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Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic AVE ABT-578 Eluting Driver Coronary Stent in De Novo Native Coronary Artery Lesions - ENDEAVOR II: Results Through 4 Years
Description:
The goal of the trial was to evaluate treatment with the Endeavor-eluting stent compared with a bare-metal stent (BMS) among patients undergoing percutaneous coronary intervention (PCI) for single de novo lesions.
Hypothesis:
PCI with the Endeavor-eluting stent would be associated with a reduction in target vessel failure compared with use of a BMS for treatment of single de novo lesions.
Study Design
Study Design:
Patients Enrolled: 1,197
Mean Follow Up: 9 months
Mean Patient Age: 62 years
Female: 24
Patient Populations:
Symptomatic ischemic heart disease due to single de novo stenotic lesions of native coronary arteries
Primary Endpoints:
Target vessel failure at 9 months
Drug/Procedures Used:
Patients were randomized to the Endeavor-eluting stent (n = 598) versus the Driver BMS (n = 599). In a prespecified manner, the initial 600 patients randomized underwent angiographic follow-up at 9 months.
Concomitant Medications:
Aspirin and clopidogrel for 3 months
Principal Findings:
Baseline clinical and angiographic characteristics were similar between the treatment groups, with an average lesion length of 14 mm. Device success (99%) and procedural success (96%) did not differ by treatment group. Culprit artery was the left anterior descending artery in 43% in the Endeavor group and 48% in the BMS group (p = NS).
The primary endpoint of target vessel failure at 9 months was lower in the Endeavor group compared with the BMS group (7.9% vs. 15.1%, p = 0.0001), as was major adverse cardiac events (MACE) (7.3% vs. 14.4%, p = 0.0001). There was no difference in death (1.2% vs. 0.5%), Q-wave myocardial infarction (MI) (0.3% vs. 0.9%), or non-Q-wave MI (2.4% vs. 3.1%). Target lesion revascularization was lower in the Endeavor group (4.6% vs. 11.8%, p = 0.0001), as was target vessel revascularization (5.6% vs. 12.5%, p = 0.0001). Cumulative stent thrombosis was 0.5% versus 1.2% (p = 0.22), respectively.
Among the angiographic cohort, percent stenosis was lower in the Endeavor group compared with the BMS group both in-segment (32.6% vs. 44.4%, p < 0.0001) and in-stent (27.9% vs. 42.3%,p < 0.0001). Binary restenosis was also lower both in-segment (13.2% vs. 35.0%, p < 0.0001) and in-stent (9.4% vs. 33.5%, p < 0.0001), as was late lumen loss in-segment (0.36 mm vs. 0.72 mm, p < 0.0001) and in-stent (0.61 mm vs. 1.03 mm, p < 0.0001).
At 4 years, target vessel revascularization occurred in 10.4% of the Endeavor group versus 21.5% of the Driver group (p < 0.001). Death was 5.0% versus 5.2% (p = 0.90) and nonfatal MI was 3.2% versus 4.4% (p = 0.29), respectively.
Interpretation:
Among patients undergoing PCI for a single de novo lesion, use of the Endeavor-eluting stent was associated with a reduction in target vessel failure at 9 months compared with a Driver BMS. Additionally, the safety profile was good, with a low rate of stent thrombosis. These outcomes appeared to be sustained up to 4 years.
References:
Eisenstein EL, Wijns W, Fajadet J, et al. Long-term clinical and economic analysis of the endeavor drug-eluting stent versus the driver bare-metal stent. 4-year results from the ENDEAVOR II trial (Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic AVE ABT-578 Eluting Driver Coronary Stent in De Novo Native Coronary Artery Lesions). JACC Cardiovasc Interv 2009;2:1178-97.
Fajadet J, et al. Randomized, Double-Blind, Multicenter Study of the Endeavor Zotarolimus-Eluting Phosphorylcholine-Encapsulated Stent for Treatment of Native Coronary Artery Lesions. Circulation 2006;114:798-806.
Presented by Dr. William Wijns at the March 2005 ACC Annual Scientific Session, Orlando, FL.
Keywords: Myocardial Infarction, Coronary Restenosis, Metals, Thrombosis, Constriction, Pathologic, Coronary Vessels, Sirolimus, Stents, Percutaneous Coronary Intervention
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