Presentation is loading. Please wait.

Presentation is loading. Please wait.

Endeavor 4: A Randomized Comparison of a Zotarolimus- Eluting Stent and a Paclitaxel- Eluting Stent in Patients with Coronary Artery Disease Martin B.

Similar presentations


Presentation on theme: "Endeavor 4: A Randomized Comparison of a Zotarolimus- Eluting Stent and a Paclitaxel- Eluting Stent in Patients with Coronary Artery Disease Martin B."— Presentation transcript:

1 Endeavor 4: A Randomized Comparison of a Zotarolimus- Eluting Stent and a Paclitaxel- Eluting Stent in Patients with Coronary Artery Disease Martin B. Leon, MD Columbia University Medical Center Cardiovascular Research Foundation New York City Monday, October 22, 2007

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

3 Endeavor Clinical Program Overview 9m 2yr 3yr 4yr 9m 2yr 3yr 4yr ENDEAVOR I ENDEAVOR II ENDEAVOR II CA ENDEAVOR III ENDEAVOR IV ENDEAVOR PK Single Arm First-in-Man (n=100) 4yr 1:1 RCT vs. BMS (E=598,D=599) PK (n=106) 3yr Continued Access Single Arm (n=296) 2yr 3:1 RCT vs. Cypher® (E=323,C=113) 2yr 1:1 RCT vs.Taxus® (E=773,T=775) 12mo Pharmacokinetic Study (n=43) 9mo Single Arm (n=99) 9mo ENDEAVOR Japan E-FIVE Open Label Single Arm (n=8000) US Post Approval PROTECT 1:1 RCT vs. Cypher (E=4400,C=4400) Open Label Single Arm Study (n=5000) Proposed Ongoing Premarket Safety and Efficacy Package 25,619 Patients

4 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  g per mm stent length Endeavor IV Clinical Trial Design PI: Martin B. Leon Single De Novo Native Coronary Lesion Vessel Diameter: 2.5–3.5 mm Lesion Length: ≤ 27 mm Pre-dilatation required 1:1 randomization N = 1,548 patients 80 sites US Endeavor Stent n=774 Taxus Stent n=774 30d 6mo 4yr 3yr 2yr 9mo 12mo 8mo 5yr Clinical/MACE Angiography/IVUS QCA and IVUS Subset (328 total = 21.2%)

5 Endeavor IV Patient Flowchart Angio F/U (8 mo) 135/16482.3% Patients Enrolled N = 1548 Randomized Endeavor n = 773 Taxus n = 775 Angio F/U (8 mo) 144/164 87.8% Clinical F/U (9 mo) 758/773 98.1% Clinical F/U (9 mo) 749/77596.6% (12 mo) 749/773 96.9% (12 mo) 741/77595.6%

6 Endeavor IV 8 Month QCA Endeavor (144 pts) Taxus (135 pts) P value RVD (mm) 2.65  0.47 2.68  0.45 0.635 MLD (mm) In-stent 1.95  0.61 2.25  0.61 <0.001 In-segment% DS 1.80  0.55 1.98  0.56 0.008 % DS In-stent 26.41  19.74 16.09  17.99 <0.001 In-segment 32.28  17.02 26.61  15.52 0.004 Late loss (mm) In-stent 0.67  0.49 0.42  0.50 <0.001 In-segment 0.36  0.47 0.23  0.45 0.023

7 Endeavor IV Restenosis at 8 Months (QCA) Endeavor (144 pts) Taxus (135 pts) P value Binary Restenosis - % (#) In-stent 13.3 (19) 6.7 (9) 0.075 Proximal edge 3.6 (5) 3.8 (5) 1.000 Distal edge 0.7 (1) 1.000 In-segment 15.3 (22) 10.4 (14) 0.284

8 Endeavor IV Clinical Events at 30 days Endeavor (770 pts) Taxus (772 pts) P-Value Death (all) – % (#) 0.3 (2) 00.249 Cardiac Cardiac 0.1 (1) 00.499 MI (all) – % (#) 0.8 (6) 2.3 (18) 0.022 Q Wave Q Wave 0.3 (2) 0.1 (1) 0.624 Non Q wave Non Q wave 0.5 (4) 2.2 (17) 0.007 Death (cardiac) + MI (all) – % (#) 0.9 (7) 2.3 (18) 0.042 Stent Thrombosis (all) – % (#) 0.4 (3) 0.1 (1) 0.374 TLR – % (#) 0.4 (3) 0.8 (6) 0.507 TVR (non-TL) – % (#) 0 0.3 (2) 0.500 TVR – % (#) 0.4 (3) 0.9 (7) 0.342 MACE – % (#) 1.2 (9) 3.0 (23) 0.019 TVF – % (#) 1.0 (8) 3.0 (23) 0.010

9 Endeavor IV Primary Endpoint Result at 9 months Target Vessel Failure TVF Rate P for Non-Inferiority < 0.001 Δ=3.8% Taxus(n=54/749)Endeavor(n=50/758) 7.2% 6.6%

10 Endeavor IV Clinical Events at 12 months Endeavorn=749Taxusn=741P-Value Death (all) – % (#) 1.1(8)1.1(8)1.000 Cardiac Cardiac 0.5 (4) 1.000 MI (all) – % (#) 1.6 (12) 2.6 (19) 0.208 Q Wave Q Wave 0.3 (2) 0.1 (1) 1.000 Non Q wave Non Q wave 1.3 (10) 2.4 (18) 0.131 Death (cardiac) + MI (all) – % (#) 2.1 (16) 3.1 (23) 0.260 Stent Thrombosis (all) – % (#) 0.8 (6) 0.1 (1) 0.124 0-30 days 0-30 days 0.4 (3) 0.1 (1) 0.625 31-360days 31-360days 0.4* (3) 00.250 TLR – % (#) 4.5 (34) 3.2 (24) 0.228 TVR (non-TL) – % (#) 2.5 (19) 4.2 (31) 0.085 TVR – % (#) 6.3 (47) 6.7 (50) 0.753 MACE – % (#) 6.5 (49) 6.6 (49) 1.000 TVF – % (#) 7.7 (58) 9.4 (70) 0.267 *Day 83, 145, 171

11 TaxusEndeavor Freedom from TVF 100% 85% 0306090120150180210240270300330360 Time after Initial Procedure (days)TVF030180270360Endeavor773760737712670 Taxus775748721692655 90% 95% TVF-free92.3%90.6%0.243 EndeavorTaxusP (log rank) Endeavor IV TVF Free Survival to 360 days

12 Endeavor IV Target Vessel Revascularization Endeavor (41/758) Taxus (37/749) Endeavor (47/749) Taxus (50/741) P = 0.728 9 months 12 months Rate P = 0.753 5.4% 4.9% 6.3% 6.7%

13 Endeavor IV Target Lesion Revascularization Endeavor (31/758) Taxus (20/749) Endeavor (34/749) Taxus (24/741) P = 0.154 9 months 12 months Rate P = 0.228 4.1% 2.7% 4.5% 3.2%

14 Endeavor IV TLR by Angiographic Follow-up at 12 months TLR Rate 12/141 4/133 22/60820/608 EndeavorTaxusEndeavorTaxus Angiographic Follow-up Clinical Follow-up P =0.070 P =0.875

15 Endeavor IV - Diabetics TVF and TLR at 12 months Rate 20/233 24/223 16/23313/223 EndeavorTaxusEndeavorTaxus P =0.526 P =0.704 8.6% TVF TLR 477 diabetics (30.8% of E IV patients)

16 Endeavor IV TVF – Post Hoc Subgroup Analysis Risk Ratio [95% CI] Risk Ratio EndeavorTaxus P-Value Interaction 0.761.107.9%6.2%8.5%6.9%0.960 Diabetes Non-diabetes 0.821.130.81 7.3%7.2%5.5% 9.0%6.4%6.7%0.479 RVD  2.5mm >2.5 <3.0mm  3.0mm 0.651.190.53 4.4%8.0%5.8% 6.8%6.7%11.0%0.735 Lesion Length  10mm >10 10 <20mm  20mm 1.010.956.2%14.3%6.2%15.1%0.901 Single Stent Multiple Stents 0.1110 Favors Endeavor Favors Taxus

17 The Endeavor DES, compared with the Taxus DES, demonstrated… Endeavor IV Conclusions Reduced peri-procedural non-Q MIs, and a similar overall safety profile (death, Q-MI, and stent thrombosis) through 12 months follow-up Reduced peri-procedural non-Q MIs, and a similar overall safety profile (death, Q-MI, and stent thrombosis) through 12 months follow-up Higher angiographic late loss at 8 months follow-up Higher angiographic late loss at 8 months follow-up Similar TVF (1 ry endpoint) through 12 months follow-up Similar TVF (1 ry endpoint) through 12 months follow-up Similar TVR/TLR in subsets of interest (including diabetics) through 12 months follow-up, especially in the clinical FU patient cohort Similar TVR/TLR in subsets of interest (including diabetics) through 12 months follow-up, especially in the clinical FU patient cohort


Download ppt "Endeavor 4: A Randomized Comparison of a Zotarolimus- Eluting Stent and a Paclitaxel- Eluting Stent in Patients with Coronary Artery Disease Martin B."

Similar presentations


Ads by Google