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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

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, MD^_*,_*, Laura Mauri, MD, MSc, Jeffrey J. Popma, MD, Donald E. Cutlip, MD^||, Eugenia Nikolsky, MD, PhD^_*, Charles O'Shaughnessy, MD^¶, Paul A. Overlie, MD^#, Brent T. McLaurin, MD, Stuart L. Solomon, MD^_**, John S. Douglas, Jr, MD, Michael W. Ball, MD^||||, Ronald P. Caputo, MD, Ash Jain, MD^¶¶, Thaddeus R. Tolleson, MD, Bernard M. Reen, III, MD, Ajay J. Kirtane, MD^_*, Peter J. Fitzgerald, MD, PhD^##, Kweli Thompson, MD^_***, David E. Kandzari, MD for the ENDEAVOR IV Investigators

^_* Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York
St. Joseph Hospital, Syracuse, New York
Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts
Caritas Cardiovascular Center, St. Elizabeth's Medical Center, Boston, Massachusetts
^|| Beth Israel Deaconess Medical Center, Boston, Massachusetts
^¶ Elyria Memorial Hospital, Elyria, Ohio
^# Lubbock Heart Hospital, Lubbock, Texas
^_** Methodist Hospital, Houston, Texas
Mother Frances Health System, Tyler, Texas
Anderson Medical Center, Anderson, South Carolina
Emory University, Atlanta, Georgia
^|||| Heart Center of Indiana, Indianapolis, Indiana
^¶¶ Washington Hospital, Fremont, California
^## Stanford University, Stanford, California
^_*** Medtronic CardioVascular, Santa Rosa, California
Scripps Clinic, La Jolla, California
Presbyterian Hospital, Charlotte, North Carolina

Manuscript received May 19, 2009; revised manuscript received August 26, 2009, accepted August 30, 2009.

^_* Reprint requests and correspondence: Dr. Martin B. Leon, Columbia University College of Physicians and Surgeons, Center for Interventional Vascular Therapy, New York–Presbyterian Hospital/Columbia University Medical Center, New York, New York 10032 (Email: mleon{at}crf.org).

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 (p_{noninferiority} 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)

Key Words: drug-eluting stents • target lesion revascularization • zotarolimus-eluting stent

Abbreviations and Acronyms   ARC = Academic Research Consortium   DAPT = dual antiplatelet therapy   DES = drug-eluting stent(s)   DS = diameter stenosis   IVUS = intravascular ultrasound   MI = myocardial infarction   PES = paclitaxel-eluting stent(s)   SES = sirolimus-eluting stent(s)   TLR = target lesion revascularization   TVF = target vessel failure   TVR = target vessel revascularization   ZES = zotarolimus-eluting stent(s)

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