1. Compare Trial 2 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 Trial Purpose of the study To study the outcome of 2 e generation drug 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 Eligible Patients for PCI Guide-wire passage ± Predilatation Operator blinded 1:1 Randomisation Taxus LiberteXience V

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. 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

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

9. Baseline Characteristics Clinical presentation 1800 pts. Taxus 903 pts Xience 897 pts p Male72 %69 %0.11 Previous AMI17.6 %15.2 %0.37 Previous PCI13.6 %13.0%0.57 Previous CABG5.9 %6.7 %0.47 Previous CVA6.4 %4.2 %0.07 Peripheral artery disease3.5 %5.7 %0.07 Diabetes19 %17.1 %0.33 Smoking (active)29 %32.9 %0.23 Hypercholesterolemia49.9 %53.2 %0.24 Hypertension49.5 %46.5%0.29 Family History44.6 %44.5 %0.61

10. Clinical Presentation 1800 pts. TaxusXience p = ns ± 60% ACS

11. Baseline Characteristics 1800 patients / 2583 lesions TaxusXiencep Lesions12941286ns LM1.6 % 0.46 LAD37.4 %39.9 %0.46 RCX25.7 %23.2 %0.46 RCA33.3 %32.9 %0.46 Grafts1.9 %2.1 %0.55 Lesion per patient1.461.450.92 Stent length per lesion34.0 0.97 Stent per lesion1.571.670.07 GP 2b3a blockers32 % 0.64 B2 / C lesions73 %74%0.20

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

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

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

15. No diabetes Diabetes Female Male No ACS ACS Single vessel Multivessel Overall Everolimus better Paclitaxel better Restenosis De Novo No Acute MI Acute MI No proximal LAD Proximal LAD Lesion < 20 mm Lesion ≥ 20 mm RVD ≥ 2.75 mm RVD < 2.75 mm 0.1 1.0 10.00.1 COMPARE TRIAL Everolimus better Paclitaxel better SPIRIT IV TRIAL Overall Diabetes No diabetes < 65 yr > 65 yr Male Female 1.0 10.00.1 Hypertension No hypertension Hypercholesterol No hyperchol. BMI < 30 BMI > 30 Stable angina No stable ang. 1 lesions 2 or more lesions No complex Complex lesions RVD < 2.75 RVD > 2.75 Lesion < 13.3 Lesion > 13.3 Bail-out No Bail-out 12 months result

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

17. Primary Endpoint Result @ 2 yr MACE (all death, non-fatal MI and TVR) # 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 Taxus Xience P = 0.0016 (log-rank test) RR = 0.66 (0.50-0.86) 13.7 % 9.0 % Δ 4.7 % Δ 2.9 % 9.1 % 6.2 %

18. Secondary Endpoint Result @ 2 yr MACE (cardiac death, non-fatal MI and TLR) # 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 P = 0.0038 (log-rank test) RR = 0.65 (0.48-0.88) 11.4 % 7.4 % Taxus Xience Δ 3.3 % Δ 4.0 % 8.2 % 4.9 %

19. First Stent Thrombosis @ 2 yr (Definite / Probable according to ARC) 3.9 % 0.9 % Taxus Xience P < 0.0001 (log-rank test) RR = 0.23 (0.11-0.49) 0.7 % 2.6 % Δ 1.9 % Δ 3.0 %

20. Early ST 92 % pts on DAPT Early, Late and Very Late stent Thrombosis (Definite / Probable according to ARC) 01530 Days p = 0.002 RR 0.13 (0.04-0.58) 0.2 % 1.7 % p = 0.13 RR 0.38 (0.10-1.42) Taxus Xience 0.9 % 60120 180240300360 0.3 % 36042048054060066072030 1.5 % 0.3 % p = 0.013 RR 0.23 (0.07-0.81) Late ST 70 % pts on DAPT Very Late ST 13 % pts on DAPT

21. First Definite Stent Thrombosis @ 2 yr (Definite according to ARC) 2.7 % 0.6 % Taxus Xience P < 0.0001 (log-rank test) RR = 0.21 (0.08-0.55) 0.3 % 2.0 % Δ 1.7 % Δ 2.1 % Annual increase 0.7% Annual increase 0.2%

22. Endpoint Analysis @ 2 yr First Non Fatal MI Taxus Xience 7.6 % 3.9 % P = 0.0009 (log-rank test) RR = 0.52 (0.35-0.77) 5.4 % 2.8 % Δ 2.6 % Δ 3.7 %

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

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

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

26. Conclusions In this all-comer trial, 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