ENDEAVOR IV ENDEAVOR IV Two-Year Follow-up from a Prospective Two-Year Follow-up from a Prospective Randomized Trial Comparing a Randomized Trial Comparing a Zotarolimus-Eluting Stent and a Zotarolimus-Eluting Stent and a Paclitaxel-Eluting Stent in Patients with Paclitaxel-Eluting Stent in Patients with Coronary Artery Disease Coronary Artery Disease Martin B. Leon, MD for the Endeavor IV investigators Columbia University Medical Center Columbia University Medical Center Cardiovascular Research Foundation Cardiovascular Research Foundation New York City New York City Tuesday, October 14, 2008 Tuesday, October 14, 2008
ENDEAVOR IV – 2yr FU ENDEAVOR IV – 2yr FU Clinical Trial Design Clinical Trial Design PI: Martin B. Leon PI: Martin B. Leon Single De Novo De Novo Native Coronary Lesion Native Coronary Lesion Single Vessel Diameter: 2.5–3.5 mm Vessel Diameter: 2.5–3.5 mm Lesion Length: ≤ 27 mm Lesion Length: ≤ 27 mm Pre-dilatation required Pre-dilatation required 1:1 randomization Endeavor Stent Taxus Stent N = 1,548 patients 80 sites n = 774 n = 774 US Clinical/MACE Clinical/MACE 30d 6mo 8mo 9mo 12mo 2yr 3yr 4yr 5yr Angiography/IVUS Angiography/IVUS QCA and IVUS QCA and IVUS Subset Subset (328 total = 21.2%) (328 total = 21.2%) Primary Endpoint: TVF at 9 months Secondary Endpoints: In-segment % DS at 8 months; TLR and TVR at 9 months Drug Therapy: ASA and Clopidogrel/Ticlid >6 months Zotarolimus Dose: 10 µ g per mm stent length
ENDEAVOR IV – 2yr FU ENDEAVOR IV – 2yr FU TVF to 24 months (1 ry ry endpt) endpt) TVF to 24 months (1 2-year HR 1-year HR 0.83 [0.62, 1.12] 15% 0.79 [0.56, 1.12] Endeavor P = 0.220 Cumulative Incidence for TVF P = 0.188 Taxus 13.1% 9.5% 11.1% 10% ∆2.0% 2.0% ∆ 7.7% 5% ∆1.8% 1.8% ∆ 0% 90 180 270 360 450 540 630 720 0 Time after Initial Procedure (days) Endeavor 773 769 749 736 700 674 653 645 635 Taxus 775 755 738 717 690 660 642 633 625
ENDEAVOR IV – 2yr FU ENDEAVOR IV – 2yr FU TLR to 24 months TLR to 24 months 15% Cumulative Incidence for TLR Endeavor Taxus 1-year HR 2-year HR 10% 1.42 [0.84, 2.39] 1.30 [0.83, 2.04] P = 0.188 P = 0.255 6.0% 4.5% 5% 4.7% 3.2% ∆1.3% 1.3% ∆ ∆1.3% 1.3% ∆ 0% 0 90 180 270 360 450 540 630 720 Time after Initial Procedure (days) Endeavor 773 773 755 744 706 684 666 661 654 Taxus 775 771 757 740 708 687 668 663 660
ENDEAVOR IV – 2yr FU ENDEAVOR IV – 2yr FU Safety Endpoints to 24 months Safety Endpoints to 24 months Endeavor (n=742) Taxus (n=739) P =0.096 P =0.096 5.1% P =0.023 P =0.022 4.1% 3.5% 3.4% Rate Rate P =0.823 P =0.823 2.0% 1.6% 1.5% P =0.725 P =0.725 1.2% 0.5% 0.4% Cardiac MI All Q-wave Non-Q Cardiac Death Cardiac MI All Q-wave Non-Q Cardiac Death Death and MI Death and MI
ENDEAVOR IV – 2yr FU ARC ST 12-24 mos Endeavor (n=742) Taxus (n=739) P =0.069 P =0.069 P =0.124 P =0.124 P =0.499 P =0.499 0.8% P =1.000 P =1.000 0.7% Rate Rate 0.4% 0.3% 0.1% 0.1% 0.1% 0.0% n=1 n=5 n=3 n=1 n=1 n=2 n=6 ARC Definite ARC Definite ARC Probable ARC Probable ARC Definite ARC Definite ARC Possible ARC Possible Probable Probable
ENDEAVOR IV – 2yr FU ARC Def/Prob ST 12-24 mos (VLST) Definite/ Time Clinical DAPT at DES Probable (Days) Event event TAXUS Definite 413 QMI ASA Only TAXUS Definite 495 NQMI ASA + Clopidogrel TAXUS Definite 619 NQMI ASA + Clopidogrel TAXUS Definite 645 QMI ASA Only TAXUS Definite 689 NQMI ASA + Clopidogrel TAXUS Probable 697 QMI ASA + Clopidogrel Endeavor Definite 369 QMI None
ENDEAVOR IV – 2yr FU ARC Def/Prob ST and MI 12-24 mos ARC Definite/Probable ST Myocardial Infarction 2% 2% Def/Prob Thrombosis (ARC) Endeavor Cumulative Incidence of MI Endeavor 1-2year 1-2year Taxus P = 0.06 P = 0.11 Taxus 1% 1% 0% 0% 720 360 450 540 630 720 360 450 540 630 End 726 726 709 705 699 End 726 726 707 703 697 Tax 725 725 706 703 699 Tax 725 725 706 702 697
ENDEAVOR IV – 2yr FU Timing of ARC Def/Prob ST 697 689 Taxus Taxus 645 619 495 413 2 369 171 Endeavor Endeavor 145 130 83 2 2 1 0 60 120 180 240 300 360 420 480 540 600 660 720 Days after procedure Days after procedure
ENDEAVOR IV – 2yr FU Timing of ARC Def/Prob ST 697 689 Taxus Taxus 20 645 619 495 413 53 2 369* 10 171 Endeavor Endeavor 43 145 Off DAPT Off DAPT 130 83 2 2 * Off both ASA and Clopidogrel 1 0 60 120 180 240 300 360 420 480 540 600 660 720 Days after procedure Days after procedure
ENDEAVOR IV In Perspective ARC Def/Prob ST Landmark Analysis 2.5% 1 Yr 2 Yrs 3 Yrs 4 Yrs Endeavor EIV 739 693 NA NA 2.0% ARC (ef/Prob ST Endeavor Pooled 2068 2036 1650 1087 1.5% 1.0% 0.9% 0.9% 95% CI 95% CI 95% CI 95% CI 95% CI 95% CI 0.6% [0.00-0.25] [0.00-0.29] [0.00-0.32] 0.6% [0.00-0.25] [0.00-0.29] [0.00-0.32] 0.5% 95% CI 95% CI 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% 0.1% [0.00-0.95] [0.00-0.95] 0.0% 0 360 720 1080 1440 Days
ENDEAVOR IV – 2yr FU ENDEAVOR IV – 2yr FU Conclusions Conclusions Between 12 and 24 mos FU, the Endeavor DES, Between 12 and 24 mos FU, the Endeavor DES, compared with the Taxus DES, demonstrated… compared with the Taxus DES, demonstrated… • Efficacy Efficacy Continued similar TLR and TVR, even in high Continued similar TLR and TVR, even in high restenosis risk subgroups (e.g. diabetics) and restenosis risk subgroups (e.g. diabetics) and especially in the patients with only clinical FU especially in the patients with only clinical FU • Safety Safety Reduced ARC def/prob very late stent Reduced ARC def/prob very late stent thrombosis (P=0.059; 1 vs. 6 events), even in thrombosis (P=0.059; 1 vs. 6 events), even in the setting of frequent DAPT use the setting of frequent DAPT use Reduced all MIs (P=0.023), linked to the Reduced all MIs (P=0.023), linked to the decrease in very late stent thrombosis events decrease in very late stent thrombosis events Safety findings consistent with the larger Safety findings consistent with the larger pooled analysis of Endeavor studies pooled analysis of Endeavor studies
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