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Endeavor II Five-Year Follow-Up: Sustained Clinical Benefit & Safety Profile

This paper presents the Endeavor II trial's five-year follow-up results, showcasing sustained clinical benefits and an excellent safety profile. The study compared the Endeavor zotarolimus-eluting stent (ZES) with the Driver stent, highlighting long-term outcomes and the unique biocompatible nature of the ZES polymer. The trial involved 1,200 patients across 72 sites, with primary endpoints focusing on target vessel failure and secondary endpoints on major adverse cardiac events. The results indicate favorable outcomes and no new stent thrombosis events, emphasizing the durability and safety of the ZES over time.

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Endeavor II Five-Year Follow-Up: Sustained Clinical Benefit & Safety Profile

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  1. Ian T. Meredith, MBBS, PhDMonashHEART Monash Medical Centre Melbourne, Australia On Behalf of the Endeavor II Investigators ENDEAVOR II Five-Year Clinical Follow-up

  2. Potential Conflicts Of Interest Speaker’s name: Ian T. Meredith • I have the following potential conflicts of interest to report: • Research contracts • Consulting • Employment in industry • Stockholder of a healthcare company • Owner of a healthcare company • Other(s) • I do not have any potential conflict of interest 2

  3. Endeavor DES System Driver Cobalt Alloy Stent Stent Delivery System PC Technology Drug: Zotarolimus

  4. Post-elution ~1-µm coating of PC polymer Stent strut ENDEAVOR CYPHER TAXUSLiberté XIENCE V Polymer and Drug Matrix PC overspray (~0.1 µm thick) Drug layer 90% zotarolimus (10 µg/mm) 10% PC (~2–3 µm thick) Stent strut PC basecoat (~1 µm thick)

  5. Single De Novo Native Coronary Artery Lesions Reference Vessel Diameter 2.25 mm-3.5 mm Lesion Length: 14-27 mm Pre-dilatation required ENDEAVOR II Double-Blind, Randomized Clinical Trial vs Driver PI: Jean Fajadet, William Wijns et. al. N = 1,200 patients 72 sites Europe, Asia Pacific, Israel, New Zealand and Australia Endeavor Stent Active Arm n=600 Driver Stent Control Arm n=600 Clinical/MACE 30d 6mo 8mo 9mo 12mo 2yr 3yr 4yr 5yr Angiography/IVUS Angio = first 600 pts IVUS = first 300 pts (plus IVUS for overlapping stents) Primary Endpoint: TVF at 9 monthsSecondary Endpoints: MACE at 30 days and 9 months, BR at 8 months Drug Therapy: ASA and Clopidogrel >3 months Zotarolimus Dose: 10 g per mm stent length Fajadet et al. Circulation. 2006;114:98-806.

  6. ENDEAVOR Clinical Program ENDEAVOR I First in Human 5 Years n = 97/100 (97%) Double-blind Randomized Trial 5 Years n = 577/598 (97%) ENDEAVOR II Continued Access Registry 4 Years n = 287/296 (97%) ENDEAVOR II CA Confirmatory Trial vs. Cypher 4 Years n = 307/323 (95%) ENDEAVOR III Confirmatory Trial vs. Taxus 2 Years n = 742/773 (96%) ENDEAVOR IV ENDEAVOR PK Pharmacokinetic Trial 2 Years n = 42/43 (98%) E-Five Post Market Surveillance 2 Years n = 2054/2116 (97%)

  7. Patients Enrolled N = 1197 Driver n = 599 Endeavor n = 598 Angio F/U (8 mo) 265/302 87.7% Angio F/U (8 mo) 264/298 88.6% ENDEAVOR II Patient Flowchart Randomized Clinical Follow-up Clinical Follow-up (1yr) 590/598 98.7% (2yr) 588/598 98.3% (3yr) 585/598 97.8% (4yr) 583/598 97.5% (5yr)577/598 96.5% (1yr) 590/599 98.5% (2yr) 588/599 98.2% (3yr) 587/599 98.0% (4yr) 584/599 97.5% (5yr)582/599 97.2%

  8. P<0.001 ENDEAVOR II TVF and TLR at 9 Months Primary Endpoint Target Vessel Failure* TLR P<0.001 47% 61% Driver Endeavor Driver Endeavor *Target Vessel Failure is a composite of target vessel revascularization, MI, or cardiac death.

  9. Log rank P = <0.001 Endeavor Driver Δ 9.0% 30% 25% Δ 7.1% 24.3% 20% Cumulative Incidence TVF 15.3% 15% 10% 5% 0% 0 9m 1 2 3 4 5 Time after Initial Procedure (years) ENDEAVOR II Cumulative Incidence of TVF to 5 years

  10. 30% Log rank P = <0.001 Endeavor 25% Driver Δ 9.1% 20% Δ 7.2% 16.5% 15% Cumulative Incidence TLR 10% 7.4% 5% 0% 3 0 9m 1 2 4 5 Time after Initial Procedure (years) ENDEAVOR II Cumulative Incidence of TLR to 5 years

  11. ENDEAVOR II TLR at 5 years P<0.001 P<0.001 P<0.001 P<0.001 P<0.001 TLR (%)

  12. ENDEAVOR II Summary of Clinical Events at 5 years

  13. ENDEAVOR II Clinical Performance at 5 years P<0.001 P<0.001 P<0.001 (%) P<0.001 P=0.188

  14. ENDEAVOR II Summary of ARC Stent Thrombosis to 5 years

  15. Pivotal Trials TLR: DES Arms Rates of TLR Over Time ENDEAVOR II(n=577/598) SIRIUS(n=501/533) TAXUS IV(n=618/662) 9.4 9.1 7.9 7.8 7.5 7.2 7.2 6.8 6.5 6.9 5.9 6.3 TLR (%) TLR (%) TLR (%) 5.6 4.9 4.4 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 Years of Follow-up Years of Follow-up Years of Follow-up 5 Year Clinical Results of TAXUS IV, Stone, ACC 2007 5 year Outcomes in the Sirius Trial, Weisz et al. JACC Vol. 53, No. 17, 2009 Results come from separate clinical trials. Data may differ in a head-to-head comparison.

  16. ENDEAVOR II Conclusions • Sustained clinical benefit out to 5 years with a excellent safety profile with no new (ARC) stent thrombosis events • These long term outcomes could be due in part to the unique biocompatible nature of the PC polymer The Endeavor ZES when compared with the Driver stent demonstrated:

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