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Hyo-Soo Kim, MD/PhD Kyung-Woo Park, Si-Hyuck Kang, Kwang-Soo Cha,

Randomized Comparison of PtCr -EES v s CoCr-ZES in All-Comers Receiving PCI 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

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Hyo-Soo Kim, MD/PhD Kyung-Woo Park, Si-Hyuck Kang, Kwang-Soo Cha,

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  1. Randomized Comparison of PtCr-EES vsCoCr-ZES in All-Comers Receiving PCIThe 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

  2. Disclosures Kim HS reports receiving honorarium for lectures and research grants from Boston Scientific and Medtronic.

  3. Background • 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.

  4. Objectives PtCr-EES (Promus-Element) CoCr-ZES (Resolute) • [Hypothesis] • PtCr-EESis Non-Inferior to CoCr-ZESRegarding Target Lesion Failure at 12 month vs.

  5. Longitudinal Stent Deformation (LSD) : a trade-off of thin strut How often does it happen? Under what conditions does it occur? How severe can it be?

  6. Study Design Prospective, single-blinded, randomized multi-center trial 3,750 All Comers Receiving PCI 40 Centers in Korea Coronary Angiography PtCr-EES arm (N=2,500) CoCr-ZES arm (N=1,250) 2:1 Randomization Percutaneous Coronary Intervention Target Lesion Failure at 12 Months Post-PCI (Intention-To-Treat Analysis)

  7. Enrollment 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% • 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 • 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

  8. Study Endpoints • Primary Endpoint: 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

  9. Statistical Assumption Non-inferiority Design for Primary Endpoint (TLF at 12 Months) • 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

  10. Trial Coordination Principal Investigator Hyo-Soo Kim Executive Committee Hyo-Soo Kim, In-Ho Chae, KwangSoo Cha, ByoungEun Park, Jay Young Rhew, Hui-Kyung Jeon Data Management Dream CIS Inc. (contract research organization) Random SequenceGeneration Web-based online randomization system Data Safety Monitoring Board Seung-Woo Park, Young-Jin Choi, Kwangil Kim Clinical Event Adjudication Committee Yong-Seok Kim, Sang Min Park,Kyung-Il Park(blinded to treatment allocation)

  11. Participating Centers 40 major hospitals in Republic of Korea

  12. Trial Flow 3,755 PatientsEnrolled and Randomized Allocated to PtCr-EES N=2,503 Allocated to CoCr-ZES N=1,252 17 withdrew 14 voluntarily 3 by physician’s decision 16 were lost to follow up 9 withdrew 7 voluntarily 2 by physician’s decision 7 were lost to follow up Completed 1-Year F/U N=2,470 (98.7%) Completed 1-Year F/U N=1,236 (98.7%)

  13. Baseline Characteristics ACS 65.5%

  14. Baseline Characteristics

  15. Lesion & Procedural Characteristics

  16. QCA Analysis

  17. Target Lesion Failure Composite of C-death, TV-related MI, ischemia-driven TLR HR: 1.00 (0.67-1.50) Non-Inferiority P-value (1-sided)=0.02 Superiority P-value=0.98 PtCr-EES: 2.9% Target Lesion Failure (%) CoCr-ZES: 2.9% Months After Enrollment Patient Number At Risk

  18. Hypothesis Testing Non-inferiority P=0.0247 1.0 P-value Function Curve PredefinedNon-InferiorityMargin Predefined margin: 1.5 0.8 1.4986 : Upper 97.5% CI 0.6 1-sided 80% CI p-value 0.4 0.5 1.0 1.5 90% CI 0.2 95% CI α=0.0247 Hazard Ratio of PtCr-EES vs. CoCr-ZES 0.0 0.5 1.0 1.5 2.0 Hazard Ratio of PtCr-EES vs. CoCr-ZES 97.5% CI

  19. Clinical Outcomes

  20. Clinical Events at 12 Months Cardiac Death p=0.997 TV related-MI p=0.822 Target LesionRevascularization p=0.900 Patient-Oriented Composite p=0.187 5.4% 4.4% 1.4% 1.4% 1.2% 1.2% 1.0% 1.0% PtCr-EES N=2,503 CoCr-ZES N=1,252 PtCr-EES N=2,503 CoCr-ZES N=1,252 PtCr-EES N=2,503 CoCr-ZES N=1,252 PtCr-EES N=2,503 CoCr-ZES N=1,252

  21. Stent Thrombosis Late possible ST : Any unexplained death beyond 30 days

  22. Stent Thrombosis Definite ST p=1.000 Probable ST p=0.171 Possible ST p=0.642 Definite or Probable ST p=0.229 0.67% 0.60% 0.50% 0.42% 0.36% 0.25% 0.20% 0.16% PtCr-EES N=2,503 CoCr-ZES N=1,252 PtCr-EES N=2,503 CoCr-ZES N=1,252 PtCr-EES N=2,503 CoCr-ZES N=1,252 PtCr-EES N=2,503 CoCr-ZES N=1,252

  23. Subgroup Analysis 0.25 0.5 1 2 4 Favors PtCr-EES Favors CoCr-ZES

  24. Systematic review of CAG to assess Longitudinal Stent Deformation Enrolled lesions 5,087 lesions (3,755 Patients) PtCr-EES: 3,426 CoCr-ZES: 1,661 Acceptable Angiographic Images (98.5% oflesions) “LSD” 5,010 lesions (3,711 Patients) PtCr-EES: 3,367 CoCr-ZES: 1,643 Bifurcation stenting Overlapping stenting Different Projection angle Nominal SLR measurable (74.3% of lesions) 3,772 lesions (3,016 Patients) PtCr-EES: 2,516 CoCr-ZES: 1,256 • No procedure • after deployment • adjunctive ballooning • IVUS or OCT Post-Deployment SLR measurable (49.2% of lesions) 2,503 lesions (2,118 Patients) PtCr-EES: 1,685 CoCr-ZES: 818

  25. Longitudinal Stent Deformation 3,755 Patients(5,087 lesions) PtCr-EES 2,503 Patients (3,426 lesions) CoCr-ZES 1,252 Patients (1,661 lesions) Acceptable angiographic images PtCr-EES 2,471 Patients (3,367 lesions) CoCr-ZES 1,240 Patients (1,643 lesions) P=0.104 7 (0.21%) 0 (0.00%) PtCr-EES CoCr-ZES Incidence: 2.1 (95% CI: 0.8-4.3) per 1,000 lesions treated with PtCr-EES

  26. Longitudinal Stent Deformation • Features of LSD by visual estimation

  27. Details of 7 Patients with LSD

  28. Stent Length Ratio: index of systemic assessment of stent shortening Promus-Element: 3.0x28 mm Before Deployment: 24.27 mm After Deployment : 23.14 mm Final: 21.05 mm d/t shortening by projection angle d/t shortening by expansion d/t shortening by 1) LSD 2) projection angle difference

  29. Nominal Stent Length Ratio 0.92±0.07 vs. 0.93±0.07 (P<0.001) 1.4 1.2 1.0 0.8 0.6 PtCr-EES (2,516 lesions) CoCr-ZES (1,256 lesions)

  30. Nominal Stent Length Ratio Final Stent Length (mm) 50 40 30 PtCr-EES: 0.92±0.07 (R2=0.906) CoCr-ZES: 0.93±0.07 (R2=0.934) 20 10 (P<0.001) 0 0 20 40 60 Nominal Stent Length (mm)

  31. Post-Deployment Stent Length Ratio 1.00±0.04 vs. 1.00±0.04 (P=0.352) 1.2 1.0 0.8 PtCr-EES (1,685 lesions) CoCr-EES (818 lesions)

  32. Post-Deployment Stent Length Ratio Final Stent Length (mm) 50 40 PtCr-EES: 1.00±0.04 (R2=0.974) 30 CoCr-ZES: 1.00±0.04 (R2=0.984) 20 (P=0.352) 10 Stent Length Immediately After Deployment (mm) 0 0 10 20 30 40 50

  33. Summary : Systematic review of CAG to assess Longitudinal Stent Deformation 5,087 lesions (3,755 Patients) PtCr-EES: 3,426 CoCr-ZES: 1,661 Acceptable Angiographic Images (98.5% oflesions) LSD rare only in Promus Element Nominal SLR (74.3% of lesions) unreliable more reliable no difference between two stents In the general tendency of shortening of stent platform Post-Deployment SLR (49.2% of lesions)

  34. Limitations • Lower event rates than expected • Expected rate of primary endpoint in the comparator: 6.5% • Actual event rate: 2.9% • Question 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) • Longer-term clinical follow-up required • Clinical F/U will be continued up to 3 years • “Eyeball” estimation of longitudinal stent deformation • Better visibility of PtCr alloy may have led to more frequent detection of LSD

  35. Conclusions PtCr-EES was non-inferiorto CoCr-ZES at 1 year regarding TLF. Clinical outcomes were very similar between the two stents. Both stents demonstrated outstanding safety as well as efficacy.: ST <1%; TLF <3% in PCI population of “all-comers” LSD was very rare, observed only in a few cases of PtCr-EES, and was not associated with future adverse clinical events. There was not a serious systematic shortening of either stent platform.

  36. Randomized Comparison of PtCr-EES vs CoCr-ZES in All-Comers Receiving PCI: 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

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