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ENDEAVOR III

Clinical/MACE. 30d. 6mo. 8mo. 9mo. 12mo. 2yr. 3yr. 4yr. 5yr. Angio/IVUS. QCA IVUS. ENDEAVOR III. Multicenter Randomized Trial. 3:1 Randomization Single Blind – Single Vessel – No Staging. Single De Novo Native Coronary Lesions Vessel Diameter: 2.5-3.5 mm

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ENDEAVOR III

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  1. Clinical/MACE 30d 6mo 8mo 9mo 12mo 2yr 3yr 4yr 5yr Angio/IVUS QCA IVUS ENDEAVOR III Multicenter Randomized Trial 3:1 Randomization Single Blind – Single Vessel – No Staging Single De Novo Native Coronary Lesions Vessel Diameter: 2.5-3.5 mm Lesion Length: 14-27 mm Stent Lengths: 18-33 mm (8/9) mm bailout Pre-dilatation required Endeavor Stent n = 327 Cypher Stent n = 109 N = 436 patients 30 U.S. sites Clinical Endpoints Primary Endpoint: In-segment late lumen loss by QCA at 8 months Secondary Endpoints: TLR, TVR, TVF at 9 months & ABR at 8 months Antiplatelet therapy for ³3 months 10 g Zotarolimus per mm stent length

  2. ENDEAVOR III Study Objectives (2003) • To determine whether results of the Endeavor DES in a United States PCI population were similar to those observed in Endeavor trials conducted internationally • To determine whether 8 month angiographic outcomes (in-segment late loss) with the Endeavor DES are non-inferior to the FDA-approved Cypher DES

  3. ENDEAVOR III Outstanding Questions (2010) • Does higher late loss with Endeavor ZES stent (compared with Cypher SES) translate into greater late-term TLR beyond the period of angiographic follow-up? • What are the late-term safety outcomes of Endeavor ZES and Cypher SES? • Are Endeavor ZES outcomes consistent with late-term follow up observed in the overall Endeavor Clinical Trial program?

  4. Endeavor n = 323 Cypher n = 113 Angio F/U (8 mo) 277/323 85.8% Angio F/U (8 mo) 94/113 83.2% Clinical F/U Clinical F/U (12 mo) 321/323 99.4% (24 mo) 317/323 98.1% (36 mo) 314/323 97.2% (48 mo) 310/323 96.0% (60 mo) 307/323 95.0% (12 mo) 112/113 99.1% (24 mo) 112/113 99.1% (36 mo) 110/113 97.3% (48 mo) 110/113 97.3% (60 mo) 108/113 95.6% ENDEAVOR III Patient Flowchart Patients Enrolled N = 436 Randomized

  5. ENDEAVOR III Selected Baseline Characteristics

  6. ENDEAVOR III Dual Antiplatelet Therapy (DAPT) Data presented as percentages.

  7. ENDEAVOR III Angiographic and IVUS Results at 8 Months 1º Non-inferiority Endpoint Not Met

  8. ENDEAVOR III Clinical Outcomes to 60 Months

  9. ENDEAVOR III TLR, Cardiac Death/MI and MACE at 9 and 60 Months TLR Cardiac Death/MI MACE Δ 6.5% vs. 15.1% Δ 1.9% vs. 3.0% Δ 0.7% vs. 3.0% 9 months 60 months

  10. Endeavor Cypher ENDEAVOR III Cardiac Death/MI to 60 Months 15% £ 1 year Endeavor Cardiac Death/MI = 0.62% > 1 year through 5 years Endeavor Cardiac Death/MI = 0.67% P = 0.003 10% Cumulative Incidence of Cardiac Death or MI 6.5% 5% 1.3% 0% 0 360 720 1080 1440 1800 Time after Initial Procedure (days)

  11. Endeavor £ 1 year Endeavor ARC ST = 0.32% > 1 year through 5 years Endeavor ARC ST = 0.34 % Cypher ENDEAVOR III ARC ST Def/Prob to 60 Months 5% P = 0.756 4% 3% Cumulative Incidence of Def/Prob Thrombosis 2% 1% 1.0% 0.7% 0% 0 360 720 1080 1440 1800 Time after Initial Procedure (days)

  12. Endeavor £ 1 year Endeavor TLR = 6.6% > 1 year through 5 years Endeavor TLR = 1.4% Cypher ENDEAVOR III TLR to 60 Months 35% P = 0.547 30% 25% 20% Cumulative Incidence from TLR 15% 10% 8.0% 6.5% 5% 0% 0 360 720 1080 1440 1800 Time after Initial Procedure (days)

  13. Endeavor £ 1 year Endeavor MACE = 7.8% • 1 year through 5 years Endeavor MACE = 5.8% Cypher ENDEAVOR III MACE to 60 Months 35% P = 0.054 30% 25% 21.8% 20% Cumulative Incidence from MACE 15% 13.6% 10% 5% 0% 360 720 1080 1440 1800 Time after Initial Procedure (days)

  14. ENDEAVOR III Conclusion at 5 Years • In a trial designed to evaluate a primary angiographic endpoint,late lumen loss is greater with Endeavor ZES compared with the Cypher SES • Despite initially higher angiographic late loss with ZES, • Rates of TLR beyond period of protocol-mandated angiographic surveillance remain stable • Absolute differences between DES in clinical restenosis temporally decrease over late term • Recognizing limitations in sample size, late term (5y) follow up of the Endeavor stent demonstrates • Durability in efficacy (TLR) • Very low rate of VLST (1 event) • Compared with Cypher SES, emerging differences in cardiac death/MI and MACE achieving statistical significance • Late term EIII outcomes with the Endeavor ZES parallel theconsistent safety and efficacy observed across the Endeavor Clinical Trials Program

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