequency of in-stent restenosis was noted within the

NSTE-ACS group. The incidence of cardiac death and MI were significantly higher in

the PES group than in the SES group.

According to previous data from other registries, the rate of hospital mortality is

higher in patients with STEMI than in patients with NSTE-ACS (7% and 5%,

respectively). However, after six months the mortality rate is very similar (12% vs.

13%, respectively)15, 16

. The results of the longer follow-up showed that the mortality

rates for patients who survived until the end of hospitalization was two times higher in

patients with NSTE-ACS than in patients with STEMI17

. In these studies, almost all

patients with STEMI received urgent PCI; however, in our hospital, because most

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patients came from the countryside, the majority of those with STEMI were first

treated at a local hospital and then transferred to our center for PCI. Therefore only

16% of patients with STEMI received urgent PCI, and the rest received delayed PCI.

It is well known that patients with urgent PCI experience higher morality rates, so,

because of this, we assessed the long-term results of the interventional treatment on

different groups of patients with CHD.

Controversy over the justification of interventional treatments in all patients with

stable CHD and the different strategies for patients with NSTE-ACS, underlines the

need to perform similar analyses. In the present study, patients with SA accounted for




treatment18

. In our study, patients with SA were older and had a higher frequency of

past MI as well as a history of previous revascularization procedures. The in-hospital

mortality rate for patients with SA was 0.5%, which proves the high efficacy and

safety of the interventional treatment; the 6% mortality rate observed at the 29 month

follow-up was also low.

At present, a reduction in mortality rates is confirmed in patients with STEMI

treated with urgent PCI. In our study, 520 patients with STEMI received delayed PCI,

and 63% of them had occluded infarction related arteries. It is worth noting that

current guidelines recommend not performing delayed PCI on a totally occluded

infarct artery 24 hours after STEMI, in asymptomatic patients with 1- or 2-vessel

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disease if they are hemodynamically and electrically stable and show no evidence of

severe ischemia19

. Because our data was collected before this guideline was published,

it was not further classified into different clinical conditions. Death observed both

in-hospital and during follow-up were far fewer than for urgent PCI; however,

mortality rates markedly increased during the follow-up. In contrast to a previously

published study20

, where all patients with NSTE-ACS received early interventional

treatment after confirming ACS (within 24 hours of admission), in the present study

only high-risk patients received early intervention. Similar to a previous study20

, the

NSTE-ACS group showed a significant increase in mortality after hospitalization,

which was the highest of all analyzed populations: from 0.5% during hospitalization

to 7.2% during the 29 month follow-up. These results are in line with current

knowledge on acute coronary syndrome (ACS)15-17

, and could be associated with

more complex lesions before PCI (Table 2). Although mortality in the delayed PCI

was lower than in the urgent PCI group, it increased markedly during follow-up. The

higher long-term mortality in patients with STEMI compared to patients with

NSTE-ACS observed in our study is not consistent with previous studies, and might

be the result of worse systolic function of the left ventricle and a higher frequency of

renal insufficiency compared to the NSTE-ACS and SA groups. In the present study,

both in-hospital and follow-up mortality rates were lower than those reported in

previous study20


underwent urgent PCI (3.9% vs. 50%). It is well known that patients with STEMI

who are treated with urgent PCI experience higher mortality rates.

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, in-hospital mortality, MI and MACE

(death/myocardial infarction) rates were similar to those observed in our study.

However, during a mean follow-up of 4.1 years, clinical events in the multi-center

registry were higher than in our study, especially the rate of any revascularization

(PCI/CABG) and TVR. There are several possible explanations for this. First, patients

in this registry were older and had a higher frequency of diabetes mellitus, arterial

hypertension, renal insufficiency, and a history of prior MI, as well as previous

revascularization procedures. In addition, the proportion of patients presenting with

STEMI was also higher than in our study. All these factors are well-known risk factor




recurrent angina, which was treated by medication and not by surgery. This might be

the main reason for the lower rate of revascularization (PCI/CABG) and TVR that we

observed. In addition, we must also take into consideration the influence of different

ethnic groups.

In previous studies, there was a big variation in the incidence of ST. The 0.7%

incidence of ST observed in our study was similar to that reported in four early

randomized DES trials (RAVEL, SIRIUS, C-SIRIUS, and E-SIRIUS), which found

that the 4 year rates of ST according to the Academic Research Consortium

definitions were 0.7% and 0.4% between DES and BMS, when only definite and

probable ST were considered21-24

; however, the incidence of ST was much higher in

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other studies25-26

. ST is a complex multifactorial syndrome where the individual

characteristics of patients, lesions, clinical and procedural factors are all known to

contribute to its risks. It is therefore likely that different baseline clinical and

angiographic characteristics account for the differences observed in previous studies.

A previous study9 demonstrated that SES was better than PES in terms of late stent


after the publication of the study. Because the selection of stent type was left to the

operator’s discretion, there may be a selection bias. The sample size was small in the

PES group, and statistically significant differences were observed for the number of

treated vessels, the number of stents per patient, total stent length per patient, and

stent diameter between the two groups; thus attention should be paid to the

interpretation of the results. Nevertheless, our results were consistent with another

previous study27

.


observed in most studies assessing long-term results of treatment28

, and may be due to

the many additional burdens that are typical of older people, which may influence the

long-term follow-up. Prior CABG and chronic total occlusion as predictors of

long-term death may be the result of more complex lesions and more myocardium

damage; therefore worsening the long-term prognosis. Diabetes mellitus and lower

LVEF are well known risk factors for adverse cardiovascular events in CHD patients.



function (LVEF < 40%) and multi-vessel disease were predictors of MACCE; all of

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these factors were well-known adverse clinical factors for PCI. Previous studies have

identified other clinical variables such as diabetes, renal insufficiency, prior MI, and

cardiogenic shock, plus angiographic variables such as target vessel = bypass graft as

predictors of MACCE. Our study did not find any significant statistical differences in

these variables, but this may be due to the small number of events and patients

included in each of these categories.

In our study, prior PCI, number of treated vessels, total length of stents implanted

(per 10 mm length), and LM lesions were predictors for the occurrence of TVR. In

contrast to a previous study11


not predictors for the occurrence of TVR in our study. This may be due to the lower

frequency of PCI with coronary bypass graft in our study, and to the different

strategies for ostial lesion.




Study limitation




underestimated. In addition, we did not have data on stent strut thickness and the type

of stent platform used.

CONCLUSIONS

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that both early and long-term prognosis of CHD patients undergoing PCI depends on

clinical presentation, as follows: 1) Patients with STEMI have the worst prognosis,

while patients with stable CHD have the best prognosis; 2) The highest relative

increase in mortality after discharge of patients undergoing PCI was in the

NSTE-ACS group; and 3) The incidence of cardiac death and myocardial infarction

were lower with SES than with PES. The most well-recognized risk factors for death

in patients with CHD are still of great importance for the negative prognosis of

patients after PCI. The main predictors of MACCE were both clinical and


interventional parameters.






manuscript. TWS conceive the study, participated in its design and interpretation,

helped to draft the manuscript and provided feedback on the manuscript. All authors


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REFERENCES



41:184–189




Circulation 2001; 103:192–195










Circulation 2003; 107:517–52



349:1315–1323


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370:937–948.




J 2006; 152:1146–1152.




101:709-16.







114:c173-7.


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assessing respective strengths and limitations. JACC Cardiovasc Interv 2008;

1:211-7.




80:40-4.








Med 2007; 356:1503-16.




e362-425.




2011; 56: 222-230.

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Cardiol 2007; 50:1299-304.
















after intracoronary stent implantation. World J Emerg Med 2012; 3:197-201.

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Urgent PCI

(n=99)

Delayed PCI

(520)

NSTE-ACS

(1,496)

SA

(n=418)

Total

（（（（n=2,533））））

P-value

Age (years) 58±12.6 57.9±11.5 60.5±10.8 61±10.9 59.9±11.1 < 0.001

Male gender, n (%) 79(80.6) 397(76.2) 948(63.3) 301(71.8) 1,723(68) < 0.001

BMI (kg/m2) 22.5±3.95 22.9±4.03 24.3±3.6 24.1±3.6 23.9±3.8 < 0.001

Systolic BP (mmHg) 98.9±26.7 99.2±28.5 103.6±28.4 109.4±30.2 103.3±28.8 < 0.001


Prior PCI, n (%) 3(3) 13(2.5) 116(7.8) 40(9.5) 172(6.8) < 0.001

Prior CABG, n (%) 0(0) 0(0) 18(1.2) 3(0.7) 21(0.8) 0.05

OMI, n (%) 2(2) 14(2.7) 70(4.7) 149(35.6) 235(9.3) < 0.001

PVD, n (%) 0(0) 1(0.2) 2(0.1) 3(0.7) 6(0.2) 0.169

LVEF, (mean ± SD) 59.2±6.63 57.4±8.14 62.5±6.38 59.4±8.58 60.9±7.45 < 0.001

LVEF ≤ 40%, n (%) 0(0) 10 (2.9) 12 (1.2) 15 (6.3) 37 (2.3) < 0.001

Risk factors, n (%)

Hypertension 39(39.4) 217(41.7) 826(55.2) 164(39.2) 1,249(49.2) < 0.001


Dyslipidemia 57(58.3) 321(61.8) 800(53.5) 201(48.1) 1,379(54.4) < 0.001

Current smoker 38(38.4) 180(34.5) 373(25) 80(19.1) 671(26.5) < 0.001


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Presence of shock, n (%) 3(3) 1(1.2) 0(0) 0(0) 4(0.2) < 0.001

TC (mmol/L) 4.47±0.99 4.13±0.12 4.31±1.08 4.18±1.05 4.26±1.06 0.92

TG (mmol/L) 1.73±0.89 1.78±1.04 1.99±1.48 1.81±1.1 1.91±135 0.162

LDL-C (mmol/L) 2.99±0.99 2.59±0.87 2.7±0.95 2.59±0.91 2.67±0.94 0.177

HDL-C (mmol/L) 1.04±0.26 0.99±0.29 1.09±0.33 1.05±0.31 1.06±0.32 0.001

Glycemia (mmol/L) 7.97±3.5 6.61±5.17 5.78±2.14 5.8±2.15 6.05±3.15 < 0.001

BMI: body mass index; BP: blood pressure; PCI: percutaneous coronary intervention; CABG:

coronary artery bypass graft; OMI: old myocardial infarction; PVD: peripheral vascular disease;

LVEF: left ventricular ejection fraction; NSTE-ACS: non-ST elevation acute coronary syndromes;

SA: stable angina; TC: total cholesterol; TG: triglyceride; LDL-C: low density lipoprotein

cholesterol; HDL-C: high density lipoprotein cholesterol.


presentation.

Urgent PCI

(n=99)

Delayed PCI

(520)

NSTE-ACS

(1,496)

SA

(n=418)

Total

（（（（n=2,533））））

P value

Radial artery accessa 97(98) 511(98.1) 1,458(97.5) 403(96.4) 2,469(97.5) 0.421


1-vessel disease 37(37.4) 196(37.6) 614(41.1) 143(34.2) 990(39.1) 0.065

2-vessel disease 42(42.4) 197(37.8) 528(35.3) 162(38.8) 929(36.7) 0.3

3-vessel disease 20(20.2) 128(24.6) 348(23.3) 110(26.3) 606(23.9) 0.47

Type B2/C lesionb 89(52.7) 593(60.1) 1,744(64.1) 540(66.1) 2,976(63.2) 0.001

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Ostial lesionsa 8(8.1) 64(12.3) 154(10.3) 49(11.7) 275(10.9) 0.443


Number of treated vesselsc 1.36±0.59 1.55±0.67 1.5±0.66 1.57±0.7 1.52±0.67 0.12

Location of target lesionsa

Left main stem 1(1) 15(2.9) 45(3) 14(3.3) 75(3) 0.67

LAD 63(63.6) 405(77.7) 1,037(69.4) 314(75.1) 1,819(71.8) <0.001

LCX 28(28.3) 175(33.6) 573(38.3) 164(39.2) 940(37.1) 0.05

RCA 43(43.4) 216(41.5) 596(39.9) 167(40) 1,022(40.3) 0.842


Number of stents per

patientc

2.04±1.43 2.21±1.23 2.12±1.24 2.26±1.3 2.16±1.26 0.452


patientc

45.5±29.1 51.9±32.1 48.9±32.4 53.4±34.6 50.1±32.6 0.267

Stent diameter (mm)c 3.11±0.45 3.07±0.42 3.08±0.44 3.05±0.42 3.07±0.43 0.363


acute coronary syndromes; PCI: percutaneous coronary intervention; RCA: right coronary artery.

a: n(%); b: Type B2/C, the morphology of the lesion in coronary angiography was classified

according to the criteria of The American College of Cardiology/American Heart Association; c:

mean ± SD.

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Table 3. Clinical events according to clinical presentation, n (%)

Urgent PCI

(n=99)

Delayed PCI

(520)

NSTE-ACS

(1,496)

SA

(n=418)

Total

（（（（n=2,533））））

P-value

In-hospital events (%)

Death 4(4.0) 5(1.0) 7(0.5) 2(0.5) 18(0.7) <0.001

Any MI 0(0) 4(0.8) 7(0.5) 4(1.0) 15(0.6) 0.635

MACE 4(4.0) 9(1.8) 14(1.0) 6(1.5) 33(1.3) 0.001


(%)

Death 12(12.1) 40(7.7) 108(7.2) 25(6.0) 185(7.3) 0.104

Nonfatal MI 6(6.0) 24(4.6) 66(4.4) 12(2.9) 108(4.3) 0.414

Nonfatal stroke 2(2.0) 9(1.7) 17(1.1) 10(2.4) 38(1.5) 0.267

MACCE 21(21.2) 69(13.3) 203(13.6) 49(11.7) 342(13.5) 0.069


(PCI/CABG)

6(6.1) 36(6.9) 125(8.4) 33(7.9) 200(7.9) 0.632

TVR 2(2.0) 15(2.9) 79(5.3) 26(6.2) 12(4.8) 0.037



Stent thrombosis

(definite/probable)

1(1.0) 4(0.8) 9(0.6) 4(1.0) 15(0.7) 0.859

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CABG-coronary bypass grafting; MACE: major adverse cardiac events (death/myocardial

infarction); MACCE: major adverse cardiac and cerebrovascular events (death/myocardial/stroke);

MI: myocardial infarction; NSTE-ACS: non-ST elevation acute coronary syndromes; PCI:

percutaneous coronary intervention; SA: stable angina; TVR: target vessel revascularization.

Table 4. Baseline and procedural characteristics according to DES type

SES

(n=1,650)

PES

(504)

Total

（（（（n=2,154））））

P-value

Age (years) 59.9±11.3 59.2±10.8 59.7±11.2 0.23

Male gender, n(%) 1,133(68.7) 336(66.8) 1,469(68.2) 0.431

BMI (kg/m2) 22.7±8.2 22.9±5.9 22.8±7.7 0.611

Prior PCI, n (%) 119(7.2) 35(7.0) 154(7.2) 0.847

Prior CABG, n (%) 13(0.8) 4(0.8) 17(0.8) 1.0

PVD, n (%) 5(0.3) 1(0.2) 6(0.3) 1.0

LVEF, (mean ± SD) 61.05±7.33 60.85±7.9 61.0.4 0.687

Hypertension 808(49) 229(45.5) 1,037(48.2) 0.176

Diabetes mellitus 327(19.8) 99(19.7) 426(19.8) 0.937

Dyslipidemia 583(50.2) 230(54.0) 813(51.2) 0.182

Current smoker 534(32.4) 166(33) 700(32.5) 0.789


Number of stents per patientb 2.02±1.17 1.80±1.16 1.97±1.17 0.001

Total stent length per patientb 48.4±31.5 38.3±27.2 46.2±30.9 0.001

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Stent diameter (mm)b 3.08±0.0.39 3.13±0.56 3.090.43 0.018

BMI: body mass index; CABG: coronary bypass grafting; DES: drug-eluting stents; LVEF: left



Table 5. Clinical events according to DES type, n (%)

SES

(n=1,650)

PES

(504)

Total

（（（（n=2,154））））

P-value

In-hospital events

Death 12(0.7) 4(0.8) 16(0.7) 0.879

MI 9(0.5) 4(0.8) 13(0.6) 0.53


Death 119(7.2) 39(7.7) 158(7.3) 0.692

Cardiac death 68(4.1) 39(7.7) 107(5.0) 0.002

MI 66(4.0) 33(6.5) 99(4.6) 0.032

TVR 73(4.4) 33 (6.5) 106(4.9) 0.054


(PCI/CABG)

119(7.2) 51(10.1) 170(7.9) 0.034


Stent thrombosis

(definite/probable)

9(0.5) 4(0.8) 13(0.6) 0.744

CABG: coronary bypass grafting; DES: drug-eluting stents; MI: myocardial infarction; PCI:

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Table 6. Multivariate analysis of predictors of death，MACCE, and TVR


Death

Age (years) 21.3 1.08(1.05-1.12) < 0.001

LVEF < 40% 31.4 3.28(2.16-4.98) < 0.001


Prior CABG 11.74 13.9(3.09-63) 0.001


MACCE

Age (years) 12.6 1.03(1.01-2.2) < 0.001

LVEF < 40% 9.39 2.79(1.45-5.39) 0.002




Target vessel = LM 9.38 2.79(1.45-5.39) 0.002

TVR

Prior PCI 9.84 3.01(1.51-5.98) 0.002



stents (per 10 mm length)

1.23 1.23(1.03-1.62) 0.001

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LM lesion 5.78 3.06(1.23-7.64) 0.016


stem; LVEF: left ventricular ejection fraction MACCE: major adverse cardiac and cerebrovascular

events; PCI: percutaneous coronary intervention; TVR: target vessel revascularization.

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Section/Topic Item




Introduction



Methods



collection

7




applicable

7

Data sources/

measurement



7




why

8






Results

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9




confounders

10






11




Discussion


Limitations 19



19


Other information



3





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Long-term follow-up results in patients undergoing percutaneous coronary intervention (PCI) with drug-eluting

stents：：：：results from a single high-volume PCI center

Journal: BMJ Open



Date Submitted by the Author: 01-Jun-2014

Complete List of Authors: Yao, Hai-Mu; the First Affiliated Hospital of Zhengzhou University, Department of Cardiology Wan, You-Dong; the First Affiliated Hospital of Zhengzhou University, Department of Integrated ICU Zhang, Xiao-Juan; the First Affiliated Hospital of Zhengzhou University, Department of Integrated ICU Shen, De-Liang; the First Affiliated Hospital of Zhengzhou University, Department of Cardiology Zhang, Jin-Ying; the First Affiliated Hospital of Zhengzhou University,

Department of Cardiology Li, Ling; the First Affiliated Hospital of Zhengzhou University, Department of Cardiology Zhao, Luo-Sha; the First Affiliated Hospital of Zhengzhou University, Department of Cardiology Sun, Tong-Wen; the First Affiliated Hospital of Zhengzhou University, Department of Integrated ICU




Keywords: Coronary intervention < CARDIOLOGY, Myocardial infarction < CARDIOLOGY, Cardiology < INTERNAL MEDICINE, Clinical trials <

THERAPEUTICS


BMJ Open on M


http://bmjopen.bm

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coronary intervention (PCI) with drug-eluting stents：：：：results from a single

high-volume PCI center


2, Xiao-Juan Zhang

2, De-Liang Shen

1, Jin-Ying Zhang

1,


1, and Tong-Wen Sun

2

1Department of Cardiology, The First Affiliated Hospital of Zhengzhou University,


2Department of Integrated ICU, The First Affiliated Hospital of Zhengzhou University,



Care Unit, The First Affiliated Hospital, Zhengzhou University, 1 Jianshe East Road,


[email protected]

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Abstract


coronary heart disease (CHD) treated with drug-eluting stents (DES) in a high-volume

percutaneous coronary intervention (PCI) center.

Design: Observational cohort study.








(MACCE: death/myocardial infarction/stroke), and target vessel revascularization.


(92.6%). The mortality rate during hospitalization was highest in the urgent PCI group

(p <0.001). During follow-up, although the incidences of death and MACCE were

highest in the urgent PCI group, no significant differences were observed between the

different groups. The incidences of cardiac death and myocardial infarction were

significantly higher in the paclitaxel-eluting stent (PES) group than in the

sirolimus-eluting stent (SES) group. Independent predictors of death during follow-up

were: age, left ventricular ejection function (LVEF) < 40%, diabetes mellitus, prior

coronary artery bypass graft (CABG), and chronic total occlusion.

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prognosis. The mortality rate after hospital increased markedly in NSTE-ACS patients.

SES seems to be more effective than PES.

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Article summary

Article focus



high-volume percutaneous coronary intervention (PCI) center in China.

Key messages








patients at different stages of CHD (stable CHD, acute coronary syndrome).


with DES. The end points included death, myocardial infarction, stroke, TVR,

in-stent restenosis, and stent thrombosis.


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INTRODUCTION


medicine. Myocardial revascularization，i.e., percutaneous coronary intervention (PCI)

and coronary artery bypass graft (CABG), are of great importance in the proper




pectoris or acute coronary syndromes (ACS).


and randomized controlled clinical trials4 -9

have shown a

marked reduction in restenosis and TVR rates with sirolimus-eluting stents (SES) and

paclitaxel-eluting stents (PES) compared to bare metal stents (BMS). Data from

registries, which reflect the clinical use of DES in a more inhomogeneous daily


. However, data from

registries on long-term follow-up, especially in the Chinese population, are sparse. In

addition, advances in interventional cardiology within the last few years have

contributed to the improvement of CHD therapy results; thus, it is necessary to

perform a periodic assessment of the treatments. The aim of this study was to assess


high-volume PCI center in China.

METHODS

Study population


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between July 2009 and August 2011, at a single high-volume PCI center. Only

patients treated with at least one DES and who completed long-term follow-up

documentation were recruited to the study. Qualitative and quantitative coronary






intravascular ultrasound were all left to the surgeon’s discretion. All patients were

prescribed 100 mg/d aspirin indefinitely and clopidogrel 75 mg/d for at least the first

12 months after the procedure. Patients were divided into four groups according to

their clinical presentation and timing of PCI as follows: patients with ST-elevation

myocardial infarction (STEMI) treated with urgent PCI (urgent PCI) accounted for

3.9% of cases, patients with STEMI treated with delayed PCI (delayed PCI)

accounted for 20.5% of cases, patients with SA accounted for 16.5% of cases, and

patients with non-ST elevation acute coronary syndromes (NSTE-ACS) accounted for

58.6% of cases. The NSTE-ACS group consisted of patients with non-ST elevation

myocardial infarction (MI) and patients with unstable angina. The study protocol was

approved by the ethics committee of The First Affiliated Hospital of Zhengzhou

University and complied with the Declaration of Helsinki.



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the previous 10 years. Patients were classed as having diabetes mellitus if their fasting

plasma glucose concentration was > 6.1 mmol/L, their hemoglobin A1c level was >

6.5%, or they were currently being treated with insulin or oral hypoglycemic agents.

Patients were defined as having hypertension if their systolic blood pressure was ≥

140 mmHg, or their diastolic blood pressure was ≥ 90 mmHg, or they were prescribed

antihypertensive drugs. Patients were diagnosed with dyslipidemia if their low-density

lipoprotein cholesterol concentration was > 140 mg/dL, their high-density lipoprotein

concentration was < 40 mg/dL, or they were prescribed lipid-lowering drugs. Renal

insufficiency was defined as a creatinine concentration of > 150 mmol/L. TVR was

defined as a repeat procedure, either PCI or CABG, in the target vessel. Stent

thrombosis was either proven by angiography or assumed as probable if an

unexplained sudden death occurred within 30 days after stent implantation or if a

Q-wave MI was diagnosed in the distribution area of the stented artery. This

classification was issued according to definitions proposed by the Academic Research

Consortium 12

.

Clinical outcomes and data collection



all-cause mortality and the occurrence of MI, stent thrombosis, and TVR. The

composite end points were defined as major adverse cardiac and cerebrovascular

events (MACCE), namely death, MI, and stroke. Clinical follow-up was carried out

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through patient visits, telephone interviews, and medical record reviews. Independent

research personnel entered the data and an independent committee adjudicated clinical

events. Between July 2009 and August 2011, 2,735 patients at our hospitals were

treated with at least one DES. Follow-up after a median of 29.8 months (quartiles,

25.6–34 months) was carried out on 2,533 patients (92.6%).

Statistics

The distribution of variables was assessed using the Kołmogorov-Smirnov test

followed by the Student t-test, ANOVA, or Mann-Whitney test for comparative



or Fisher’s exact test. Cox proportional hazards analyses were used to identify risk

factors for the occurrence of death, MACCE and TVR during follow-up. All baseline,


Results are reported as hazard ratios and 95% confidence intervals. All statistical tests

were two-tailed, and p-values were statistically significant at < 0.05. All data were

analyzed using SPSS 18.0 software (SPSS, Inc., Chicago, Illinois, USA).

RESULTS


The demographic characteristics of the 2,533 patients enrolled in the study are

shown in Table 1. The mean age was 59.9 ± 11.1 years and 68% of patients were male.


the delayed PCI group had the lowest left ventricular ejection fraction (LVEF).

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Patients with SA were older and had the highest frequency of past MI and a history of

previous revascularization procedures. The percentage of patients with a history of


groups (p <0.001). Patients with delayed PCI had the highest frequencies of


<Table 1 near here>



study groups did not differ in interventional characteristics, except that the frequency

of left anterior descending coronary artery intervention was higher in the delayed PCI

group, and the frequency of left circumflex coronary artery intervention was higher in


<Table 2 near here>


In-hospital event rates were low. The mortality rate was highest in the urgent PCI

group and lowest in the SA group (p < 0.001). The incidence of major adverse cardiac

events was highest in the urgent PCI group and lowest in the NSTE-ACS group (p =

0.001).

During the mean follow-up of 29 months, the incidences of death and MACCE

were highest in the urgent PCI group, but no significant differences were observed

among the groups. The frequency of TVR was highest in the SA group and lowest in

the urgent PCI group (p = 0.001). The frequency of in-stent restenosis was highest in

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the NSTE-ACS group and lowest in the delayed PCI group (p = 0.048) (Table 3).

<Table 3 near here>


sub-analysis. In total, 1,650 patients were treated with SES, 504 patients were treated

with PES, and 379 patients were treated with a mixture of different types of DES. The

baseline and procedural characteristics according to whether patients were treated

with SES or PES are shown in Table 4. Significant differences were observed between

the two groups in term of the number of treated vessels, the number of stents per

patient, the total stent length per patient, and the stent diameter. During the follow-up,

the incidences of cardiac death and MI were significantly higher in the PES group

than in the SES group. Although the incidence of TVR was also higher in the PES

group than in the SES group, this was not statistically significant (P >0.05) (Table 5).


According to Cox proportional hazards analysis, age, LVEF < 40%, prior CABG,

diabetes mellitus, and chronic total occlusion were identified as independent

predictors of death. Furthermore, age, LVEF < 40%, multi-vessel disease, diastolic

blood pressure, chronic total occlusion, and left main (LM) target vessel were

identified as independent predictors of MACCE. By contrast, independent predictors

of TVR were prior PCI, number of treated vessels, total length of implanted stents,

and LM lesions (Table 6).

<Table 6 near here>

DISCUSSION

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Interventional treatment of patients with CHD is common in China and throughout

the world, and its efficacy has been proven in many trials. Numerous studies have

shown higher mortality rates in registries than in randomized clinical trials13,14

, which

is likely because specific populations are examined in randomized trials. In

comparison to data from randomized controlled trials, registry data reflecting clinical

practice gives a more clinically relevant estimate of clinical events as well as TVR

rates.


treatments at our center over a defined period of time. From the data, we gathered the

following information: 7.3% of patients died, the incidence of MACCE was 13.5%,

the incidence of stent thrombosis was 0.7%, and the incidence of TVR was 4.8%. The

incidences of in-hospital mortality and major adverse cardiac events were highest in

the urgent PCI group. During follow-up, the frequency of TVR was highest in the SA

group, and the frequency of in-stent restenosis was highest in the NSTE-ACS group.

The incidences of cardiac death and MI were significantly higher in the PES group

than in the SES group.

According to data from other registries, the rate of hospital mortality is higher in

patients with STEMI than in patients with NSTE-ACS (7% and 5%, respectively).

However, 6 months after hospital discharge, the mortality rate is very similar in

STEMI and NSTE-ACS patients (12% vs. 13%, respectively)15, 16

. A longer follow-up

study showed that in patients who survived until the end of hospitalization, the

mortality rate was 2-fold higher in patients with NSTE-ACS than in patients with

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STEMI17

. In these studies, almost all patients with STEMI received urgent PCI.

However, in our hospital, most patients came from the countryside; therefore, the

majority of those with STEMI were first treated at a local hospital and the survivors

were then transferred to our center for PCI. Consequently, only 16% of patients with

STEMI received urgent PCI; the rest received delayed PCI. Therefore, we assessed

the long-term results of interventional treatment among different groups of patients

with CHD.

Controversies over the justification of interventional treatments in all patients with

stable CHD and the different strategies to treat patients with NSTE-ACS underline the

need to perform such analyses. In the present study, patients with SA accounted for




treatment18

. In our study, in comparison to the other groups, patients with SA were

older and had a higher frequency of past MI as well as a history of previous

revascularization procedures. The in-hospital mortality rate for patients with SA was

0.5%, which proves the high efficacy and safety of the interventional treatment; the

mortality rate at the 29-month follow-up was also low (6%).

A reduction in mortality rate is confirmed in patients with STEMI treated with

urgent PCI. In our study, 520 patients with STEMI received delayed PCI, 63% of

whom had occluded infarct-related arteries. It is worth noting that current guidelines

recommend not performing delayed PCI on a totally occluded infarct-related artery 24

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hours after STEMI in asymptomatic patients with 1- or 2-vessel disease if they are

hemodynamically and electrically stable and show no evidence of severe ischemia19

.

Our data were collected before this guideline was published; therefore, the data were

not further classified into different clinical conditions. Far fewer deaths occurred

during hospitalization and the follow-up in the delayed PCI group than in the urgent

PCI group; however, the mortality rates in both group markedly increased during the

follow-up. In contrast to a previously published study20

, in which all patients with

NSTE-ACS received early interventional treatment after confirming that they had

ACS (within 24 hours of hospital admission), only high-risk patients received early

intervention in the present study. Similar to a previous study20

, the mortality rate of

the NSTE-ACS group significantly increased from 0.5% during hospitalization to

7.2% during the 29-month follow-up. These results are in line with current knowledge

of ACS15-17

, and could be associated with more complex lesions prior to PCI (Table 2).

Although mortality in the delayed PCI group was lower than in the urgent PCI group,

it increased markedly during the follow-up. The higher long-term mortality in patients

with STEMI compared to patients with NSTE-ACS observed in our study is

inconsistent with previous studies. This may be owing to the poorer systolic function

of the left ventricle and a higher frequency of renal insufficiency in the urgent PCI

and delayed PCI groups than in the NSTE-ACS and SA groups. In the present study,

both in-hospital and follow-up mortality rates were lower than those reported in a

previous study20


underwent urgent PCI (3.9% vs. 50%).

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, in-hospital mortality, MI, and MACE (death/MI)

rates were similar to those observed in our study. However, during a mean follow-up

of 4.1 years, the incidences of clinical events were higher in the multi-center registry

than in our study, especially the rates of any revascularization (PCI/CABG) and TVR.

There are several possible explanations for this. First, patients in this registry were

older and had higher frequencies of diabetes mellitus, arterial hypertension, renal

insufficiency, and a history of prior MI and previous revascularization procedures. In

addition, the proportion of patients presenting with STEMI was higher in this

previous study than in the current study. All these factors are well-known risk factors




recurrent angina, which was treated by medication, not by surgery. This might be the

main reason for the lower rates of revascularization (PCI/CABG) and TVR observed

in the current study. In addition, we must take into consideration the influence of

different ethnic groups.

There is a large variation in the incidence of sent thrombosis among previous

studies. The incidence of sent thrombosis observed in our study (0.7%) is similar to

that reported in four randomized DES trials (RAVEL, SIRIUS, C-SIRIUS, and

E-SIRIUS). These trials reported that the 4-year rate of sent thrombosis, according to

the Academic Research Consortium definitions, was 0.7% and 0.4% in patients that

received DES and BMS, respectively, when only definite and probable sent

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thrombosis were considered21-24

. However, the incidence of sent thrombosis was

much higher in other studies25-26

. Sent thrombosis is a complex multifactorial

syndrome, and the individual characteristics of patients and lesions as well as clinical

and procedural factors all contribute to its risks. Therefore, it is likely that different

baseline clinical and angiographic characteristics account for the differences observed

in previous studies.

A previous study9 demonstrated that SES is better than PES in terms of late stent


after the publication of the study. The selection of stent type was left to the surgeon’s

discretion; therefore, there may be a selection bias. The sample size was small in the

PES group, and statistically significant differences were observed in the number of

treated vessels, the number of stents per patient, the total stent length per patient, and

the stent diameter between the SES and PES groups; thus, attention should be paid to

the interpretation of the results. Nevertheless, our results are consistent with another

previous study27

.


observed in most studies assessing the long-term results of treatment28

, and may be

due to the many additional burdens that are typical of older people, which may

influence the long-term follow-up. Prior CABG and chronic total occlusion as

predictors of long-term death may be the result of more complex lesions and more

severe myocardium damage, thereby worsening long-term prognosis. Diabetes

mellitus and a low LVEF are well-known risk factors for adverse cardiovascular

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events in CHD patients.



function (LVEF < 40%), and multi-vessel disease were predictors of MACCE. All of

these factors are well-known adverse clinical factors for PCI. Previous studies have

identified other clinical variables, including diabetes mellitus, renal insufficiency,

prior MI, and cardiogenic shock, as well as angiographic variables, such as bypass

graft as target vessel, as predictors of MACCE. Our study did not find any significant

statistical differences in these variables among the groups, this may be due to the

small number of events and patients in each of these categories.

In our study, prior PCI, number of treated vessels, total length of stents implanted,

and LM lesions were predictors of the occurrence of TVR. In contrast to a previous

study11

, target vessel = coronary bypass and ostial lesions were not predictors of the

occurrence of TVR in our study. This may be due to the lower frequency of PCI with

coronary bypass graft in our study as well as the different strategies used to treat ostial

lesions.




Study limitation




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underestimated. In addition, patients received the 1st generation DES in our study, so

it did not exactly reflect current real world practice and clinical outcomes. We also did

not have data on stent strut thickness and the type of stent platform used. Lastly,

echocardiography was performed in a small proportion of patients with STEMI in

urgent PCI group. Therefore, this might affect the reliability of the parameter of LV

systolic function in these patients.

CONCLUSIONS


that both the early and long-term prognosis of CHD patients undergoing PCI depends

on clinical presentation as follows: 1) patients with STEMI had the worst prognosis,

while patients with stable CHD had the best prognosis; 2) the mortality rate after

hospital discharge increased markedly in the NSTE-ACS group; and 3) the incidences

of cardiac death and MI were lower with SES than with PES. The most

well-recognized risk factors for death in patients with CHD are still of great

importance for the negative prognosis of patients after PCI. The main predictors of

MACCE were clinical and angiographic parameters, whereas the predictors of TVR

were angiographic and interventional parameters.





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manuscript. TWS conceived the study, participated in its design and interpretation,

helped to draft the manuscript, and provided feedback on the manuscript. All authors



Foundation of China (Grant No. 81370364), The program for Science and Technology

Innovation of the Henan Province (NO.201203035), an Innovative Investigators

Project Grant from the Health Bureau of the Henan Province, a Program Grant for

Science & Technology Innovation Talents in Universities of the Henan Province

(2012HASTIT001), the Henan Provincial Science and Technology Achievement

Transformation Project (122102310581), the Henan Province of Medical Scientific

Province & Ministry Research Project (201301005), and the Henan Province of

Medical Scientific Research Project (201203027), China.

Contibutorship Statement: HMY participated in the coordination of the study, study

design, provided interpretation of study results and drafted the manuscript. HMY and

YDW and XJZ participated in the study design, performed the analysis and provided

interpretation of study results. DLS and JYZ and LL contributed to the study design

and interpretation of study results. LSZ and TWS contributed to the study design and

provided feedback on the manuscript. TWS conceived of the study, participated in its

design and interpretation, helped draft the manuscript and provided feedback on the

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manuscript. All authors read and approved the final manuscript.


Ethics approval: The ethics committee of The First Affiliated Hospital of Zhengzhou

University.

Provenance and peer review: Not commissioned; externally peer reviewed.

Data sharing statement: No additional data are available.

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REFERENCES



41:184–189




Circulation 2001; 103:192–195










Circulation 2003; 107:517–52



349:1315–1323

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370:937–948.




J 2006; 152:1146–1152.




101:709-16.







114:c173-7.

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1:211-7.




80:40-4.








Med 2007; 356:1503-16.




e362-425.




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2011; 56: 222-230.






Cardiol 2007; 50:1299-304.
















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Urgent PCI

(n=99)

Delayed PCI

(520)

NSTE-ACS

(1,496)

SA

(n=418)

Total

（（（（n=2,533））））

P-value

Age (years) 58±12.6 57.9±11.5 60.5±10.8 61±10.9 59.9±11.1 < 0.001

Male gender, n (%) 79(80.6) 397(76.2) 948(63.3) 301(71.8) 1,723(68) < 0.001

BMI (kg/m2) 22.5±3.95 22.9±4.03 24.3±3.6 24.1±3.6 23.9±3.8 < 0.001

Systolic BP (mmHg) 98.9±26.7 99.2±28.5 103.6±28.4 109.4±30.2 103.3±28.8 < 0.001


Prior PCI, n (%) 3(3) 13(2.5) 116(7.8) 40(9.5) 172(6.8) < 0.001

Prior CABG, n (%) 0(0) 0(0) 18(1.2) 3(0.7) 21(0.8) 0.05

OMI, n (%) 2(2) 14(2.7) 70(4.7) 149(35.6) 235(9.3) < 0.001

PVD, n (%) 0(0) 1(0.2) 2(0.1) 3(0.7) 6(0.2) 0.169

LVEF (%) 59.2±6.63 57.4±8.14 62.5±6.38 59.4±8.58 60.9±7.45 < 0.001

LVEF ≤ 40%, n (%) 0(0) 10 (2.9) 12 (1.2) 15 (6.3) 37 (2.3) < 0.001

Risk factors, n (%)

Hypertension 39(39.4) 217(41.7) 826(55.2) 164(39.2) 1,249(49.2) < 0.001


Dyslipidemia 57(58.3) 321(61.8) 800(53.5) 201(48.1) 1,379(54.4) < 0.001

Current smoker 38(38.4) 180(34.5) 373(25) 80(19.1) 671(26.5) < 0.001



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TC (mmol/L) 4.47±0.99 4.13±0.12 4.31±1.08 4.18±1.05 4.26±1.06 0.92

TG (mmol/L) 1.73±0.89 1.78±1.04 1.99±1.48 1.81±1.1 1.91±135 0.162

LDL-C (mmol/L) 2.99±0.99 2.59±0.87 2.7±0.95 2.59±0.91 2.67±0.94 0.177

HDL-C (mmol/L) 1.04±0.26 0.99±0.29 1.09±0.33 1.05±0.31 1.06±0.32 0.001

Glycemia (mmol/L) 7.97±3.5 6.61±5.17 5.78±2.14 5.8±2.15 6.05±3.15 < 0.001

BMI: body mass index; BP: blood pressure; CABG: coronary artery bypass graft; HDL-C: high

density lipoprotein cholesterol; LDL-C: low density lipoprotein cholesterol; LVEF: left ventricular

ejection fraction; NSTE-ACS: non-ST elevation acute coronary syndromes; OMI: old myocardial

infarction; PCI: percutaneous coronary intervention; PVD: peripheral vascular disease; SA: stable

angina; TC: total cholesterol; TG: triglyceride.


presentation.

Urgent PCI

(n=99)

Delayed PCI

(520)

NSTE-ACS

(1,496)

SA

(n=418)

Total

（（（（n=2,533））））

P value

Radial artery access, n (%) 97(98) 511(98.1) 1,458(97.5) 403(96.4) 2,469(97.5) 0.421

Number of diseased vessels,

n (%)

1-vessel disease 37(37.4) 196(37.6) 614(41.1) 143(34.2) 990(39.1) 0.065

2-vessel disease 42(42.4) 197(37.8) 528(35.3) 162(38.8) 929(36.7) 0.3

3-vessel disease 20(20.2) 128(24.6) 348(23.3) 110(26.3) 606(23.9) 0.47

Type B2/C lesiona, n (%) 89(52.7) 593(60.1) 1,744(64.1) 540(66.1) 2,976(63.2) 0.001

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Total chronic occlusions,

n (%)

9(9.1) 35(6.7) 135(90 47(11.2) 226(8.9) 0.116

Ostial lesions, n (%) 8(8.1) 64(12.3) 154(10.3) 49(11.7) 275(10.9) 0.443

Restenotic lesions, n (%) 1(10) 4(0.8) 21(1.4) 8(1.9) 34(1.3) 0.483

Number of treated vessels 1.36±0.59 1.55±0.67 1.5±0.66 1.57±0.7 1.52±0.67 0.12

Location of target lesions,

n (%)

Left main stem 1(1) 15(2.9) 45(3) 14(3.3) 75(3) 0.67

LAD 63(63.6) 405(77.7) 1,037(69.4) 314(75.1) 1,819(71.8) <0.001

LCX 28(28.3) 175(33.6) 573(38.3) 164(39.2) 940(37.1) 0.05

RCA 43(43.4) 216(41.5) 596(39.9) 167(40) 1,022(40.3) 0.842


Number of stents per patient 2.04±1.43 2.21±1.23 2.12±1.24 2.26±1.3 2.16±1.26 0.452

Total stent length per patient 45.5±29.1 51.9±32.1 48.9±32.4 53.4±34.6 50.1±32.6 0.267

Stent diameter (mm) 3.11±0.45 3.07±0.42 3.08±0.44 3.05±0.42 3.07±0.43 0.363


acute coronary syndromes; PCI: percutaneous coronary intervention; RCA: right coronary artery;

SA: stable angina.

a: Type B2/C, the morphology of the lesion in coronary angiography was classified according to

the criteria of The American College of Cardiology/American Heart Association.

Table 3. Clinical events according to clinical presentation.

Urgent PCI Delayed PCI NSTE-ACS SA Total P-value

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(n=99) (520) (1,496) (n=418) （（（（n=2,533））））

In-hospital events, n (%)

Death 4(4.0) 5(1.0) 7(0.5) 2(0.5) 18(0.7) <0.001

Any MI 0(0) 4(0.8) 7(0.5) 4(1.0) 15(0.6) 0.635

MACE 4(4.0) 9(1.8) 14(1.0) 6(1.5) 33(1.3) 0.001

Follow-up (cumulated events),

n (%)

Death 12(12.1) 40(7.7) 108(7.2) 25(6.0) 185(7.3) 0.104

Nonfatal MI 6(6.0) 24(4.6) 66(4.4) 12(2.9) 108(4.3) 0.414

Nonfatal stroke 2(2.0) 9(1.7) 17(1.1) 10(2.4) 38(1.5) 0.267

MACCE 21(21.2) 69(13.3) 203(13.6) 49(11.7) 342(13.5) 0.069


(PCI/CABG)

6(6.1) 36(6.9) 125(8.4) 33(7.9) 200(7.9) 0.632

TVR 2(2.0) 15(2.9) 79(5.3) 26(6.2) 12(4.8) 0.037



Stent thrombosis

(definite/probable)

1(1.0) 4(0.8) 9(0.6) 4(1.0) 15(0.7) 0.859


CABG: coronary artery bypass graft; MACCE: major adverse cardiac and cerebrovascular events

(death/myocardial infarction/stroke); MACE: major adverse cardiac events (death/myocardial

infarction); MI: myocardial infarction; NSTE-ACS: non-ST elevation acute coronary syndromes;

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PCI: percutaneous coronary intervention; SA: stable angina; TVR: target vessel revascularization.

Table 4. Baseline and procedural characteristics according to DES type.

SES

(n=1,650)

PES

(504)

Total

（（（（n=2,154））））

P-value

Age (years) 59.9±11.3 59.2±10.8 59.7±11.2 0.23

Male gender, n (%) 1,133(68.7) 336(66.8) 1,469(68.2) 0.431

BMI (kg/m2) 22.7±8.2 22.9±5.9 22.8±7.7 0.611

Prior PCI, n (%) 119(7.2) 35(7.0) 154(7.2) 0.847

Prior CABG, n (%) 13(0.8) 4(0.8) 17(0.8) 1.0

PVD, n (%) 5(0.3) 1(0.2) 6(0.3) 1.0

LVEF (%) 61.05±7.33 60.85±7.9 61.0±6.4 0.687

Hypertension, n (%) 808(49) 229(45.5) 1,037(48.2) 0.176

Diabetes mellitus, n (%) 327(19.8) 99(19.7) 426(19.8) 0.937

Dyslipidemia, n (%) 583(50.2) 230(54.0) 813(51.2) 0.182

Current smoker, n (%) 534(32.4) 166(33) 700(32.5) 0.789


Number of stents per patient 2.02±1.17 1.80±1.16 1.97±1.17 0.001

Total stent length per patient 48.4±31.5 38.3±27.2 46.2±30.9 0.001

Stent diameter (mm) 3.08±0.39 3.13±0.56 3.09±0.43 0.018

BMI: body mass index; CABG: coronary artery bypass graft; DES: drug-eluting stents; LVEF: left



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Table 5. Clinical events according to DES type.

SES

(n=1,650)

PES

(504)

Total

（（（（n=2,154））））

P-value


Death 12(0.7) 4(0.8) 16(0.7) 0.879

MI 9(0.5) 4(0.8) 13(0.6) 0.53

Follow-up (cumulated events) ,

n (%)

Death 119(7.2) 39(7.7) 158(7.3) 0.692

Cardiac death 68(4.1) 39(7.7) 107(5.0) 0.002

MI 66(4.0) 33(6.5) 99(4.6) 0.032

TVR 73(4.4) 33 (6.5) 106(4.9) 0.054


(PCI/CABG)

119(7.2) 51(10.1) 170(7.9) 0.034


Stent thrombosis

(definite/probable)

9(0.5) 4(0.8) 13(0.6) 0.744

CABG: coronary artery bypass graft; DES: drug-eluting stents; MI: myocardial infarction; PCI:



Table 6. Multivariate analysis of predictors of death, MACCE, and TVR.

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CABG:

coronary

artery

bypass

graft; CI:

confidence

interval;

HR:

hazards

ratio; LM:

left main

stem;

LVEF: left

ventricular

ejection

fraction;

MACCE:

major

adverse cardiac and cerebrovascular events; PCI: percutaneous coronary intervention; TVR: target


Death

Age (years) 21.3 1.08(1.05-1.12) < 0.001

LVEF < 40% 31.4 3.28(2.16-4.98) < 0.001


Prior CABG 11.74 13.9(3.09-63) 0.001


MACCE

Age (years) 12.6 1.03(1.01-2.2) < 0.001

LVEF < 40% 9.39 2.79(1.45-5.39) 0.002




Target vessel = LM 9.38 2.79(1.45-5.39) 0.002

TVR

Prior PCI 9.84 3.01(1.51-5.98) 0.002



stents (per 10-mm length)

1.23 1.23(1.03-1.62) 0.001

LM lesion 5.78 3.06(1.23-7.64) 0.016

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vessel revascularization..

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2, Xiao-Juan Zhang

2, De-Liang Shen

1, Jin-Ying Zhang

1,


1, and Tong-Wen Sun

2








[email protected]

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Abstract






















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Article summary

Article focus




Key messages

















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University.



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INTRODUCTION










have shown a












METHODS

Study population


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Consortium 12

.







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Statistics











RESULTS






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<Table 1 near here>







<Table 2 near here>





0.001).





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<Table 3 near here>



















<Table 6 near here>

DISCUSSION

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, which




rates.

















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STEMI17







with CHD.







treatment18










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.













of ACS15-17









previous study20



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previous study27

.



, and may be






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study11




lesions.




Study limitation




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18

underestimated. In addition, patients received the 1st generation DES in our study, so

it did not exactly reflect current real world practice and clinical outcomes. We also did

not have data on stent strut thickness and the type of stent platform used. Lastly,

echocardiography was performed in a small proportion of patients with STEMI in

urgent PCI group. Therefore, this might affect the reliability of the parameter of LV

systolic function in these patients.

CONCLUSIONS















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REFERENCES



41:184–189




Circulation 2001; 103:192–195










Circulation 2003; 107:517–52

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349:1315–1323







370:937–948.




J 2006; 152:1146–1152.




101:709-16.





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114:c173-7.



1:211-7.




80:40-4.








Med 2007; 356:1503-16.




e362-425.

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2011; 56: 222-230.






Cardiol 2007; 50:1299-304.













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Urgent PCI

(n=99)

Delayed PCI

(520)

NSTE-ACS

(1,496)

SA

(n=418)

Total

（（（（n=2,533））））

P-value

Age (years) 58±12.6 57.9±11.5 60.5±10.8 61±10.9 59.9±11.1 < 0.001

Male gender, n (%) 79(80.6) 397(76.2) 948(63.3) 301(71.8) 1,723(68) < 0.001

BMI (kg/m2) 22.5±3.95 22.9±4.03 24.3±3.6 24.1±3.6 23.9±3.8 < 0.001

Systolic BP (mmHg) 98.9±26.7 99.2±28.5 103.6±28.4 109.4±30.2 103.3±28.8 < 0.001


Prior PCI, n (%) 3(3) 13(2.5) 116(7.8) 40(9.5) 172(6.8) < 0.001

Prior CABG, n (%) 0(0) 0(0) 18(1.2) 3(0.7) 21(0.8) 0.05

OMI, n (%) 2(2) 14(2.7) 70(4.7) 149(35.6) 235(9.3) < 0.001

PVD, n (%) 0(0) 1(0.2) 2(0.1) 3(0.7) 6(0.2) 0.169

LVEF (%) 59.2±6.63 57.4±8.14 62.5±6.38 59.4±8.58 60.9±7.45 < 0.001

LVEF ≤ 40%, n (%) 0(0) 10 (2.9) 12 (1.2) 15 (6.3) 37 (2.3) < 0.001

Risk factors, n (%)

Hypertension 39(39.4) 217(41.7) 826(55.2) 164(39.2) 1,249(49.2) < 0.001


Dyslipidemia 57(58.3) 321(61.8) 800(53.5) 201(48.1) 1,379(54.4) < 0.001

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Current smoker 38(38.4) 180(34.5) 373(25) 80(19.1) 671(26.5) < 0.001



TC (mmol/L) 4.47±0.99 4.13±0.12 4.31±1.08 4.18±1.05 4.26±1.06 0.92

TG (mmol/L) 1.73±0.89 1.78±1.04 1.99±1.48 1.81±1.1 1.91±135 0.162

LDL-C (mmol/L) 2.99±0.99 2.59±0.87 2.7±0.95 2.59±0.91 2.67±0.94 0.177

HDL-C (mmol/L) 1.04±0.26 0.99±0.29 1.09±0.33 1.05±0.31 1.06±0.32 0.001

Glycemia (mmol/L) 7.97±3.5 6.61±5.17 5.78±2.14 5.8±2.15 6.05±3.15 < 0.001







presentation.

Urgent PCI

(n=99)

Delayed PCI

(520)

NSTE-ACS

(1,496)

SA

(n=418)

Total

（（（（n=2,533））））

P value



n (%)

1-vessel disease 37(37.4) 196(37.6) 614(41.1) 143(34.2) 990(39.1) 0.065

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2-vessel disease 42(42.4) 197(37.8) 528(35.3) 162(38.8) 929(36.7) 0.3

3-vessel disease 20(20.2) 128(24.6) 348(23.3) 110(26.3) 606(23.9) 0.47

Type B2/C lesiona, n (%) 89(52.7) 593(60.1) 1,744(64.1) 540(66.1) 2,976(63.2) 0.001


n (%)

9(9.1) 35(6.7) 135(90 47(11.2) 226(8.9) 0.116

Ostial lesions, n (%) 8(8.1) 64(12.3) 154(10.3) 49(11.7) 275(10.9) 0.443




n (%)

Left main stem 1(1) 15(2.9) 45(3) 14(3.3) 75(3) 0.67

LAD 63(63.6) 405(77.7) 1,037(69.4) 314(75.1) 1,819(71.8) <0.001

LCX 28(28.3) 175(33.6) 573(38.3) 164(39.2) 940(37.1) 0.05

RCA 43(43.4) 216(41.5) 596(39.9) 167(40) 1,022(40.3) 0.842







SA: stable angina.


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Urgent PCI

(n=99)

Delayed PCI

(520)

NSTE-ACS

(1,496)

SA

(n=418)

Total

（（（（n=2,533））））

P-value


Death 4(4.0) 5(1.0) 7(0.5) 2(0.5) 18(0.7) <0.001

Any MI 0(0) 4(0.8) 7(0.5) 4(1.0) 15(0.6) 0.635

MACE 4(4.0) 9(1.8) 14(1.0) 6(1.5) 33(1.3) 0.001


n (%)

Death 12(12.1) 40(7.7) 108(7.2) 25(6.0) 185(7.3) 0.104

Nonfatal MI 6(6.0) 24(4.6) 66(4.4) 12(2.9) 108(4.3) 0.414

Nonfatal stroke 2(2.0) 9(1.7) 17(1.1) 10(2.4) 38(1.5) 0.267

MACCE 21(21.2) 69(13.3) 203(13.6) 49(11.7) 342(13.5) 0.069


(PCI/CABG)

6(6.1) 36(6.9) 125(8.4) 33(7.9) 200(7.9) 0.632

TVR 2(2.0) 15(2.9) 79(5.3) 26(6.2) 12(4.8) 0.037



Stent thrombosis

(definite/probable)

1(1.0) 4(0.8) 9(0.6) 4(1.0) 15(0.7) 0.859


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SES

(n=1,650)

PES

(504)

Total

（（（（n=2,154））））

P-value

Age (years) 59.9±11.3 59.2±10.8 59.7±11.2 0.23

Male gender, n (%) 1,133(68.7) 336(66.8) 1,469(68.2) 0.431

BMI (kg/m2) 22.7±8.2 22.9±5.9 22.8±7.7 0.611

Prior PCI, n (%) 119(7.2) 35(7.0) 154(7.2) 0.847

Prior CABG, n (%) 13(0.8) 4(0.8) 17(0.8) 1.0

PVD, n (%) 5(0.3) 1(0.2) 6(0.3) 1.0

LVEF (%) 61.05±7.33 60.85±7.9 61.0±6.4 0.687

Hypertension, n (%) 808(49) 229(45.5) 1,037(48.2) 0.176


Dyslipidemia, n (%) 583(50.2) 230(54.0) 813(51.2) 0.182

Current smoker, n (%) 534(32.4) 166(33) 700(32.5) 0.789





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SES

(n=1,650)

PES

(504)

Total

（（（（n=2,154））））

P-value


Death 12(0.7) 4(0.8) 16(0.7) 0.879

MI 9(0.5) 4(0.8) 13(0.6) 0.53


n (%)

Death 119(7.2) 39(7.7) 158(7.3) 0.692

Cardiac death 68(4.1) 39(7.7) 107(5.0) 0.002

MI 66(4.0) 33(6.5) 99(4.6) 0.032

TVR 73(4.4) 33 (6.5) 106(4.9) 0.054


(PCI/CABG)

119(7.2) 51(10.1) 170(7.9) 0.034


Stent thrombosis

(definite/probable)

9(0.5) 4(0.8) 13(0.6) 0.744


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Death

Age (years) 21.3 1.08(1.05-1.12) < 0.001

LVEF < 40% 31.4 3.28(2.16-4.98) < 0.001


Prior CABG 11.74 13.9(3.09-63) 0.001


MACCE

Age (years) 12.6 1.03(1.01-2.2) < 0.001

LVEF < 40% 9.39 2.79(1.45-5.39) 0.002




Target vessel = LM 9.38 2.79(1.45-5.39) 0.002

TVR

Prior PCI 9.84 3.01(1.51-5.98) 0.002




1.23 1.23(1.03-1.62) 0.001

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revascularization..

LM lesion 5.78 3.06(1.23-7.64) 0.016

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Section/Topic Item




Introduction



Methods



collection

7




applicable

7

Data sources/

measurement



7




why

8






Results

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9




confounders

10






11




Discussion


Limitations 19



19


Other information



3





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Long-term follow-up results in patients undergoing percutaneous coronary intervention (PCI) with drug-eluting

stents：：：：results from a single high-volume PCI center

Journal: BMJ Open



Date Submitted by the Author: 23-Jun-2014

Complete List of Authors: Yao, Hai-Mu; the First Affiliated Hospital of Zhengzhou University, Department of Cardiology Wan, You-Dong; the First Affiliated Hospital of Zhengzhou University, Department of Integrated ICU Zhang, Xiao-Juan; the First Affiliated Hospital of Zhengzhou University, Department of Integrated ICU Shen, De-Liang; the First Affiliated Hospital of Zhengzhou University, Department of Cardiology Zhang, Jin-Ying; the First Affiliated Hospital of Zhengzhou University,

Department of Cardiology Li, Ling; the First Affiliated Hospital of Zhengzhou University, Department of Cardiology Zhao, Luo-Sha; the First Affiliated Hospital of Zhengzhou University, Department of Cardiology Sun, Tong-Wen; the First Affiliated Hospital of Zhengzhou University, Department of Integrated ICU




Keywords: Coronary intervention < CARDIOLOGY, Myocardial infarction < CARDIOLOGY, Cardiology < INTERNAL MEDICINE, Clinical trials <

THERAPEUTICS


BMJ Open on M


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j.com/

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2, Xiao-Juan Zhang

2, De-Liang Shen

1, Jin-Ying Zhang

1,


1, and Tong-Wen Sun

2








[email protected]

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Abstract






















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Article summary

Article focus




Key messages













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INTRODUCTION










have shown a












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METHODS

Study population





















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Consortium 12

.




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Statistics











RESULTS



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<Table 1 near here>







<Table 2 near here>





0.001).


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<Table 3 near here>


















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<Table 6 near here>

DISCUSSION




, which




rates.












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STEMI17







with CHD.







treatment18






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.













of ACS15-17







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previous study20






















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In recent years, stent strut, polymer, cytotoxic drug have evolved significantly,

cytotoxic drug were mainly the derivatives of rapamycin and paclitaxel. In order to

facilitate the description, we simply divided patients into two categories: SES or PES.









previous study27

.

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, and may be


















study11




lesions.

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Study limitation




underestimated. In recent years, DES has evolved significantly. Some types of stents

have stopped production (eg., cypher ), and some new stents have been used widely

(eg., XIENCE V). So the present study did not exactly reflect current real world

practice and clinical outcomes. We also did not have data on stent strut thickness and

the type of stent platform used. Lastly, echocardiography was performed in a small

proportion of patients with STEMI in urgent PCI group. Therefore, this might affect

the reliability of the parameter of LV systolic function in these patients.

CONCLUSIONS








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Acknowledgements

The manuscript was checked and edited by Dr. Cecilia Devoto and Mrs. Judith

Hindley (Bioedit Ltd, UK).

















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University.



REFERENCES



41:184–189




Circulation 2001; 103:192–195








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Circulation 2003; 107:517–52



349:1315–1323







370:937–948.




J 2006; 152:1146–1152.




101:709-16.


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114:c173-7.



1:211-7.




80:40-4.








Med 2007; 356:1503-16.


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e362-425.




2011; 56: 222-230.






Cardiol 2007; 50:1299-304.










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Urgent PCI

(n=99)

Delayed PCI

(520)

NSTE-ACS

(1,496)

SA

(n=418)

Total

（（（（n=2,533））））

P-value

Age (years) 58±12.6 57.9±11.5 60.5±10.8 61±10.9 59.9±11.1 < 0.001

Male gender, n (%) 79(80.6) 397(76.2) 948(63.3) 301(71.8) 1,723(68) < 0.001

BMI (kg/m2) 22.5±3.95 22.9±4.03 24.3±3.6 24.1±3.6 23.9±3.8 < 0.001

Systolic BP (mmHg) 98.9±26.7 99.2±28.5 103.6±28.4 109.4±30.2 103.3±28.8 < 0.001


Prior PCI, n (%) 3(3) 13(2.5) 116(7.8) 40(9.5) 172(6.8) < 0.001

Prior CABG, n (%) 0(0) 0(0) 18(1.2) 3(0.7) 21(0.8) 0.05

OMI, n (%) 2(2) 14(2.7) 70(4.7) 149(35.6) 235(9.3) < 0.001

PVD, n (%) 0(0) 1(0.2) 2(0.1) 3(0.7) 6(0.2) 0.169

LVEF (%) 59.2±6.63 57.4±8.14 62.5±6.38 59.4±8.58 60.9±7.45 < 0.001

LVEF ≤ 40%, n (%) 0(0) 10 (2.9) 12 (1.2) 15 (6.3) 37 (2.3) < 0.001

Risk factors, n (%)

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Hypertension 39(39.4) 217(41.7) 826(55.2) 164(39.2) 1,249(49.2) < 0.001


Dyslipidemia 57(58.3) 321(61.8) 800(53.5) 201(48.1) 1,379(54.4) < 0.001

Current smoker 38(38.4) 180(34.5) 373(25) 80(19.1) 671(26.5) < 0.001



TC (mmol/L) 4.47±0.99 4.13±0.12 4.31±1.08 4.18±1.05 4.26±1.06 0.92

TG (mmol/L) 1.73±0.89 1.78±1.04 1.99±1.48 1.81±1.1 1.91±135 0.162

LDL-C (mmol/L) 2.99±0.99 2.59±0.87 2.7±0.95 2.59±0.91 2.67±0.94 0.177

HDL-C (mmol/L) 1.04±0.26 0.99±0.29 1.09±0.33 1.05±0.31 1.06±0.32 0.001

Glycemia (mmol/L) 7.97±3.5 6.61±5.17 5.78±2.14 5.8±2.15 6.05±3.15 < 0.001







presentation.

Urgent PCI

(n=99)

Delayed PCI

(520)

NSTE-ACS

(1,496)

SA

(n=418)

Total

（（（（n=2,533））））

P value

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n (%)

1-vessel disease 37(37.4) 196(37.6) 614(41.1) 143(34.2) 990(39.1) 0.065

2-vessel disease 42(42.4) 197(37.8) 528(35.3) 162(38.8) 929(36.7) 0.3

3-vessel disease 20(20.2) 128(24.6) 348(23.3) 110(26.3) 606(23.9) 0.47

Type B2/C lesiona, n (%) 89(52.7) 593(60.1) 1,744(64.1) 540(66.1) 2,976(63.2) 0.001


n (%)

9(9.1) 35(6.7) 135(90 47(11.2) 226(8.9) 0.116

Ostial lesions, n (%) 8(8.1) 64(12.3) 154(10.3) 49(11.7) 275(10.9) 0.443




n (%)

Left main stem 1(1) 15(2.9) 45(3) 14(3.3) 75(3) 0.67

LAD 63(63.6) 405(77.7) 1,037(69.4) 314(75.1) 1,819(71.8) <0.001

LCX 28(28.3) 175(33.6) 573(38.3) 164(39.2) 940(37.1) 0.05

RCA 43(43.4) 216(41.5) 596(39.9) 167(40) 1,022(40.3) 0.842





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SA: stable angina.




Urgent PCI

(n=99)

Delayed PCI

(520)

NSTE-ACS

(1,496)

SA

(n=418)

Total

（（（（n=2,533））））

P-value


Death 4(4.0) 5(1.0) 7(0.5) 2(0.5) 18(0.7) <0.001

Any MI 0(0) 4(0.8) 7(0.5) 4(1.0) 15(0.6) 0.635

MACE 4(4.0) 9(1.8) 14(1.0) 6(1.5) 33(1.3) 0.001


n (%)

Death 12(12.1) 40(7.7) 108(7.2) 25(6.0) 185(7.3) 0.104

Nonfatal MI 6(6.0) 24(4.6) 66(4.4) 12(2.9) 108(4.3) 0.414

Nonfatal stroke 2(2.0) 9(1.7) 17(1.1) 10(2.4) 38(1.5) 0.267

MACCE 21(21.2) 69(13.3) 203(13.6) 49(11.7) 342(13.5) 0.069


(PCI/CABG)

6(6.1) 36(6.9) 125(8.4) 33(7.9) 200(7.9) 0.632

TVR 2(2.0) 15(2.9) 79(5.3) 26(6.2) 12(4.8) 0.037


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Stent thrombosis

(definite/probable)

1(1.0) 4(0.8) 9(0.6) 4(1.0) 15(0.7) 0.859







SES

(n=1,650)

PES

(504)

Total

（（（（n=2,154））））

P-value

Age (years) 59.9±11.3 59.2±10.8 59.7±11.2 0.23

Male gender, n (%) 1,133(68.7) 336(66.8) 1,469(68.2) 0.431

BMI (kg/m2) 22.7±8.2 22.9±5.9 22.8±7.7 0.611

Prior PCI, n (%) 119(7.2) 35(7.0) 154(7.2) 0.847

Prior CABG, n (%) 13(0.8) 4(0.8) 17(0.8) 1.0

PVD, n (%) 5(0.3) 1(0.2) 6(0.3) 1.0

LVEF (%) 61.05±7.33 60.85±7.9 61.0±6.4 0.687

Hypertension, n (%) 808(49) 229(45.5) 1,037(48.2) 0.176


Dyslipidemia, n (%) 583(50.2) 230(54.0) 813(51.2) 0.182

Current smoker, n (%) 534(32.4) 166(33) 700(32.5) 0.789

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SES

(n=1,650)

PES

(504)

Total

（（（（n=2,154））））

P-value


Death 12(0.7) 4(0.8) 16(0.7) 0.879

MI 9(0.5) 4(0.8) 13(0.6) 0.53


n (%)

Death 119(7.2) 39(7.7) 158(7.3) 0.692

Cardiac death 68(4.1) 39(7.7) 107(5.0) 0.002

MI 66(4.0) 33(6.5) 99(4.6) 0.032

TVR 73(4.4) 33 (6.5) 106(4.9) 0.054


(PCI/CABG)

119(7.2) 51(10.1) 170(7.9) 0.034

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Stent thrombosis

(definite/probable)

9(0.5) 4(0.8) 13(0.6) 0.744






Death

Age (years) 21.3 1.08(1.05-1.12) < 0.001

LVEF < 40% 31.4 3.28(2.16-4.98) < 0.001


Prior CABG 11.74 13.9(3.09-63) 0.001


MACCE

Age (years) 12.6 1.03(1.01-2.2) < 0.001

LVEF < 40% 9.39 2.79(1.45-5.39) 0.002




Target vessel = LM 9.38 2.79(1.45-5.39) 0.002

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revascularization..

TVR

Prior PCI 9.84 3.01(1.51-5.98) 0.002




1.23 1.23(1.03-1.62) 0.001

LM lesion 5.78 3.06(1.23-7.64) 0.016

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2, Xiao-Juan Zhang

2, De-Liang Shen

1, Jin-Ying Zhang

1,


1, and Tong-Wen Sun

2








[email protected]

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Abstract






















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Article summary

Article focus




Key messages

















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University.



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INTRODUCTION










have shown a












METHODS

Study population


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Consortium 12

.







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Statistics











RESULTS






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<Table 1 near here>







<Table 2 near here>





0.001).





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<Table 3 near here>



















<Table 6 near here>

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DISCUSSION




, which




rates.
















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STEMI17







with CHD.







treatment18









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.













of ACS15-17









previous study20


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previous study27

.



, and may be


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study11




lesions.




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Study limitation











CONCLUSIONS











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Acknowledgements

The manuscript has been checked and edited by Dr. Cecilia Devoto and Mrs.

Judith Hindley.









REFERENCES



41:184–189




Circulation 2001; 103:192–195




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Circulation 2003; 107:517–52



349:1315–1323







370:937–948.




J 2006; 152:1146–1152.


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101:709-16.







114:c173-7.



1:211-7.




80:40-4.






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Med 2007; 356:1503-16.




e362-425.




2011; 56: 222-230.






Cardiol 2007; 50:1299-304.






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Urgent PCI

(n=99)

Delayed PCI

(520)

NSTE-ACS

(1,496)

SA

(n=418)

Total

（（（（n=2,533））））

P-value

Age (years) 58±12.6 57.9±11.5 60.5±10.8 61±10.9 59.9±11.1 < 0.001

Male gender, n (%) 79(80.6) 397(76.2) 948(63.3) 301(71.8) 1,723(68) < 0.001

BMI (kg/m2) 22.5±3.95 22.9±4.03 24.3±3.6 24.1±3.6 23.9±3.8 < 0.001

Systolic BP (mmHg) 98.9±26.7 99.2±28.5 103.6±28.4 109.4±30.2 103.3±28.8 < 0.001


Prior PCI, n (%) 3(3) 13(2.5) 116(7.8) 40(9.5) 172(6.8) < 0.001

Prior CABG, n (%) 0(0) 0(0) 18(1.2) 3(0.7) 21(0.8) 0.05

OMI, n (%) 2(2) 14(2.7) 70(4.7) 149(35.6) 235(9.3) < 0.001

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PVD, n (%) 0(0) 1(0.2) 2(0.1) 3(0.7) 6(0.2) 0.169

LVEF (%) 59.2±6.63 57.4±8.14 62.5±6.38 59.4±8.58 60.9±7.45 < 0.001

LVEF ≤ 40%, n (%) 0(0) 10 (2.9) 12 (1.2) 15 (6.3) 37 (2.3) < 0.001

Risk factors, n (%)

Hypertension 39(39.4) 217(41.7) 826(55.2) 164(39.2) 1,249(49.2) < 0.001


Dyslipidemia 57(58.3) 321(61.8) 800(53.5) 201(48.1) 1,379(54.4) < 0.001

Current smoker 38(38.4) 180(34.5) 373(25) 80(19.1) 671(26.5) < 0.001



TC (mmol/L) 4.47±0.99 4.13±0.12 4.31±1.08 4.18±1.05 4.26±1.06 0.92

TG (mmol/L) 1.73±0.89 1.78±1.04 1.99±1.48 1.81±1.1 1.91±135 0.162

LDL-C (mmol/L) 2.99±0.99 2.59±0.87 2.7±0.95 2.59±0.91 2.67±0.94 0.177

HDL-C (mmol/L) 1.04±0.26 0.99±0.29 1.09±0.33 1.05±0.31 1.06±0.32 0.001

Glycemia (mmol/L) 7.97±3.5 6.61±5.17 5.78±2.14 5.8±2.15 6.05±3.15 < 0.001






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presentation.

Urgent PCI

(n=99)

Delayed PCI

(520)

NSTE-ACS

(1,496)

SA

(n=418)

Total

（（（（n=2,533））））

P value



n (%)

1-vessel disease 37(37.4) 196(37.6) 614(41.1) 143(34.2) 990(39.1) 0.065

2-vessel disease 42(42.4) 197(37.8) 528(35.3) 162(38.8) 929(36.7) 0.3

3-vessel disease 20(20.2) 128(24.6) 348(23.3) 110(26.3) 606(23.9) 0.47

Type B2/C lesiona, n (%) 89(52.7) 593(60.1) 1,744(64.1) 540(66.1) 2,976(63.2) 0.001


n (%)

9(9.1) 35(6.7) 135(90 47(11.2) 226(8.9) 0.116

Ostial lesions, n (%) 8(8.1) 64(12.3) 154(10.3) 49(11.7) 275(10.9) 0.443




n (%)

Left main stem 1(1) 15(2.9) 45(3) 14(3.3) 75(3) 0.67

LAD 63(63.6) 405(77.7) 1,037(69.4) 314(75.1) 1,819(71.8) <0.001

LCX 28(28.3) 175(33.6) 573(38.3) 164(39.2) 940(37.1) 0.05

RCA 43(43.4) 216(41.5) 596(39.9) 167(40) 1,022(40.3) 0.842

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SA: stable angina.




Urgent PCI

(n=99)

Delayed PCI

(520)

NSTE-ACS

(1,496)

SA

(n=418)

Total

（（（（n=2,533））））

P-value


Death 4(4.0) 5(1.0) 7(0.5) 2(0.5) 18(0.7) <0.001

Any MI 0(0) 4(0.8) 7(0.5) 4(1.0) 15(0.6) 0.635

MACE 4(4.0) 9(1.8) 14(1.0) 6(1.5) 33(1.3) 0.001


n (%)

Death 12(12.1) 40(7.7) 108(7.2) 25(6.0) 185(7.3) 0.104

Nonfatal MI 6(6.0) 24(4.6) 66(4.4) 12(2.9) 108(4.3) 0.414

Nonfatal stroke 2(2.0) 9(1.7) 17(1.1) 10(2.4) 38(1.5) 0.267

MACCE 21(21.2) 69(13.3) 203(13.6) 49(11.7) 342(13.5) 0.069

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(PCI/CABG)

6(6.1) 36(6.9) 125(8.4) 33(7.9) 200(7.9) 0.632

TVR 2(2.0) 15(2.9) 79(5.3) 26(6.2) 12(4.8) 0.037



Stent thrombosis

(definite/probable)

1(1.0) 4(0.8) 9(0.6) 4(1.0) 15(0.7) 0.859







SES

(n=1,650)

PES

(504)

Total

（（（（n=2,154））））

P-value

Age (years) 59.9±11.3 59.2±10.8 59.7±11.2 0.23

Male gender, n (%) 1,133(68.7) 336(66.8) 1,469(68.2) 0.431

BMI (kg/m2) 22.7±8.2 22.9±5.9 22.8±7.7 0.611

Prior PCI, n (%) 119(7.2) 35(7.0) 154(7.2) 0.847

Prior CABG, n (%) 13(0.8) 4(0.8) 17(0.8) 1.0

PVD, n (%) 5(0.3) 1(0.2) 6(0.3) 1.0

LVEF (%) 61.05±7.33 60.85±7.9 61.0±6.4 0.687

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Hypertension, n (%) 808(49) 229(45.5) 1,037(48.2) 0.176


Dyslipidemia, n (%) 583(50.2) 230(54.0) 813(51.2) 0.182

Current smoker, n (%) 534(32.4) 166(33) 700(32.5) 0.789









SES

(n=1,650)

PES

(504)

Total

（（（（n=2,154））））

P-value


Death 12(0.7) 4(0.8) 16(0.7) 0.879

MI 9(0.5) 4(0.8) 13(0.6) 0.53


n (%)

Death 119(7.2) 39(7.7) 158(7.3) 0.692

Cardiac death 68(4.1) 39(7.7) 107(5.0) 0.002

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MI 66(4.0) 33(6.5) 99(4.6) 0.032

TVR 73(4.4) 33 (6.5) 106(4.9) 0.054


(PCI/CABG)

119(7.2) 51(10.1) 170(7.9) 0.034


Stent thrombosis

(definite/probable)

9(0.5) 4(0.8) 13(0.6) 0.744






Death

Age (years) 21.3 1.08(1.05-1.12) < 0.001

LVEF < 40% 31.4 3.28(2.16-4.98) < 0.001


Prior CABG 11.74 13.9(3.09-63) 0.001


MACCE

Age (years) 12.6 1.03(1.01-2.2) < 0.001

LVEF < 40% 9.39 2.79(1.45-5.39) 0.002

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revascularization..




Target vessel = LM 9.38 2.79(1.45-5.39) 0.002

TVR

Prior PCI 9.84 3.01(1.51-5.98) 0.002




1.23 1.23(1.03-1.62) 0.001

LM lesion 5.78 3.06(1.23-7.64) 0.016

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Section/Topic Item




Introduction



Methods



collection

7




applicable

7

Data sources/

measurement



7




why

8






Results

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9




confounders

10






11




Discussion


Limitations 19



19


Other information



3





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1





2, Xiao-Juan Zhang

2, De-Liang Shen

1, Jin-Ying Zhang

1,


1, and Tong-Wen Sun

2








[email protected]

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2

Abstract






















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3




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4

Article summary

Article focus




Key messages

















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5








University.



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6

INTRODUCTION










have shown a












METHODS

Study population


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7























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8
















Consortium 12

.







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9






Statistics











RESULTS






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10






<Table 1 near here>







<Table 2 near here>





0.001).





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11


<Table 3 near here>



















<Table 6 near here>

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12

DISCUSSION




, which




rates.
















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13


STEMI17







with CHD.







treatment18









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14




.













of ACS15-17









previous study20


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15
























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16





















previous study27

.



, and may be


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17

















study11




lesions.




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18

Study limitation











CONCLUSIONS











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19

Acknowledgements

The manuscript was checked and edited by Dr. Cecilia Devoto and Mrs. Judith

Hindley (Bioedit Ltd, UK).









REFERENCES



41:184–189




Circulation 2001; 103:192–195




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Circulation 2003; 107:517–52



349:1315–1323







370:937–948.




J 2006; 152:1146–1152.


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101:709-16.







114:c173-7.



1:211-7.




80:40-4.






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Med 2007; 356:1503-16.




e362-425.




2011; 56: 222-230.






Cardiol 2007; 50:1299-304.






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Urgent PCI

(n=99)

Delayed PCI

(520)

NSTE-ACS

(1,496)

SA

(n=418)

Total

（（（（n=2,533））））

P-value

Age (years) 58±12.6 57.9±11.5 60.5±10.8 61±10.9 59.9±11.1 < 0.001

Male gender, n (%) 79(80.6) 397(76.2) 948(63.3) 301(71.8) 1,723(68) < 0.001

BMI (kg/m2) 22.5±3.95 22.9±4.03 24.3±3.6 24.1±3.6 23.9±3.8 < 0.001

Systolic BP (mmHg) 98.9±26.7 99.2±28.5 103.6±28.4 109.4±30.2 103.3±28.8 < 0.001


Prior PCI, n (%) 3(3) 13(2.5) 116(7.8) 40(9.5) 172(6.8) < 0.001

Prior CABG, n (%) 0(0) 0(0) 18(1.2) 3(0.7) 21(0.8) 0.05

OMI, n (%) 2(2) 14(2.7) 70(4.7) 149(35.6) 235(9.3) < 0.001

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PVD, n (%) 0(0) 1(0.2) 2(0.1) 3(0.7) 6(0.2) 0.169

LVEF (%) 59.2±6.63 57.4±8.14 62.5±6.38 59.4±8.58 60.9±7.45 < 0.001

LVEF ≤ 40%, n (%) 0(0) 10 (2.9) 12 (1.2) 15 (6.3) 37 (2.3) < 0.001

Risk factors, n (%)

Hypertension 39(39.4) 217(41.7) 826(55.2) 164(39.2) 1,249(49.2) < 0.001


Dyslipidemia 57(58.3) 321(61.8) 800(53.5) 201(48.1) 1,379(54.4) < 0.001

Current smoker 38(38.4) 180(34.5) 373(25) 80(19.1) 671(26.5) < 0.001



TC (mmol/L) 4.47±0.99 4.13±0.12 4.31±1.08 4.18±1.05 4.26±1.06 0.92

TG (mmol/L) 1.73±0.89 1.78±1.04 1.99±1.48 1.81±1.1 1.91±135 0.162

LDL-C (mmol/L) 2.99±0.99 2.59±0.87 2.7±0.95 2.59±0.91 2.67±0.94 0.177

HDL-C (mmol/L) 1.04±0.26 0.99±0.29 1.09±0.33 1.05±0.31 1.06±0.32 0.001

Glycemia (mmol/L) 7.97±3.5 6.61±5.17 5.78±2.14 5.8±2.15 6.05±3.15 < 0.001






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presentation.

Urgent PCI

(n=99)

Delayed PCI

(520)

NSTE-ACS

(1,496)

SA

(n=418)

Total

（（（（n=2,533））））

P value



n (%)

1-vessel disease 37(37.4) 196(37.6) 614(41.1) 143(34.2) 990(39.1) 0.065

2-vessel disease 42(42.4) 197(37.8) 528(35.3) 162(38.8) 929(36.7) 0.3

3-vessel disease 20(20.2) 128(24.6) 348(23.3) 110(26.3) 606(23.9) 0.47

Type B2/C lesiona, n (%) 89(52.7) 593(60.1) 1,744(64.1) 540(66.1) 2,976(63.2) 0.001


n (%)

9(9.1) 35(6.7) 135(90 47(11.2) 226(8.9) 0.116

Ostial lesions, n (%) 8(8.1) 64(12.3) 154(10.3) 49(11.7) 275(10.9) 0.443




n (%)

Left main stem 1(1) 15(2.9) 45(3) 14(3.3) 75(3) 0.67

LAD 63(63.6) 405(77.7) 1,037(69.4) 314(75.1) 1,819(71.8) <0.001

LCX 28(28.3) 175(33.6) 573(38.3) 164(39.2) 940(37.1) 0.05

RCA 43(43.4) 216(41.5) 596(39.9) 167(40) 1,022(40.3) 0.842

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SA: stable angina.




Urgent PCI

(n=99)

Delayed PCI

(520)

NSTE-ACS

(1,496)

SA

(n=418)

Total

（（（（n=2,533））））

P-value


Death 4(4.0) 5(1.0) 7(0.5) 2(0.5) 18(0.7) <0.001

Any MI 0(0) 4(0.8) 7(0.5) 4(1.0) 15(0.6) 0.635

MACE 4(4.0) 9(1.8) 14(1.0) 6(1.5) 33(1.3) 0.001


n (%)

Death 12(12.1) 40(7.7) 108(7.2) 25(6.0) 185(7.3) 0.104

Nonfatal MI 6(6.0) 24(4.6) 66(4.4) 12(2.9) 108(4.3) 0.414

Nonfatal stroke 2(2.0) 9(1.7) 17(1.1) 10(2.4) 38(1.5) 0.267

MACCE 21(21.2) 69(13.3) 203(13.6) 49(11.7) 342(13.5) 0.069

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(PCI/CABG)

6(6.1) 36(6.9) 125(8.4) 33(7.9) 200(7.9) 0.632

TVR 2(2.0) 15(2.9) 79(5.3) 26(6.2) 12(4.8) 0.037



Stent thrombosis

(definite/probable)

1(1.0) 4(0.8) 9(0.6) 4(1.0) 15(0.7) 0.859







SES

(n=1,650)

PES

(504)

Total

（（（（n=2,154））））

P-value

Age (years) 59.9±11.3 59.2±10.8 59.7±11.2 0.23

Male gender, n (%) 1,133(68.7) 336(66.8) 1,469(68.2) 0.431

BMI (kg/m2) 22.7±8.2 22.9±5.9 22.8±7.7 0.611

Prior PCI, n (%) 119(7.2) 35(7.0) 154(7.2) 0.847

Prior CABG, n (%) 13(0.8) 4(0.8) 17(0.8) 1.0

PVD, n (%) 5(0.3) 1(0.2) 6(0.3) 1.0

LVEF (%) 61.05±7.33 60.85±7.9 61.0±6.4 0.687

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Hypertension, n (%) 808(49) 229(45.5) 1,037(48.2) 0.176


Dyslipidemia, n (%) 583(50.2) 230(54.0) 813(51.2) 0.182

Current smoker, n (%) 534(32.4) 166(33) 700(32.5) 0.789









SES

(n=1,650)

PES

(504)

Total

（（（（n=2,154））））

P-value


Death 12(0.7) 4(0.8) 16(0.7) 0.879

MI 9(0.5) 4(0.8) 13(0.6) 0.53


n (%)

Death 119(7.2) 39(7.7) 158(7.3) 0.692

Cardiac death 68(4.1) 39(7.7) 107(5.0) 0.002

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MI 66(4.0) 33(6.5) 99(4.6) 0.032

TVR 73(4.4) 33 (6.5) 106(4.9) 0.054


(PCI/CABG)

119(7.2) 51(10.1) 170(7.9) 0.034


Stent thrombosis

(definite/probable)

9(0.5) 4(0.8) 13(0.6) 0.744






Death

Age (years) 21.3 1.08(1.05-1.12) < 0.001

LVEF < 40% 31.4 3.28(2.16-4.98) < 0.001


Prior CABG 11.74 13.9(3.09-63) 0.001


MACCE

Age (years) 12.6 1.03(1.01-2.2) < 0.001

LVEF < 40% 9.39 2.79(1.45-5.39) 0.002

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revascularization..




Target vessel = LM 9.38 2.79(1.45-5.39) 0.002

TVR

Prior PCI 9.84 3.01(1.51-5.98) 0.002




1.23 1.23(1.03-1.62) 0.001

LM lesion 5.78 3.06(1.23-7.64) 0.016

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