A Randomized Comparison of the Endeavor Zotarolimus-Eluting Stent Versus the TAXUS Paclitaxel-Eluting Stent in De Novo Native Coronary Lesions. 12-Month Outcomes From the ENDEAVOR IV Trial

Martin B. Leon, Laura Mauri, Jeffrey J. Popma, Donald E. Cutlip, Eugenia Nikolsky, Charles O'Shaughnessy, Paul A. Overlie, Brent T. McLaurin, Stuart L. Solomon, John S. Douglas, Michael W. Ball, Ronald P. Caputo, Ash Jain, Thaddeus R. Tolleson, Bernard M. Reen, Ajay J. Kirtane, Peter J. Fitzgerald, Kweli Thompson, David E. Kandzari

Research output: Contribution to journalArticle

203 Scopus citations

Abstract

Objectives: The ENDEAVOR IV (Randomized Comparison of Zotarolimus-Eluting and Paclitaxel-Eluting Stents in Patients with Coronary Artery Disease) trial evaluated the safety and efficacy of the zotarolimus-eluting stent (ZES) compared with the paclitaxel-eluting stent (PES). Background: First-generation drug-eluting stents have reduced angiographic and clinical restenosis, but long-term safety remains controversial. A second-generation drug-eluting stent, which delivers zotarolimus, a potent antiproliferative agent, via a biocompatible phosphorylcholine polymer on a cobalt alloy thin-strut stent has shown promising experimental and early clinical results. Methods: This is a prospective, randomized (1:1), single-blind, controlled trial comparing outcomes of patients with single de novo coronary lesions treated with ZES or PES. The primary end point was noninferiority of 9-month target vessel failure defined as cardiac death, myocardial infarction, or target vessel revascularization. Results: 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 6.6% versus 7.1%, respectively (pnoninferiority ≤ 0.001). There were fewer periprocedural myocardial infarctions with ZES (0.5% vs. 2.2%; p = 0.007), whereas at 12 months, there were no significant differences between groups in 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 = 0.284), rates of 12-month target lesion revascularization were similar (4.5% vs. 3.2%; p = 0.228), especially in patients without planned angiographic follow-up (3.6% vs. 3.2%; p = 0.756). Conclusions: These findings demonstrate that ZES has similar clinical safety and efficacy compared with PES in simple and medium complexity single de novo coronary lesions. (ENDEAVOR IV Clinical Trial; NCT00217269).

Original languageEnglish (US)
Pages (from-to)543-554
Number of pages12
JournalJournal of the American College of Cardiology
Volume55
Issue number6
DOIs
StatePublished - Feb 9 2010

Keywords

  • drug-eluting stents
  • target lesion revascularization
  • zotarolimus-eluting stent

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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