Twelve-Month ENDEAVOR IV Outcomes Published

February 17, 2010—Twelve-month outcomes from the ENDEAVOR IV trial have been published by Martin B. Leon, MD, et al in the Journal of the American College of Cardiology (2010;55:543–554).

ENDEAVOR IV is a randomized comparison of the Endeavor zotarolimus-eluting stent (ZES, Medtronic, Inc., Minneapolis, MN) and the Taxus paclitaxel-eluting stent (PES, Boston Scientific Corporation, Natick, MA) in patients with coronary artery disease. The trial evaluated the safety and efficacy of the Endeavor stent compared with the Taxus stent.

According to the ENDEAVOR IV investigators, firstgeneration drug-eluting stents have reduced angiographic and clinical restenosis, but long-term safety remains controversial. Medtronic's second-generation drug-eluting stent, which delivers zotarolimus via a biocompatible phosphorylcholine polymer on a cobaltalloy, thin-strut stent has shown promising experimental and early clinical results.

As detailed by the investigators, this is a prospective, randomized (1:1), single-blind, controlled trial comparing outcomes of patients with single de novo coronary lesions that were treated with either ZES or PES. The primary endpoint was noninferiority of 9-month target vessel failure defined as cardiac death, myocardial infarction, or target vessel revascularization.

The investigators found that among a total of 1,548 patients assigned to ZES (n = 773) or PES (n = 775), at 9 months ZES was noninferior to PES with rates of target vessel failure that were 6.6% versus 7.1%, respectively (Pnoninferiority ≤ .001). There were fewer periprocedural myocardial infarctions with ZES (0.5% vs 2.2%; P = .007), whereas at 12 months, there were no significant differences between groups in the rates of cardiac death, myocardial infarction, target vessel revascularization, or stent thrombosis.

Although incidence of 8-month binary angiographic in-segment restenosis was higher in patients treated with ZES versus PES (15.3% vs 10.4%; P = .284), rates of 12-month target lesion revascularization were similar (4.5% vs 3.2%; P = .228), especially in patients without planned angiographic follow-up (3.6% vs 3.2%; P = .756).

These findings demonstrate that ZES has similar clinical safety and efficacy compared with PES in simpleand medium-complexity single de novo coronary lesions, the investigators concluded.