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Hyo-Soo Kim MD, PhD on behalf of the investigators Seoul National University Hospital, Seoul, Korea

E fficacy of X ience /Promus versus C ypher to r E duce L ate L oss in st ENT. Hyo-Soo Kim MD, PhD on behalf of the investigators Seoul National University Hospital, Seoul, Korea. Disclosure Statement of Financial Interest.

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Hyo-Soo Kim MD, PhD on behalf of the investigators Seoul National University Hospital, Seoul, Korea

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  1. Efficacy of Xience/Promus versus Cypher to rEduceLate Loss in stENT Hyo-Soo Kim MD, PhD on behalf of the investigators Seoul National University Hospital, Seoul, Korea

  2. Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Company Affiliation/Financial Relationship • Abbott Vascular • Boston Scientific • Medtronic • Cordis • Astra Zeneca, • Daichi Sankyo, • Eli Lily, • Sanofi Aventis • Grant • Research Support • Consulting Fees • Honoraria

  3. Background Everolimus-Eluting Stent Sirolimus-Eluting Stent

  4. Objective To evaluate the safety and long-term efficacyof Xience/Promus compared with the Cypher select Hypothesis • EES is non-inferiorto SES in • inhibiting neointimal growthat 9 months angiography

  5. Patient Eligibility

  6. Trial Design Prospective, open label, two-arm, randomized multi-center trial 1372 Patients Matching Enrollment Criteria 19 centers in Korea Everolimus-Eluting StentN=1029 Sirolimus-Eluting StentN=343 Randomization 3:1 DAT 6 moN=515 DAT 12 moN=514 DAT 6 moN=171 DAT 12 moN=172 2x2 factorial design Percutaneous Coronary Intervention Secondary clinical endpoint evaluation Clinical 1mo 3mo 9mo 12mo 2yr 3yr 4yr 5yr Angiographic Primary endpoint: In-segment LL Am Heart J 2009 May;157:811-817.e1.

  7. Study Endpoints • Primary Endpoint: In-segment late luminal loss (LL) at 9 months(for comparison of stenting with EES vs. SES) • Secondary Endpoints: • All Death, Cardiac death • Myocardial infarction (Q-wave and non-Q wave) • Target vessel revascularization (TVR) (all and ID) • Target lesion revascularization (TLR) (all and ID) • Stent thrombosis, Bleeding, CVA • Acute success (device, lesion, and clinical) • In-stent LL, and Angiographic pattern of restenosis at 9-month • In-stent and in-segment % diameter stenosis (%DS) at 9 months • In-stent % volume obstruction (%VO) at 9 months • Incomplete stent apposition post index procedure • Persisting incomplete stent apposition, late-acquired incomplete stent apposition, aneurysm, thrombosis, and persisting dissection at 9 months

  8. Statistical Assumption Primary Endpoint In-segment late luminal loss (LL) at 9 months • LL of EES: 0.2±0.41 mm (assumed) • LL of SES: 0.2±0.48 mm (SIRIUS, E-SIRIUS, C-SIRIUS, SIRTAX, SPIRIT II, III) • Non-inferiority margin: 0.1 mm(type I error: 0.05; statistical power: 90%; attrition: 20%)

  9. Independence in Trial Coordination

  10. Participating Centers 19 Hospitals in Republic of Korea • Gangnam Severance Hospital • NHIC Ilsan Hospital • Inje University Sanggye Paik Hospital • Korea University Anan Hospital • Pusan National University Hospital • Boramae Medical Center • Kangnam Sacred Heart Hospital • Uijeongbu St. Mary’s Hospital • Keimyung University Dongsan Hospital • EwhaWomans University Mokdong Hospital • Seoul National University Hospital • Yonsei University Severance Hospital • Samsung Medical Center • Seoul National University Bundang Hospital • Gachon University Gil Medical Center • Yonsei University Wonju Christian Hospital • Hallym University Sacred Heart Hospital • Kandgong Sacred Heart Hospital • Chonam National University Hospital

  11. Study Flow: Angiographic F/U Enrolled and randomized (N=1443) EESN=1079 SESN=364 Randomized 3:1 Received SES (335 Pts, 414 Lesions) Received EES (1054 Pts, 1388 Lesions) Angiographic F/U (64.5%) 216 Pts, 267 Lesions Angiographic F/U (67.3%) 709 Pts, 949 Lesions

  12. Baseline Profiles

  13. Baseline Profiles

  14. Lesion and Procedural Profiles *comparisons were performed using the generalized estimating equations (GEE). **compared with the Chi-square t-test

  15. Lesion and Procedural Profiles *comparisons were performed using the generalized estimating equations (GEE). **compared with the Chi-square test, and †with the independent t-test

  16. QCA Data(1) :all lesions *comparisons were performed using the generalized estimating equations (GEE).

  17. QCA Data(1) :all lesions *comparisons were performed using the generalized estimating equations (GEE). **compared with the Fishcer’s exact test

  18. In-segment late LL 1˚ Endpoint EES(N=935) • 0.10±0.36 mm SES(N=266) • 0.05±0.34 mm Mean ΔLL: 0.051 mm Upper 1-sided 95% CI: 0.091 mm Non-inferiority p-value 0.023 Prespecified non-inferiority margin: 0.1 mm Non-inferior Upper 1-sided 95% CI

  19. Minimal Luminal Diameters In-Sement 1˚ Endpoint 9-month F/U After Procedure Before Procedure 100 EES EES EES SES SES SES 80 60 % of Lesions 40 20 0 0.0 1.0 2.0 3.0 4.0 Minimal Luminal Diameter (mm)

  20. In-stent late LL Post-hoc EES(N=935) • 0.19±0.33 mm SES(N=266) • 0.15±0.33 mm Mean ΔLL: 0.043 mm Upper 1-sided 95% CI: 0.082 mm Non-inferiority p-value 0.007 Prespecified non-inferiority margin: 0.1 mm Non-inferior Upper 1-sided 95% CI

  21. Minimal Luminal Diameters In-Stent Post-hoc 9-month F/U After Procedure Before Procedure 100 EES EES EES SES SES SES 80 60 % of Lesions 40 20 0 0.0 1.0 2.0 3.0 4.0 Minimal Luminal Diameter (mm)

  22. Hard Endpoints 2˚ Endpoint : Composite of cardiac death, or MI 4.0 Log-Rank p-value=0.561 3.0 Cumulative incidence rate (%) SES: 1.9% 2.0 EES: 1.5% 1.0 0.0 0 3 6 9 12 Months after initial procedure

  23. Soft Endpoints 2˚ Endpoint TLR 5.0 Log-Rank p-value=0.400 4.0 3.0 EES: 2.4% Cumulative incidence rate (%) 2.0 SES: 1.7% 1.0 0.0 0 3 6 9 12 Months after initial procedure

  24. Target Lesion Failure 2˚ Endpoint : Composite of cardiac death, MI, or ID-TLR 5.0 EES: 3.7% Log-Rank p-value=0.552 4.0 3.0 Cumulative incidence rate (%) SES: 3.0% 2.0 1.0 0.0 0 3 6 9 12 Months after initial procedure

  25. Target Lesion Failure 2˚ Endpoint : Composite of cardiac death, MI, or ID-TLR 0.25 0.5 1 2 4 8 Favors EES Favors SES

  26. Stent Thrombosis 2˚ Endpoint : Definite/Probable ST by ARC definition 1.0 SES: 0.8% Log-Rank p-value=0.281 0.8 0.6 Cumulative incidence rate (%) EES: 0.4% 0.4 0.2 0.0 0 3 6 9 12 Months after initial procedure

  27. 2˚ Endpoint Myocardial Infarction MI, total p=1.000 MI, peri-procedural p=0.741 MI, spontaneous p=0.379 EES N=1,057 SES N=359 EES N=1,057 SES N=359 EES N=1,057 SES N=359

  28. Summary : EXCELLENT-RCT • The efficacy of EES was non-inferior to SES in inhibiting lateloss at 9 months & clinicalevents at 12 months. • The incidence of ST was not different between EES and SES although numerically lower in EES. • Tendency of higher late-loss in EES than SES may lead to the intriguing reciprocaltrend between soft versus hard endpoints : higher incidence of TLR but lower incidence of death, MI, or ST.  should be confirmed in the larger study in the future • Long term follow up will tell us whether Xience/Promus will offer similar efficacy along with better long term safety compared with the best 1st generation DES, Cypher.

  29. Efficacy of Xience/Promus versus Cypher to rEduceLate Loss in stENT Hyo-Soo Kim MD, PhD on behalf of the investigators Seoul National University Hospital, Seoul, Korea

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