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ENDEAVOR II Five-Year Clinical Follow-up

Ian T. Meredith, MBBS, PhD MonashHEART Monash Medical Centre Melbourne, Australia On Behalf of the Endeavor II Investigators. ENDEAVOR II Five-Year Clinical Follow-up. Potential Conflicts Of Interest. Speaker’s name: Ian T. Meredith

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ENDEAVOR II Five-Year Clinical Follow-up

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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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