Hyo-Soo Kim, MD/PhD Kyung-Woo Park, Si-Hyuck Kang, Kwang-Soo Cha,
description
Transcript of Hyo-Soo Kim, MD/PhD Kyung-Woo Park, Si-Hyuck Kang, Kwang-Soo Cha,
Randomized Comparison of Randomized Comparison of PtCr-EES PtCr-EES vs vs CoCr-ZESCoCr-ZES
in All-Comers Receiving PCIin All-Comers Receiving PCI
The HOST-ASSURE Randomized Trial The HOST-ASSURE Randomized Trial
Hyo-Soo Kim, MD/PhDKyung-Woo Park, Si-Hyuck Kang, Kwang-Soo Cha,
Byoung-Eun Park, Jay-Young Rhew, Hui-Kyung Jeon, In-Ho Chae
On Behalf of The HOST-ASSURE Trial Investigators
Seoul National University Hospital, Seoul, Korea
DisclosuresDisclosures
Kim HS reports receiving honorarium for
lectures and research grants from Boston
Scientific and Medtronic.
BackgroundBackground
• Second-generation DES have improved clinical outcome compared
with first-generation DES.
• Resolute (Medtronic, Minneapolis, MN, USA) is a CoCr-based
zotarolimus-eluting stent (CoCr-ZES) that showed equivalent
outcome to Xience (CoCr-based everolimus-eluting stent).
• Promus Element (Boston Scientific, Natick, MA, USA) is a PtCr-
based EES (PtCr-EES) that has limited clinical data regarding the
efficacy and safety.
• No study to compare Promus-Element vs. Resolute.
• No data on the real picture of longitudinal stent deformation
(LSD) in these newer generation DES based on the systemic review
of angiographs in the prospectively-collected cohort.
ObjectivesObjectives
[Hypothesis]
PtCr-EESPtCr-EES is Non-Inferior to CoCr-ZESCoCr-ZESRegarding Target Lesion Failure at 12 month
vs.
PtCr-EES (Promus-Element)
PtCr-EES (Promus-Element)
CoCr-ZES(Resolute)CoCr-ZES(Resolute)
Longitudinal Stent Deformation (LSD) : Longitudinal Stent Deformation (LSD) : a trade-off of thin struta trade-off of thin strut
How often does it happen? How often does it happen? Under what conditions does it occur? Under what conditions does it occur? How severe can it be? How severe can it be?
Study DesignStudy Design
PtCr-EES arm(N=2,500)
CoCr-ZES arm(N=1,250)
3,750 All Comers Receiving PCI3,750 All Comers Receiving PCI3,750 All Comers Receiving PCI3,750 All Comers Receiving PCI
Percutaneous Coronary InterventionPercutaneous Coronary Intervention
Coronary AngiographyCoronary Angiography
Target Lesion Failure at 12 Months Post-PCI (Intention-To-Treat Analysis)Target Lesion Failure at 12 Months Post-PCI (Intention-To-Treat Analysis)
2:1 Randomization
40 Centers in Korea
Prospective, single-blinded, randomized multi-center trial
Enrollment CriteriaEnrollment Criteria
General Inclusion Criteria
Angiographic Inclusion Criteria
Exclusion Criteria
• Age ≥18 years• Ability to verbally confirm understandings
of risks, benefits and treatment alternatives with written informed consent prior to any study-related procedure
• Significant lesion (>50% by visual estimate) in any of the coronary arteries, venous or arterial bypass grafts
• Evidence of myocardial ischemiaor diameter stenosis > 70%
• Target lesion in coronary artery, venous or arterial bypass graft with diameter of ≥ 2.5 mm and ≤ 4.25 mm
• Target lesion amenable for PCI
• LVEF <25% or cardiogenic shock • Symptomatic heart failure• Life expectancy <1 year• History of bleeding diathesis, known
coagulopathy (including HIT), abnormal CBC (Hb < 10 g/dL or PLT < 100k /μL) or refusal of blood transfusions
• GI or GU bleeding ≤ 3 monthsor major surgery ≤ 2 months
• Known hypersensitivity/contraindication to heparin, aspirin, clopidogrel, cilostazol, everolimus, zotarolimus, or contrast media
• Systemic (intravenous) Everolimus or Zotarolimus use ≤ 12 months
• Female of childbearing potential• Actively participating in another drug or
device investigational study
Study EndpointsStudy Endpoints• Primary Endpoint: Target Lesion Failure at 12 Month Target Lesion Failure at 12 Month
(a composite of cardiac death, TV-related MI, and ischemia-driven TLR)
• Secondary Endpoints– Individual components of TLF: cardiac death, TV-related MI, ID-TLR– Patient-oriented composite outcome
: all-cause death, all-cause MI, all repeat revascularization– Definite or probable ST (according to ARC definition)
• Detection of Longitudinal Stent Deformation (LSD)
: by visual estimation of angiograph at index PCI
Statistical AssumptionStatistical Assumption
• Assumption : TLF
– 6.5% in PtCr-EES group
– 6.5% in CoCr-ZES group
TLF = 4 ~ 8% (COMPARE-II, PLATINUM, SPIRIT-IV, RESOLUTE-AC)
• Non-inferiority Margin: Hazard Ratio 1.5 (1-sided)
– Type I error (1-sided α): 2.5%
– Sampling ratio = 2:1
– Attrition rate: 5%
– Primary Analysis: Intention-to-treat analysis
– Statistical power >80% (β<0.20)
N=3,750
Non-inferiority Design for Primary Endpoint
(TLF at 12 Months)
Non-inferiority Design for Primary Endpoint
(TLF at 12 Months)
Hyo-Soo Kim
Web-based online randomization system
Dream CIS Inc. (contract research organization)
Seung-Woo Park, Young-Jin Choi, Kwangil Kim
Yong-Seok Kim, Sang Min Park, Kyung-Il Park(blinded to treatment allocation)
Trial CoordinationTrial Coordination
Random SequenceGeneration
Data Safety Monitoring Board
Data Management
Clinical Event Adjudication Committee
Principal Investigator
Hyo-Soo Kim, In-Ho Chae, Kwang Soo Cha,Byoung Eun Park, Jay Young Rhew, Hui-Kyung Jeon
Executive Committee
Participating CentersParticipating Centers40 major hospitals in Republic of Korea
Site PI
Seoul National University Hospital Kim, Hyo-Soo
Seoul National University Bundang Hospital Chae, In-Ho
Pusan National University Hospital Cha, Kwang Soo
Dankook University Hospital Park, Byoung Eun
Presbyterian Medical Center Rhew, Jay Young
Uijeongbu St. Mary’s Hospital Jeon, Hui-Kyung
Ulsan University Hospital Shin, Eun Seok
Samsung Changwon Hospital Oh, Ju Hyeon
Chonnam National University Hospital Jeong, Myung-Ho
Chungbuk National University Hospital Hwang, Kyung-Kuk
Wonju Christian Hospital Yoon, Jung-Han
Inje University Ilsan Paik Hospital Lee, Sung Yun
Boramae Medical Center Kim, Sanghyun
Dong-A Medical Center Park, Tae-Ho
Gangnam Severance Hospital Kwon, Hyuck-Moon
St. Vincent’s Hospital Moon, Keon Woong
Daegu Catholic University Medical Center Ryu, Jae-Kean
Keimyung University Dongsan Medical Center Hur, Seung-Ho
Daegu Fatima Hospital Lee, Bong-Ryul
Gyeongsang National University Hospital Park, Yong-Whi
Site PI
Konyang University Hospital Bae, Jang-Ho
Hallym University Kangdong Sacred Heart Hospital Han, Kyoo-Rok
Ewha Womans University Mokdong Hospital Park, Si-Hoon
Korea University Guro Hospital Rha, Seung-Woon
Hallym University Sacred Heart Hospital Park, Woo-Jung
Wongwang University Hospital Oh, Seok-Kyu
Korea University Anam Hospital Lim, Do-Sun
Kwangju Christian Hospital Lee, Seung-Wook
Hallym University Chuncheon Sacred Heart Hospital Hyun Hee Choi
Kyung Hee University Hospital at Gangdong Kim, Chong-Jin
Seoul Medical Center Kim, Seok-Yeon
Gachon University Gil Hospital Ahn, Taehoon
Samsung Medical Center Gwon, Hyeon-Cheol
Hallym University Kangnam Sacred Heart Hospital Lee, Namho
National Health Insurance Medical Center Jeon, Dong-Woon
Soonchunhyang University Hospital Hyun, Min-Soo
Daejun Eulji University Hospital Yu Jeong Choi
Hanyang University Guri Hospital Seong Il Choe
Kangwon National University Hospital Ryu, Dong Ryeol
Kosin University Gospel Hospital Cha, Tae-Joon
Trial FlowTrial Flow
Allocated to PtCr-EESAllocated to PtCr-EESN=2,503N=2,503
Allocated to CoCr-ZESN=1,252
Completed 1-Year F/UCompleted 1-Year F/UN=2,470 (98.7%)N=2,470 (98.7%)
Completed 1-Year F/UN=1,236 (98.7%)
9 withdrew 7 voluntarily 2 by physician’s decision7 were lost to follow up
17 withdrew 14 voluntarily 3 by physician’s
decision16 were lost to follow up
3,755 PatientsEnrolled and Randomized
Baseline CharacteristicsBaseline Characteristics
CharacteristicCharacteristic PtCr-EESPtCr-EES(N=2,503)(N=2,503)
CoCr-ZESCoCr-ZES(N=1,252)(N=1,252)
Age 63.1±10.8 63.5±10.7
Men 1,746 (69.8) 820 (65.6)
Body mass index 24.6±3.2 24.7±3.2
Hypertension 1,706 (68.2) 852 (68.1)
Diabetes 795 (31.8) 401 (32.0)
Dyslipidemia 1,601 (64.0) 822 (65.7)
Current smoker 823 (32.9) 369 (29.5)
Chronic renal failure 59 (2.4) 36 (2.9)
Peripheral artery disease 41 (1.6) 27 (2.2)
Cerebrovascular disease 172 (6.9) 79 (6.3)
Previous PCI 247 (9.9) 120 (9.6)
Previous bypass surgery 16 (0.6) 10 (0.8)
Pervious MI 116 (4.6) 49 (3.9)
Previous CHF 41 (1.6) 13 (1.0)
Clinical diagnosis
Slient ischemia 119 (4.8) 63 (5.0)
Stable angina 746 (29.8) 367 (29.3)
Unstable angina 903 (36.1) 476 (38.0)
NSTEMI 452 (18.1) 209 (16.7)
STEMI 283 (11.3) 137 (10.9)
ACS 65.5%
Baseline CharacteristicsBaseline Characteristics
CharacteristicCharacteristic PtCr-EESPtCr-EES(N=2,503)(N=2,503)
CoCr-ZESCoCr-ZES(N=1,252)(N=1,252)
Laboratory findings
Left ventricular ejection fraction (%) 59.9±10.4 60.4±10.2
Hemoglobin (g/dL) 13.7±1.7 13.7±1.7
Platelet count (x103/mm) 227±61 227±64
Serum creatinine (mg/dL) 1.00±0.73 1.00±0.87
Total cholesterol (mg/dL) 177±43 178±45
Triglyceride (mg/dL) 138±87 144±107
HDL-cholesterol (mg/dL) 44±12 44±11
LDL-cholesterol (mg/dL) 110±41 109±38
Medications at discharge
Aspirin 2,485 (99.3) 1,247 (99.6)
Clopidogrel 2,483 (99.2) 1,246 (99.5)
β-blocker 1,710 (68.3) 845 (67.5)
Calcium channel blocker 526 (21.0) 236 (18.8)
ACE inhibitor or ARB 1,636 (65.4) 829 (66.2)
Statin 2,122 (84.8) 1,076 (85.9)
Lesion & Procedural CharacteristicsLesion & Procedural Characteristics
CharacteristicCharacteristic PtCr-EESPtCr-EES(N=2,503)(N=2,503)
CoCr-ZESCoCr-ZES(N=1,252)(N=1,252)
Patient-Level Angiographic disease extent: 1VD 1,150 (45.9) 580 (46.3) 2VD 807 (32.2) 400 (31.9) 3VD 546 (21.8) 272 (21.7) Target lesions to be treated: One 1,766 (70.6) 909 (72.6) Two 570 (22.8) 286 (22.8) ≥ Three 167 (6.7) 57 (4.6) Use of IVUS or OCT 1,037 (41.4) 494 (39.5) Use of glycoprotein IIb/IIIa inhibitors 55 (2.2) 37 (3.0)
Lesion-Level (N=3,426) (N=1,661) Target vessel location: LMCA 74 (2.2) 37 (2.2) LAD 1,623 (47.4) 852 (51.3) LCX 751 (21.9) 324 (19.5) RCA 978 (28.5) 448 (27.0) ACC/AHA classification B2/C type 1,662 (49.7) 842 (51.7) Total occlusion 422 (12.3) 193 (11.6) Thrombus-containing 45 (1.3) 25 (1.5) Bifurcation 874 (25.6) 420 (25.3)
QCA AnalysisQCA Analysis
CharacteristicCharacteristic PtCr-EESPtCr-EES(N=2,938)(N=2,938)
CoCr-ZESCoCr-ZES(N=1,425)(N=1,425)
P ValueP Value
Before index procedure Lesion length 19.3±11.8 19.8±12.4 0.229 Reference vessel diameter 3.00±0.50 3.00±0.50 0.457 Minimum lumen diameter 0.81±0.50 0.81±0.50 0.657 Percent stenosis – % 73.1±15.4 72.8±15.5 0.470 SYNTAX score, before procedure 12.1±8.0 12.4±8.1 0.299
After index procedure SYNTAX score, after procedure 4.0±5.4 4.0±5.4 0.852 Number of stents Per lesion 1.19±0.45 1.17±0.43 0.301
Per patient 1.62±0.92 1.56±0.85 0.061 Total stent length – mm Per lesion 27.7±13.3 28.7±14.6 0.022
Per patient 37.6±24.2 37.9±25.0 0.764 Minimum lumen diameter In-stent 2.61±0.43 2.62±0.45 0.465
In-segment 2.23±0.53 2.21±0.52 0.397 Diameter stenosis – % In-stent 11.0±7.4 11.2±8.1 0.538
In-segment 21.5±11.2 22.2±11.4 0.051 Acute gain – mm In-stent 1.80±0.53 1.81±0.55 0.798
In-segment 1.42±0.58 1.40±0.59 0.275
0 2 4 6 8 10 12
5.0
4.0
3.0
2.0
1.0
0.0
PtCr-EES 2,503 2,446 2,426 2,408 2,401 2,376 1,887
CoCr-ZES 1,252 1,222 1,213 1,209 1,205 1,198 952
Months After Enrollment
Tar
get
Les
ion
Fai
lure
(%
)
PtCr-EES: PtCr-EES: 2.9%2.9%
CoCr-ZES: CoCr-ZES: 2.9%2.9%
HR: 1.00 (0.67-1.50)Non-Inferiority P-value (1-sided)=0.02
Superiority P-value=0.98
Patient Number At Risk
Target Lesion FailureTarget Lesion FailureComposite of C-death, TV-related MI, ischemia-driven TLR
Hypothesis TestingHypothesis Testing
0.5 1.0 1.5 2.0
Hazard Ratio of PtCr-EES vs. CoCr-ZES
P-value Function Curve
0.0
0.2
0.4
0.6
0.8
1.0
p-va
lue
PredefinedNon-Inferiority
Margin
α=0.0247
1-sided80% CI
90% CI
95% CI
0.5 1.0 1.5
Hazard Ratio of PtCr-EES vs. CoCr-ZES
Predefined margin: 1.5
Non-inferiority P=0.0247
1.4986 : Upper 97.5% CI
97.5% CI
Clinical OutcomesClinical Outcomes
End pointEnd pointPtCr-EESPtCr-EES CoCr-ZESCoCr-ZES
HR (95% CI)HR (95% CI) P-P-valuevalue(N=2,503) (N=1,252)
Target Lesion Failure 72 (2.88%) 36 (2.88%) 1.00 (0.67-1.50) 0.983 All-Cause Death 56 (2.24%) 20 (1.60%) 1.40 (0.84-2.34) 0.194 Cardiac Death 34 (1.36%) 17 (1.36%) 1.00 (0.56-1.79) 0.997 All-Cause MI 28 (1.12%) 17 (1.36%) 0.83 (0.45-1.51) 0.533 Target Vessel-Related MI 24 (0.96%) 13 (1.04%) 0.93 (0.47-1.82) 0.822
Repeat Revascularization 74 (2.96%) 33 (2.64%) 1.13 (0.75-1.70) 0.557
Target Lesion Revascularization 31 (1.24%) 15 (1.20%) 1.04 (0.56-1.93) 0.900
Target Vessel Revascularization 42 (1.68%) 23 (1.84%) 0.92 (0.55-1.53) 0.746
Cerebrovascular Accident 17 (0.68%) 8 (0.64%) 1.07 (0.46-2.47) 0.879
Ischemic 15 (0.60%) 6 (0.48%) 1.26 (0.49-3.24) 0.636
Hemorrhagic 2 (0.08%) 2 (0.16%) 0.50 (0.07-3.55) 0.489
All PLATO Bleeding 45 (1.80%) 25 (2.00%) 0.90 (0.55-1.47) 0.674
Major Bleeding 27 (1.08%) 16 (1.28%) 0.84 (0.45-1.57) 0.591
Major, life-threatening 4 (0.16%) 4 (0.32%) 0.50 (0.13-2.00) 0.327
Major, other 23 (0.92%) 13 (1.04%) 0.89 (0.45-1.75) 0.725
Minor Bleeding 18 (0.72%) 9 (0.72%) 1.00 (0.45-2.23) 0.996
Target Vessel Failure 82 (3.28%) 42 (3.35%) 0.98 (0.68-1.42) 0.919
Patient-Oriented Clinical Outcome 135 (5.39%) 55 (4.39%) 1.24 (0.90-1.69) 0.187
PtCr-EESPtCr-EESN=2,503N=2,503
CoCr-ZESCoCr-ZESN=1,252N=1,252
Clinical Events at 12 MonthsClinical Events at 12 Months
Cardiac Death
p=0.997
1.4% 1.4%1.0% 1.0% 1.2% 1.2%
5.4%
4.4%
TV related-MI
p=0.822
Target LesionRevascularization
p=0.900
Patient-Oriented Composite
p=0.187
PtCr-EESPtCr-EESN=2,503N=2,503
CoCr-ZESCoCr-ZESN=1,252N=1,252
PtCr-EESPtCr-EESN=2,503N=2,503
CoCr-ZESCoCr-ZESN=1,252N=1,252
PtCr-EESPtCr-EESN=2,503N=2,503
CoCr-ZESCoCr-ZESN=1,252N=1,252
Stent ThrombosisStent Thrombosis
PtCr-EESPtCr-EES(N=2,503)
CoCr-ZES(N=1,252)
p-value
Definite or probable ST 9 (0.36%) 8 (0.67%) 0.229 Acute definite or probable ST 1 (0.04%) 1 (0.08%) 1.000 Subacute definite or probable ST 7 (0.28%) 6 (0.50%) 0.379 Early definite or probable ST 8 (0.32%) 7 (0.58%) 0.273 Late definite or probable ST 1 (0.04%) 1 (0.08%) 1.000 Definite ST 5 (0.20%) 3 (0.25%) 1.000 Acute definite ST 0 (0.00%) 1 (0.08%) 0.333 Subacute definite ST 5 (0.20%) 1 (0.08%) 0.671 Early definite ST 5 (0.20%) 2 (0.17%) 1.000 Late definite ST 0 (0.00%) 1 (0.08%) 0.333 Probable ST 4 (0.16%) 5 (0.42%) 0.171 Acute probable ST 1 (0.04%) 0 (0.00%) 1.000 Subacute probable ST 2 (0.08%) 5 (0.42%) 0.045 Early probable ST 3 (0.12%) 5 (0.42%) 0.127 Late probable ST 1 (0.04%) 0 (0.00%) 1.000 Possible ST 15 (0.60%) 6 (0.50%) 0.642 Acute possible ST 0 (0.00%) 0 (0.00%) - Subacute possible ST 0 (0.00%) 0 (0.00%) - Early possible ST 0 (0.00%) 0 (0.00%) - Late possible ST 15 (0.60%) 6 (0.50%) 0.642
Late possible ST : Any unexplained death beyond 30 days
Stent ThrombosisStent Thrombosis
Definite ST
p=1.000
0.20% 0.25%0.16%
0.42%
Probable ST
p=0.171
PtCr-EESPtCr-EESN=2,503N=2,503
CoCr-ZESCoCr-ZESN=1,252N=1,252
PtCr-EESPtCr-EESN=2,503N=2,503
CoCr-ZESCoCr-ZESN=1,252N=1,252
0.60%0.50%
Possible ST
p=0.642
PtCr-EESPtCr-EESN=2,503N=2,503
CoCr-ZESCoCr-ZESN=1,252N=1,252
0.36%
0.67%
Definite or Probable ST
p=0.229
PtCr-EESPtCr-EESN=2,503N=2,503
CoCr-ZESCoCr-ZESN=1,252N=1,252
SubgroupTarget Lesion Failure
Hazard Ratio (95% CI)P Value forInteractionPtCr-EES CoCr-ZES
Age 0.395 ≥65 years 47/1182 (4.0) 27/617 (4.4) 0.91 (0.57 -1.46) <65 years 25/1321 (1.9) 9/635 (1.4) 1.35 (0.63 -2.90) Sex 0.371 Men 43/1746 (2.5) 23/820 (2.8) 0.88 (0.53 -1.46) Women 29/757 (3.8) 13/432 (3.0) 1.29 (0.67 -2.48) Acute Coronary Syndrome 0.779 Yes 50/1638 (3.1) 26/822 (3.2) 0.97 (0.60 -1.56) No 22/865 (2.5) 10/430 (2.3) 1.09 (0.52 -2.31) Diabetes Mellitus 0.912 Yes 29/795 (3.6) 15/401 (3.7) 0.97 (0.52 -1.81) No 43/1708 (2.5) 21/851 (2.5) 1.03 (0.61 -1.74) Number of Lesions to be Treated 0.114 One 53/1766 (3.0) 22/909 (2.4) 1.25 (0.76 -2.06) More than two 19/737 (2.6) 14/343 (4.1) 0.63 (0.32 -1.25) Lesion Length 0.346 ≤ 20 mm 34/1575 (2.2) 14/765 (1.8) 1.24 (0.61 -2.50) > 20 mm 27/623 (4.3) 18/340 (5.3) 0.82 (0.47 -1.41) Reference Vessel Diameter 0.030 ≤ 2.75 mm 31/983 (3.2) 23/464 (5.0) 0.63 (0.37 -1.08) > 2.75 mm 39/1486 (2.6) 13/777 (1.7) 1.58 (0.85 -2.97) Multivessel Stenting 0.471 Yes 51/1858 (2.7) 23/927 (2.5) 0.82 (0.41 -1.63) No 21/645 (3.3) 13/325 (4.0) 1.11 (0.68 -1.82) Allocated Antiplatelet Arm 0.885 Triple Antiplatelet 37/1253 (3.0) 19/626 (3.0) 0.97 (0.56 -1.69) Double Dose Dual Antiplatelet 35/1250 (2.8) 17/626 (2.7) 1.04 (0.58 -1.85)
Overall 72/2503 (2.9) 36/1252 (2.9) 1.00 (0.67 -1.50)
Subgroup AnalysisSubgroup Analysis
0.25 0.5 1 2 4
Favors PtCr-EES Favors CoCr-ZES
5,087 lesions (3,755 Patients)
Systematic review of CAG Systematic review of CAG to assess Longitudinal Stent Deformationto assess Longitudinal Stent Deformation
PtCr-EES: 3,426PtCr-EES: 3,426PtCr-EES: 3,426PtCr-EES: 3,426 CoCr-ZES: 1,661CoCr-ZES: 1,661
5,010 lesions (3,711 Patients)
PtCr-EES: PtCr-EES: 3,3673,367PtCr-EES: PtCr-EES: 3,3673,367 CoCr-ZES: 1,643CoCr-ZES: 1,643
3,772 lesions (3,016 Patients)
PtCr-EES: PtCr-EES: 2,5162,516PtCr-EES: PtCr-EES: 2,5162,516 CoCr-ZES: 1,256CoCr-ZES: 1,256
2,503 lesions (2,118 Patients)
PtCr-EES: PtCr-EES: 1,6851,685PtCr-EES: PtCr-EES: 1,6851,685 CoCr-ZES: 818CoCr-ZES: 818
Nominal SLRmeasurable(74.3% of lesions)
AcceptableAngiographic Images(98.5% of lesions)
Post-Deployment SLRmeasurable(49.2% of lesions)
Enrolled lesions
1. Bifurcation stenting2. Overlapping stenting3. Different Projection angle
No procedure after deployment
•adjunctive ballooning•IVUS or OCT
““LSD”LSD”
3,755 Patients(5,087 lesions)
Acceptableangiographicimages
PtCr-EESPtCr-EES2,471 Patients (3,367 2,471 Patients (3,367
lesions)lesions)
PtCr-EESPtCr-EES2,471 Patients (3,367 2,471 Patients (3,367
lesions)lesions)
CoCr-ZES1,240 Patients (1,643
lesions)
CoCr-ZES1,240 Patients (1,643
lesions)
Longitudinal Stent DeformationLongitudinal Stent Deformation
PtCr-EESPtCr-EES2,503 Patients (3,426 2,503 Patients (3,426
lesions)lesions)
PtCr-EESPtCr-EES2,503 Patients (3,426 2,503 Patients (3,426
lesions)lesions)
CoCr-ZES1,252 Patients (1,661
lesions)
CoCr-ZES1,252 Patients (1,661
lesions)
7 (0.21%)
0 (0.00%)
P=0.104
PtCr-EESPtCr-EES CoCr-ZESCoCr-ZES
Incidence: 2.1 (95% CI: 0.8-4.3) per 1,000 lesions treated with PtCr-EES
Longitudinal Stent DeformationLongitudinal Stent Deformation• Features of LSD by visual estimation
Details of 7 Patients with LSDDetails of 7 Patients with LSD
Age/Sex
Lesion Loci
Stent Size (mm)
PrecipitatingFactor
Bifurcation
Ostial Lesion
Segment of Stent Involved
Additional Stenting Required
Future Clinical Events
61/M LMCAP-E
3.0x24Deep engagement of guiding
catheter (GC)Yes Yes Proximal part No NoNo
59/M LMCAP-E
3.0x28
Deep engagement of GC d/t trapped retrograde guidewire
(CTO) No No Proximal part No NoNo
50/F Mid LADP-E
4.0x28Deep engagement of GC d/t
trapped IVUS catheterNo No Proximal part No NoNo
72/MProximal
RCAP-E
3.0x28Deep engagement of GC d/t
trapped stentNo No Proximal part No NoNo
39/MProximal
LADP-E
4.0x28Advancing Adjunctive
Balloon catheterYes No Proximal part No NoNo
81/F Mid LADP-E
3.0x20Advancing Adjunctive
Balloon catheterYes No Proximal part Yes NoNo
68/M Mid LADP-E
3.0x28Advancing Adjunctive
Balloon catheterNo No Proximal part No NoNo
Before Deployment: 24.27 mm
After Deployment: 23.14 mm
Final: 21.05 mm
Stent Length RatioStent Length Ratio : index of systemic assessment of stent shortening: index of systemic assessment of stent shortening
Promus-Element: Promus-Element: 3.0x283.0x28 mm mm
d/t shortening by projection angle
d/t shortening by expansion
d/t shortening by 1) LSD
2) projection angle difference
Nominal Stent Length RatioNominal Stent Length Ratio
0.6
0.8
1.0
1.2
1.4
0.92±0.07 vs. 0.93±0.07(P<0.001)
PtCr-EESPtCr-EES CoCr-ZESCoCr-ZESMaximum 1.18 1.3175% Quartile 0.97 0.9850% Median 0.93 0.9425% Quartile 0.88 0.89Minimum 0.55 0.65
PtCr-EESPtCr-EES(2,516 (2,516
lesions)lesions)
CoCr-ZESCoCr-ZES(1,256 lesions)(1,256 lesions)
Nominal Stent Length (mm)
0 20 40 600
10
20
30
40
50
Final Stent Length (mm)
PtCr-EES: PtCr-EES: 0.92±0.07 (R2=0.906)
CoCr-ZES: CoCr-ZES: 0.93±0.07 (R2=0.934)
(P<0.001)
Nominal Stent Length RatioNominal Stent Length Ratio
Min 1st Q Median 3rd Q Max
PtCr-EES 0.545 0.883 0.931 0.971 1.181
CoCr-ZES 0.645 0.889 0.939 0.981 1.313
Post-Deployment Stent Length RatioPost-Deployment Stent Length Ratio
0.8
1.0
1.2
PtCr-EESPtCr-EES(1,685 lesions)(1,685 lesions)
CoCr-EESCoCr-EES(818 lesions)(818 lesions)
1.00±0.04 vs. 1.00±0.04(P=0.352)
PtCr-EESPtCr-EES CoCr-ZESCoCr-ZES
Maximum 1.29 1.30
75% Quartile 1.01 1.01
50% Median 1.00 1.00
25% Quartile 0.98 0.98
Minimum 0.78 0.85
Post-Deployment Stent Length RatioPost-Deployment Stent Length Ratio
0 10 20 30 40 500
10
20
30
40
50
PtCr-EES: PtCr-EES: 1.00±0.04 (R2=0.974)
CoCr-ZES: CoCr-ZES: 1.00±0.04 (R2=0.984)
(P=0.352)
Min 1st Q Median 3rd Q Max
PtCr-EES 0.776 0.977 0.997 1.013 1.287
CoCr-ZES 0.846 0.980 1.000 1.013 1.295
Stent Length Immediately After Deployment (mm)
Final Stent Length (mm)
5,087 lesions (3,755 Patients)
Summary : Systematic review of CAG Summary : Systematic review of CAG to assess Longitudinal Stent Deformationto assess Longitudinal Stent Deformation
PtCr-EES: 3,426PtCr-EES: 3,426PtCr-EES: 3,426PtCr-EES: 3,426 CoCr-ZES: 1,661CoCr-ZES: 1,661
Nominal SLR(74.3% of lesions)
Acceptable Angiographic Images(98.5% of lesions)
Post-Deployment SLR(49.2% of lesions)
LSD rare only in Promus ElementLSD rare only in Promus Element
unreliableunreliable
more reliablemore reliableno difference between two stentsno difference between two stentsIn the general tendency In the general tendency of shortening of stent platformof shortening of stent platform
LimitationsLimitations
1. Lower event rates than expected
- Expected rate of primary endpoint in the comparator: 6.5%
- Actual event rate: 2.9%
2.2. Question of under-reportingQuestion of under-reporting
- Trials done in East Asian populations have reported lower event rates.
- This study was done with highest degree of scrutiny with periodic monitoring.- F/U loss rate: 1.3%
(lower than ENDEAVOR IV, SPIRIT IV, PLATINUM, HORIZONS-AMI)
3. Longer-term clinical follow-up required
- Clinical F/U will be continued up to 3 years
4.4. ““Eyeball” estimation Eyeball” estimation of longitudinal stent deformationof longitudinal stent deformation
- Better visibility of PtCr alloy may have led to more frequent detection of LSD
1) PtCr-EES was non-inferiornon-inferior to CoCr-ZES at 1 year regarding TLF.
Clinical outcomes were very similar very similar between the two stents.
2) Both stents demonstrated outstanding safety outstanding safety as well as efficacy.efficacy.
: ST <1%; TLF <3% in PCI population of “all-comers”
3)3) LSDLSD was very rare, observed only in a few cases of PtCr-EES, and
was not associated with future adverse clinical events. not associated with future adverse clinical events. There There
was was not a serious systematic shortening not a serious systematic shortening of either stent platform. of either stent platform.
Randomized Comparison of PtCr-EES vs CoCr-ZES Randomized Comparison of PtCr-EES vs CoCr-ZES
in All-Comers Receiving PCIin All-Comers Receiving PCI
: The HOST-ASSURE Randomized Trial: The HOST-ASSURE Randomized Trial
Hyo-Soo Kim, MD/PhD
Kyung-Woo Park, Si-Hyuck Kang, Kwang-Soo Cha,
Byoung-Eun Park, Jay-Young Rhew, Hui-Kyung Jeon, In-Ho Chae
On Behalf of The HOST-ASSURE Trial Investigators
Seoul National University Hospital, Seoul, Korea