1. Compare Trial2 year follow-up Peter Smits Maasstad Ziekenhuis Rotterdam The Netherlands
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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
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. 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 = 0 Lost to f/u = 2 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.
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 10.0 0.1 1.0 10.0 0.1
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 30 360 420 480 540 600 660 720 30 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 %
25. Subgroup analysis @ 2 yr Paclitaxel better Everolimus 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. DSMB Eric Boersma (chairman) Patrick Serruys Benno Rensing CEC Martijn Akkerhuis Jean-Paul Herrman Peter Radke Evelyne Regar Jeroen Vos Pascal Vranckx (chairman) Investigators Elvin Kedhi Eugene McFadden Carlos van Mieghem Kaiyum Sheikjoesoef Peter Smits (PI) Jochem Wassing CEC & Core Lab & Statistics Cardialysis, Rotterdam COMPARE TRIAL
Notas del editor
The primary endpoint is defined as the composite of: all death etc.The secondary endpoints: like the composite of cardiac death etc. and the primary endpoint and the stent thrombosis were originally defined at 1, 3 and 5 year follow-up, but these have been amended to an annual reporting during the 5 years follow up period.
![Disclosures I have received a speaking fee from Abbott Vascular Research Foundation of the Cardiology Department has received unrestricted research grants from: ,[object Object]](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)