Myeong-Ki Hong , MD. Ph D, on behalf of RESET investigators Professor, Division of Cardiology,
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Transcript of Myeong-Ki Hong , MD. Ph D, on behalf of RESET investigators Professor, Division of Cardiology,
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Myeong-Ki Hong, MD. Ph D, on behalf of RESET investigators
Professor, Division of Cardiology, Severance Cardiovascular Hospital
Yonsei University College of Medicine, Seoul, Korea
A New Strategy for Discontinuation of Dual Antiplatelet Therapy: Real Safety and Efficacy of 3-Month Dual Antiplatelet Therapy Following Zotarolimus-Eluting Stent Implantation: RESET Trial
RESET ClinicalTrials.gov identifier: NCT01145079
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Funding sourcesSupported by the Cardiovascular Research Center, Seoul, Korea, Medtronic Inc. and grants from the Korea Healthcare Technology R&D Project, Ministry for Health, Welfare & Family Affairs, Republic of Korea (No. A085012 and A102064), the Korea Health 21 R&D Project, Ministry of Health & Welfare, Republic of Korea (No. A085136).
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Background - I• Because one of strong predictor for stent thrombosis is early
discontinuation of clopidogrel, prolonged dual antiplatelet therapy (DAPT) is highly recommended.
• However, prolonged use of clopidogrel is associated with many potential risks; bleeding, higher cost, and poor patient compliance or premature discontinuation.
• Reports from several trials of the Endeavor zotarolimus-eluting stent (E-ZES) have shown beneficial efficacy and safety, despite a relatively short duration of DAPT.
Iakovou I, et al. JAMA 2005;293:2126-30.Pfisterer M, et al. J Am Coll Cardiol 2006;48:2584-91.
Brar SS, et al. J Am Coll Cardiol 2008;51:2220-7.
Bhatt DL, et al. N Engl J Med 2006;354:1706-17.Grines CL, et al. Circulation 2007;115:813-8.
Stone GW, et al. Am J Cardiol 2008;102:1017-22.
Fajadet J, et al. Circulation 2006;114:798-806. Meredith IT, et al. Am J Cardiol. 2007;100:S56-S61.Leon MB, et al. J Am Coll Cardiol 2010;55:543-54.
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Background - IIKim JS, et al. J Am Coll Cardiol Intv 2009;2:1240-7.
Recent OCT study reported sufficient strut coverage following E-ZES implantation as early as 3 months post-procedure.
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Background - III
Hahn JY, et al. Circ J 2010;74:2314-21.
A recent registry study reported that low-risk patients with E-ZES + 3-month DAPT (n=661) showed a favorable long-term clinical outcomes after cessation of clopidogrel 3 months post intervention.
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Hypothesis & ObjectiveHypothesis;
Three-month DAPT after E-ZES implantation (E-ZES+3-month DAPT) may be non-inferior to 12-month DAPT after implantation with other DES (standard therapy).
Objectives;To compare the safety and efficacy between patients treated with E-ZES+3-month DAPT and patients treated with the standard therapy, in the RESET (REal Safety and Efficacy of a 3-month dual antiplatelet Therapy following E-ZES implantation) trial.
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Randomization• Using an interactive web-based response system, study
participants were randomly assigned in a 1:1 ratio to receive either the E-ZES or another currently available DES.
• Stratified by participating center and four clinical or lesion characteristics;
Study design and patients • Prospective, open label, randomized trial • Participating centers; conducted at 26 sites in Korea
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Inclusion criteria • Patients with stable angina, unstable angina, or acute MI• Diameter stenosis ≥ 50% and reference vessel diameter of 2.5 to 4.0
mm by visual estimation• Elective PCI, eligible for participation
Exclusion criteria • Prior history of cerebral vascular accidents, peripheral artery diseases,
thromboembolic disease or stent thrombosis • Left ventricular ejection fraction < 40% • Lesions with in-stent restenotic lesion, chronic total occlusion, or
significant left main disease requiring intervention• Cardiogenic shock• Acute ST-elevation MI within 48 hours after onset of symptoms• Contraindication to antiplatelet agents• Severe hepatic (≥3 times normal values) or renal dysfunction (serum
creatinine >2.0 mg/dl)
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Primary end-points• A composite of 1) death from cardiovascular cause, 2)
myocardial infarction, 3) stent thrombosis *, 4) ischemia-driven target-vessel revascularization or 5) bleeding † at 1 year post-procedure.
* Stent thrombosis, defined as definite or probable stent thrombosis by ARC definition† Bleeding, defined as TIMI-defined major or minor bleeding
• Post-procedure clinical follow-up; in-hospital, and after 1, 3, 6 and 12 months either by clinic visit or by telephone interview
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Sample size calculation• A non-inferiority comparison
• Overall incidence of the primary endpoint of two groups; E-ZES+3-month DAPT; 10% Standard therapy; 11%
We hypothesized that the clinical outcome of E-ZES+3-month DAPT would be non-inferior to the other group with a non-inferiority margin of 4% for the absolute difference in risk at 12 months.
Assuming a 10% drop out rate, this required an estimated sample size of 2,120 patients (1,060 for each group) to achieve 80% power for non-inferiority test and a one-sided type I error of 5%.
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Statistical analysis• All comparisons, according to the intention-to-treat allocations. • Cumulative event rates, estimated by the Kaplan-Meier
method (using log-rank test) and calculated the absolute differences and 95% confidence intervals (CI).
• P-value <0.05 were considered statistically significant. • Statistical Analysis System software (SAS; 9.1.3., SAS
Institute, NC) and R version 2.12.2 (R Development Core Team, Vienna, Austria).
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Principal investigator;Professor Myeong-Ki Hong, MD, Ph D, Yonsei University College of Medicine, Seoul, Korea
Steering committee;• Myeong-Ki Hong, MD, Yonsei University College of Medicine, Seoul, Korea • Yangsoo Jang, MD, Yonsei University College of Medicine, Seoul, Korea • Joo-Young Yang, MD, National Health Insurance Corporation Ilsan Hospital, Goyang, Korea• Hyuck-Moon Kwon, MD, Kangnam Severance Hospital, Seoul, Korea• Jung-Han Yoon, MD, Yonsei University Wonju College of Medicine, Wonju, Korea• Dong-Woon Jeon, MD, National Health Insurance Corporation Ilsan Hospital, Goyang, Korea• Seung-Whan Lee, MD, Wonju Christian Hospital, Wonju, Korea• Byung-Ok Kim, MD, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Korea• Bum-Kee Hong, MD, Kangnam Severance Hospital, Seoul, Korea
Coordinating center; Cardiovascular Research Center, Seoul Korea
Data safety monitoring board (DSMB);• Chul-Min Ahn, MD, Korea University College of Medicine, Seoul, Korea• Hyuck-Jai Chang, MD, Yonsei University College of Medicine, Seoul, Korea • Seong-Hoon Choi, MD, Hallym University College of Medicine, Seoul, Korea• Deok-Kyu Cho, MD, Kwandong University College of Medicine, Goyang, Korea
Clinical event committee (CEC);• Eui-Young Choi, MD, Kangnam Severance Hospital, Seoul, Korea• Ji-Young Shim, MD, Yonsei University College of Medicine, Seoul, Korea • Se-Jung Yoon, MD, NHIC Ilsan Hospital, Koyang, Korea • Jang Young Kim, MD, Wonju Christian Hospital, Wonju, Korea
Data management and biostatistical analysis;• Jung Mo Nam, Ph D, Department of Preventive Medicine and Biostatistics, Yonsei University College of Medicine, Seoul,
Korea• Dong-Ho Shin, MD, MPH, Yonsei University College of Medicine, Seoul, Korea
Study organization
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E-ZES(n=146
)
E-ZES(n=301
)
E-ZES(n=341
)
E-ZES(n=271
)
R-ZES(n=146
)
R-ZES(n=300
)
SES(n=340
)
EES(n=272
)
Diabetes mellitus
subset (N=292)
Acute coronary syndrome
subset (N=601)
Short-length DES
Subset (N=681)Long-length DES Subset (N=543)
2,148 patients enrolled and randomized
31 patients excluded - 16 Withdrawal of consent - 15 Met exclusion criteria
Divided into 4 subsets and 1:1 randomization was performed.
E-ZES + 3-month DAPT (n=1059) Standard therapy (n=1058)
E-ZES + 3-month DAPTStandard Therapy:Other DES with 12-month DAPT
Study at a glance & Final Enrollment
R-ZES = Resolute zotarolimus-eluting stent ; SES = sirolimus-eluting stent; EES = everolimus-eluting stents
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Baseline clinical characteristicsVariables E-ZES+3-month DAPT
(n=1,059)Standard therapy
(n=1,058) P
Age (year) 62.4±9.4 62.4±9.8 0.94Male sex, n (%) 682 (64.4) 665 (62.9) 0.47Body mass index, kg/m2 25.0±3.2 24.9±3.1 0.50Hypertension, n (%) 660 (62.3) 650 (61.4) 0.69Diabetes mellitus, n (%) 316 (29.8) 305 (28.8) 0.63Dyslipidemia, n (%) 611 (57.7) 634 (59.9) 0.31Current smoker, n (%) 267 (25.2) 241 (22.8) 0.20Congestive heart failure, n (%) 120 (11.3) 125 (11.8) 0.74Ejection fraction, % 64.2±9.4 63.9±9.4 0.45Prior myocardial infarction, n (%) 19 (1.8) 17 (1.6) 0.87Prior percutaneous coronary intervention, n (%) 37 (3.5) 32 (3.0) 0.63Prior coronary bypass surgery, n (%) 2 (0.2) 6 (0.6) 0.18Clinical presentation, n (%) 0.66
Stable angina 471 (44.5) 490 (46.3) Unstable angina 432 (40.8) 422 (39.9) Acute myocardial infarction 156 (14.7) 146 (13.8)
Medications at discharge Statins, no. (%) 923 (87.2) 914 (86.4) 0.61Beta blockers, no. (%) 712 (67.2) 730 (69.0) 0.40ACE inhibitors, no. (%) 331 (31.3) 349 (33.0) 0.40Angiotensin receptor blockers, no. (%) 323 (30.5) 301 (28.4) 0.32
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Baseline angiographic characteristics
Variables E-ZES+3-month DAPT(n=1,059)
Standard therapy(n=1,058) P
No. of lesions 1341 1346 Treated vessel, LAD, n (%) 707 (52.7) 722 (53.6) 0.54ACC/AHA class B2/C C, n (%) 910 (67.9) 932 (69.2) 0.46Lesion length, mm 19.6±10.1 20.1±10.8 0.21Type of drug-eluting stent, n (%)
Endeavor zotarolimus-eluting stents 1341 (100.0) - Cypher sirolimus-eluting stents - 383 (28.5) Xience everolimus-eluting stents - 404 (30.0) Resolute zotarolimus-eluting stents - 559 (41.5)
Multi-vessel intervention / patients, n (%) 233 (22.0) 248 (23.4) 0.44Number of lesions per patient 1.27±0.53 1.27±0.68 0.88Stent diameter, mm 3.18±0.42 3.17 ± 0.83 0.63Stent length per lesion, mm 22.7±10.1 22.9±10.7 0.35Adjuvant post-dilation, n (%) 539 (40.2) 540 (40.1) 0.97Maximum stent pressure, atm 16.2±3.7 16.5±3.6 0.35Use of GP IIb/IIIa inhibitors/patient, n (%) 20 (1.9) 21 (2.0) 0.89Procedure success, no. (%) 1339 (99.9) 1345 (99.9) 0.63
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Quantitative Angiographic analysis
Variables E-ZES+3-month DAPT(n=1,059)
Standard therapy(n=1,058) P
No. of lesions 1341 1346
Pre-intervention
Reference vessel diameter, mm 3.0±0.5 3.0±0.5 0.13
Minimum luminal diameter, mm 1.1±0.5 1.0±0.5 0.23
Percent diameter stenosis, % 65.0±14.1 65.5±13.8 0.36
Post-intervention
Minimum luminal diameter, mm
In-stent 2.7±0.4 2.7±0.4 0.28
In-segment 2.2±0.5 2.1±0.5 0.58
Percent diameter stenosis, %
In-stent 11.2±7.8 11.1±8.1 0.65
In-segment 30.7±11.7 30.7±11.7 0.83
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Clinical follow-up at 1 year
• Clinical follow-up at 1 year was completed for 2,086 of 2,117 patients (98.5%):
1,044 of 1,059 patients (98.6%) in E-ZES+3-month DAPT vs. 1,042 of 1,058 patients (98.5%) in standard therapy group (p=0.99).
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Primary endpoint, by Kaplan-Meier method
No. at Risk E-ZES +3-month
DAPT 1059 1049 1037 1027 945
Standard therapy 1058 1046 1032 1024 920
* Primary end-point; A composite of death from CV cause, MI, stent thrombosis, TVR or bleeding at 1 year
0
2
8
6
4
Cum
ulat
ive
even
t rat
e (%
)
0 6 12
Standard therapyE-ZES + 3-month DAPT
4.7%
p-value for non-inferiority < 0.01
Months
Difference = 0.0% 95% CI, -2.5 to 2.5; p = 0.84
4.7%
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Any death, MI, or stent thrombosis
0
2
8
6
4
Cum
ulat
ive
even
t rat
e (%
)
0 6 12
Standard therapyE-ZES + 3-month DAPT
1.3%
0.8%
p-value by log-rank test = 0.48
MonthsNo. at Risk
E-ZES+ 3-month DAPT 1059 1051 1045 1041 966
Standard therapy 1058 1051 1042 1037 937
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Individual component of primary endpoint (ITT)
Variables E-ZES+3-month DAPT (n=1,059)
Standard therapy(n=1,058)
Difference(95% CI) p
Death, n (%)
From any cause 5 (0.5) 8 (1.0) -0.5% (-1.4 – 0.4) 0.39
From cardiovascular cause 2 (0.2) 4 (0.4) -0.2% (-0.6 – 0.3) 0.41
MI, n (%) 2 (0.2) 4 (0.4) -0.2% (-0.7 ~ 0.3) 0.41
TVR, n (%) 31 (3.9) 27 (3.7) 0.2% (-2.3 – 2.6) 0.70
Non-TVR, n (%) 15 (1.5) 11 (1.5) 0.0% (-1.3 – 1.4) 0.52
Stent thrombosis, n (%) 2 (0.2) 3 (0.3) -0.1% (-0.5 – 0.3) 0.65
< 1months 2 0
1-3 months 0 0
3-12 months 0 3
Bleeding, n (%)
Major or minor 5 (0.5) 10 (1.0) -0.5% (-1.2 – 0.2) 0.20
Major 2 (0.2) 6 (0.6) -0.4% (-0.9 – 0.1) 0.16
CVA, n (%) 6 (0.6) 6 (0.7) 0.1% (-0.1 – 1.0) 0.96
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Subgroup analysis
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Duration of dual antiplatelet therapy • Mean duration of DAPT;
- E-ZES+3-month DAPT group: 93±28 days (median, 93 day) - Standard therapy group: 364±31 days (median, 363 day)
• Interruption of DAPT regimen in E-ZES + 3-month DAPT group occurred in 62 / 1,059 patients (5.9%) (mean duration of
DAPT, 196±63 days; median, 173 day for the 62 patients).
• Reasons for interruption of the DAPT regimen; physicians’ mistake or failure of monitoring (n=26) physicians’ discretion (n=22) patients’ disagreement (n=13) repeat revascularization (n=1)
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Clinical outcomes of both groups, *per protocol analysisCharacteristics E-ZES+3-month
DAPT (n=997)Standard therapy
(n=1,058)Difference(95% CI) p
Primary endpoint, n (%) 36 (4.6) 41 (4.7) -0.1% (-2.7–2.4) 0.69Any death, MI, or ST, n (%) 6 (0.6) 11 (1.3) -0.7% (-1.6–0.3) 0.27CV Death or MI, n (%) 4 (0.4) 7 (0.7) -0.3% (-0.9–0.4) 0.42Each components Death, n (%) From any cause 3 (0.3) 8 (1.0) -0.7% (-1.5–0.2) 0.15 From cardiovascular cause 2 (0.2) 4 (0.4) -0.2% (-0.6–0.3) 0.46MI, n (%) 2 (0.2) 4 (0.4) -0.2% (-0.7–0.3) 0.46TVR, n (%) 27 (3.7) 27 (3.7) 0.0% (-2.5–2.4) 0.94Non-TVR, n (%) 14 (1.5) 11 (1.5) 0.0% (-1.4–1.4) 0.55Stent thrombosis, n (%) 2 (0.2) 3 (0.3) -0.1% (-0.5–0.3) 0.70
< 1months 2 0 1-3 months 0 0 3-12 months 0 3
Bleeding, n (%) Major or minor 5 (0.5) 10 (1.0) -0.5% (-1.2–0.3) 0.24Major 2 (0.2) 6 (0.6) -0.4% (-0.9–0.2) 0.18
CVA, n (%) 5 (0.5) 6 (0.7) -0.2% (-0.9–0.6) 0.80
* Analysis after exclusion of the patients with interrupting 3-month DAPT
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Summary• E-ZES+3-month DAPT was non-inferior to the standard
therapy for the primary endpoint (defined as a composite of death from CV cause, MI, stent thrombosis, TVR or bleeding at 1 year).
• The occurrence of stent thrombosis was similar between the two groups: From 3 months through 12 months following the index procedure, there were no stent thrombosis events in the E-ZES+3-month DAPT group.
• There were no significant difference of the other composite events or individual component of primary endpoint.
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Limitations• One year of clinical follow-up may not be sufficient to assess
the fatal late outcomes (e.g, very late stent thrombosis).
• Because the patients with very high risks were not included, the generalized application of these results to the entire population demands careful attention.
• The comparator group was not treated with a single DES type.
• There was no 3-month vs. 12-month DAPT either within E-ZES or within other DES. - However, hypothesis of protection by E-ZES was the main
objective of this trial and the 1:1 matched randomization between E-ZES and the comparative DES was performed.
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Conclusion
• E-ZES + 3-month DAPT could be safe and beneficial for the selected patients with coronary artery disease who may need to stop DAPT early after DES implantation.
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Clinical implications• As an alternative PCI strategy, E-ZES + 3-month
DAPT could be useful for the selected patients, • those at risk for bleeding complications • those at risk of poor compliance with
medication, especially in the elderly population
• those with a high probability of unexpected non-cardiac surgery or invasive procedures
• those with a low risk of stent thrombosis