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  1. Compare Trial2 year follow-up Peter Smits Maasstad Ziekenhuis Rotterdam The Netherlands

  2. Disclosures I have received a speaking fee from Abbott Vascular Research Foundation of the Cardiology Department has received unrestricted research grants from: Abbott Vascular Boston Scientific

  3. Compare Trial The COMPARE trial is a physician initiated single center prospective randomized trial comparing the Taxus Liberté™versus Xience V™ stent in an all-comer / real world situation

  4. Compare TrialPurpose of the study To study the outcome of 2e generationdrug eluting stents in a study design that reflects everyday clinical practice The study is patient oriented and uses only symptom driven clinical end-points

  5. Study Outline

  6. Study Outline Inclusion criteria • All patients eligible for PCI • Life expectancy of > 5 years Exclusion criteria • No dual antiplatelet therapy for 12 months • Cardiogenic shock at presentation • Expected planned major surgery within 1 month • Participation in another trial • No informed consent

  7. Patient Diagram and Follow-up Randomized (N=1800) XIENCE V(N=897) Taxus Liberté (N=903) Lost to f/u = 2 Lost to f/u = 1 No study stent = 6 No study stent = 4 1-Year Follow-up(N=1797; 99.8%) Taxus Liberté (N=902) XIENCE V(N=895) Lost to f/u = 2 Lost to f/u = 0 2-Year Follow-up(N=1795; 99.7%) XIENCE V(N=895) Taxus Liberté (N=900) Clinical events were adjudicated by an independent CEC Target vessel revascularizations were analysed by an independent QCA core lab.

  8. Endpoints Primary endpoint • All death, non fatal MI and Target Vessel Revascularization (TVR) at 12 months follow-up Secondary endpoints * • Cardiac death, non fatal MI, ischemic driven TLR rate annually during 5 years follow-up • All death, non fatal MI, TVR at 2 - 5 year follow-up • Incidence of definite, probable or possible stent thrombosis annually during 5 years follow-up * amended from 1,3 and 5 years to annual time points during 5 year follow up

  9. Baseline CharacteristicsClinical presentation 1800 pts.

  10. Clinical Presentation1800 pts. Taxus Xience ± 60% ACS p = ns

  11. Baseline Characteristics1800 patients / 2583 lesions

  12. AMI 25 % Left main 2 % Chronic renal failure 3 % Bifurcation 10 % Calcification 34 % Diabetes 18 % Direct stenting 34 % Saphenous graft 2 % Multistenting 62 % Multivessel 27 % Ostial 19 % NSTEMI 23 % Thrombus 24 % CTO 4 % COMPARE TRIAL “REAL WORLD”

  13. Summary 12 months endpoints Taxus Xience Cardiac death, MI and Ischemia driven TLR Primary endpoint : All death, MI and TVR P = 0.023 P = 0.005 Def. & Prob. stent thrombosis Myocardial infarction P = 0.007 P = 0.002 Kedhi et al. Lancet 2010; vol 375: 201-9

  14. Summary 12 months endpoints All death Cardiac death Taxus Xience P = 0.58 P = 0.81 TVR TLR P = 0.0001 P = 0.0002 Kedhi et al. Lancet 2010; vol 375: 201-9

  15. SPIRIT IV TRIAL COMPARE TRIAL 12 months result Everolimus better Paclitaxel better Everolimus better Paclitaxel better Overall Overall < 65 yr > 65 yr No diabetes Diabetes Male Female Female Male Diabetes No diabetes No ACS ACS Hypertension No hypertension Singlevessel Multivessel Hypercholesterol No hyperchol. BMI < 30 BMI > 30 Restenosis De Novo Stable angina No stable ang. No Acute MI Acute MI 1 lesions 2 or more lesions No proximal LAD Proximal LAD No complex Complex lesions Lesion < 20 mm Lesion ≥ 20 mm RVD < 2.75 RVD > 2.75 RVD ≥ 2.75 mm RVD < 2.75 mm Lesion < 13.3 Lesion > 13.3 0.1 Bail-out No Bail-out 1.0 0.1 10.0 1.0 0.1 10.0

  16. Dual anti platelet therapy ns ns ns P = 0.02 15.2 % * 11.4 %

  17. Primary Endpoint Result @ 2 yrMACE (all death, non-fatal MI and TVR) 13.7 % Taxus Xience Δ4.7 % 9.1 % Δ2.9 % 9.0 % 6.2 % P = 0.0016 (log-rank test) RR = 0.66 (0.50-0.86) # Patients at Risk Taxus 903 864 852 840 833 822 818 808 800 798 785 781 777 Xience 897 871 866 859 852 844 840 836 832 830 822 818 815

  18. Secondary Endpoint Result @ 2 yr MACE (cardiac death, non-fatal MI and TLR) Taxus Xience 11.4 % 8.2 % Δ4.0 % Δ3.3 % 7.4 % 4.9 % P = 0.0038 (log-rank test) RR = 0.65 (0.48-0.88) # Patients At Risk: Taxus 903 865 854 844 837 826 822 812 806 804 795 792 788 Xience 897 873 870 863 856 848 845 841 837 835 827 823 820

  19. First Stent Thrombosis @ 2 yr(Definite / Probable according to ARC) Taxus Xience 3.9 % Δ3.0 % 2.6 % P < 0.0001 (log-rank test) RR = 0.23 (0.11-0.49) Δ1.9 % 0.9 % 0.7 %

  20. Early, Late and Very Late stent Thrombosis(Definite / Probable according to ARC) Early ST 92 % pts on DAPT Late ST 70 % pts on DAPT Very Late ST 13 % pts on DAPT p = 0.002 RR 0.13 (0.04-0.58) p = 0.13 RR 0.38 (0.10-1.42) p = 0.013 RR 0.23 (0.07-0.81) Taxus Xience 1.7 % 1.5 % 0.9 % 0.2 % 0.3 % 0.3 % 0 15 30 30 360 420 480 540 600 660 720 60 120 180 240 300 360 Days

  21. First Definite Stent Thrombosis @ 2 yr(Definite according to ARC) Taxus Xience P < 0.0001 (log-rank test) RR = 0.21 (0.08-0.55) 2.7 % Annual increase 0.7% 2.0 % Δ2.1 % Δ1.7 % Annual increase 0.2% 0.6 % 0.3 %

  22. Endpoint Analysis @ 2 yrFirstNon Fatal MI Taxus Xience P = 0.0009 (log-rank test) RR = 0.52 (0.35-0.77) 7.6 % 5.4 % Δ3.7 % Δ2.6 % 3.9 % 2.8 %

  23. Endpoint Analysis @ 2 yrAll Death & Cardiac Death Taxus Xience P = 0.67 All Death Cardiac Death P = 0.49

  24. Endpoint Analysis @ 2yrIschemic driven TVR & TLR Taxus Xience P < 0.0001 RR = 0.40 (0.25–0.61) 7.7 % TVR 3.1 % Taxus Xience P = 0.0005 RR = 0.44 (0.27-0.71) TLR 5.9 % 2.6 %

  25. Subgroup analysis @ 2 yr Everolimus better Paclitaxel better RR ( 95% CI ) p value for interaction 0.1 10.0 1.0

  26. Conclusions • In this all-comertrial, reflecting a real world patient population, the major secondary endpoints at 2 years showed : • superiority of Xience V versus Taxus Liberté (p = 0.0016) • MI, TVR, TLR and Stent thrombosis consistently resulted in significant better outcomes for Xience V compared to Taxus Liberté • Between 1 and 2 years, when the vast majority of patients were no longer taking DAPT, a significant 77% reduction in very late definite or probable stent thrombosis in favour of Xience V was observed • While there was a significant reduction in primary and secondary endpoints in the general patient population with Xience V, no such difference was observed in diabetic patients at 1 and 2 year FU

  27. Investigators Elvin Kedhi Eugene McFadden Carlos van Mieghem Kaiyum Sheikjoesoef Peter Smits (PI) Jochem Wassing CEC & Core Lab & Statistics Cardialysis, Rotterdam DSMB Eric Boersma (chairman) Patrick Serruys Benno Rensing CEC Martijn Akkerhuis Jean-Paul Herrman Peter Radke Evelyne Regar Jeroen Vos Pascal Vranckx (chairman) COMPARE TRIAL