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Compare Trial

Compare Trial. Peter Smits Maasstad Ziekenhuis Rotterdam The Netherlands. 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)

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Compare Trial

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  1. Compare Trial Peter Smits Maasstad Ziekenhuis Rotterdam The Netherlands

  2. 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

  3. Disclosures No personal disclosures Research Foundation of the Cardiology Department has received unrestricted research grants from: Abbott Vascular Boston Scientific

  4. 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

  5. AMI Left main Chronic renal failure Bifurcation Calcification Diabetes Diffuse disease Saphenous graft Multistenting Multivessel Ostial Unstable angina Thrombus Long lesions CTO Randomized Controlled TrialsPitfalls “REAL WORLD”

  6. Compare TrialPurpose of the study To study the outcome of 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

  7. Taxus Liberté Paclitaxel TransluteTM Liberté™ Xience V VisionTM Everolimus Fluoropolymer

  8. Strut and Polymer Thickness CYPHER® TAXUS® Liberté ENDEAVOR XIENCE V 3.0 mm diameter stents, 500x magnification Data on file at Abbott Vascular.

  9. Rapid Re-endothelialization14-Day Rabbit Iliac Study XIENCE V CYPHER® TAXUS® ENDEAVOR Joner M et al. JACC 2008:52:333-342

  10. Study Outline Clinical events were adjudicated by an independent CEC Target vessel revascularizations were analysed by an independent QCA core lab. All patients were monitored for 12 months; only 3 pts (0.16%) were lost for FU.

  11. 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

  12. 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 at 12 months follow-up. • all death, non fatal MI, TVR at 3 and 5 years follow-up • incidence of definite, probable or possible stent thrombosis at 12 months, 3 and 5 years

  13. Baseline CharacteristicsClinical presentation 1800 pts.

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

  15. Baseline Characteristics1800 patients / 2583 lesions

  16. Lesion Characteristics 1800 patients / 2583 lesions Taxus Xience 73 % B2 / C 74 % B2 / C p = 0.20

  17. 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”

  18. Primary Endpoint ResultMACE (all death, non-fatal MI and TVR) Taxus Xience P = 0.023 (log-rank test) RR = 0.69 (0.50-0.95) 9.1 % Δ2.9 % Δ1.1% 6.2 % # Patients at Risk Taxus 903 868 865 860 853 849 842 838 833 825 823 822 819 Xience 897 872 870 867 865 864 858 854 851 849 844 842 840

  19. Secondary Endpoint ResultMACE (cardiac death, non-fatal MI and TLR) Taxus Xience P = 0.005 (log-rank test) RR = 0.60 (0.42-0.86) 8.2 % Δ3.3 % Δ1.2 % 4.9 % # Patients At Risk: Taxus 903 869 866 861 854 849 844 841 835 828 826 825 822 Xience 897 873 872 869 869 867 862 857 855 853 848 847 845

  20. Secondary Endpoint ResultStent Thrombosis (Definite & probable according to ARC) Taxus Xience P = 0.002 (log-rank test) RR = 0.26 (0.11-0.64) 2.6 % 0.7 %

  21. Secondary Endpoint ResultEarly and Late Stent Thrombosis(definite & probable according ARC) Early ST Late ST Taxus Xience Taxus Xience P = 0.002 P = 0.39

  22. Endpoint AnalysisNon Fatal MI Taxus Xience P = 0.007 (log-rank test) RR = 0.52 (0.33-0.84) 5.4 % 2.8 %

  23. Endpoint AnalysisAll Death & Cardiac Death Taxus Xience P = 0.58 All Death Cardiac Death P = 0.81

  24. Endpoint AnalysisTVR & Ischemic driven TLR Taxus Xience 6.0 % TVR P = 0.0001 2.4 % 4.8 % TLR P = 0.0002 1.7 %

  25. Conclusions • In an all-comerpopulation, reflecting real world, implantation of the Everolimus eluting Xience V stent significantly reduced major adverse cardiac events compared to the Paclitaxel eluting Taxus Liberté stent • Superiority of the Everolimus eluting Xience V stent was reached mainly due to less early stent thrombosis and less target lesion revascularization

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