Author + information
- Received May 19, 2009
- Revision received August 26, 2009
- Accepted August 30, 2009
- Published online February 9, 2010.
- 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†††,
- ENDEAVOR IV Investigators
- ↵*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
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)
The ENDEAVOR IV clinical trial was funded by Medtronic CardioVascular, Santa Rosa, California. Dr. Leon has served as a consultant to Volcano Corporation, Abbott Vascular, Boston Scientific, Cordis, and Medtronic, Inc. Dr. Mauri has served as a consultant to Abbott, Boston Scientific, Cordis, and Medtronic, Inc. Dr. Popma has received research grants from Cordis, Boston Scientific, Medtronic, Abbott Vascular, Biosensors, and ev3; has served as a consultant for Medtronic, Boston Scientific, Cordis, Abbott Vascular, and Lilly; and has served as a speaker for Pfizer, Bristol-Myers Squibb, Sanofi, Lilly, Boston Scientific, Medtronic, Cordis, and The Medicines Co. Dr. O'Shaughnessy has received research grants from Medtronic, Inc.and Boston Scientific, and is on the advisory board and Speakers' Bureau of Boston Scientific. Dr. Overlie has served as a clinical investigator for Abbott Vascular, Boston Scientific, Cordis, and Medtronic, Inc. Dr. Solomon is a registered speaker for the Medtronic Corporation. Dr. Douglas is a research investigator for Medtronic, Cordis, Boston Scientific, St. Jude, and Abbott. Dr. Caputo is a consultant to Boston Scientific and Cordis, and is on the Speakers' Bureau of Medtronic and Abbott. Dr. Kirtane has served as a consultant and speaker for Medtronic CardioVascular, Abbott Vascular, and Boston Scientific. Dr. Fitzgerald has served as a consultant for Abbott, Boston Scientific, Cordis, EndoTex, St. Jude Medical, Biosensor, ev3, Medtronic, Inc., GlaxoSmithKline, XTENT, ATI, Volcano Corporation, Novadaq, AorTx, CardioMind, Cytograft Tissue Engineering, FlowCardia, Cardio-Optics, Optics, CardioMind, RTI Medical, SurModics, Hospira, and CatherosMed. Dr. Thompson is a full-time employee and stockholder of Medtronic CardioVascular. Dr. Kandzari receives research/grant support and consulting honoraria from Medtronic CardioVascular, Inc.and Cordis Corporation.
- Received May 19, 2009.
- Revision received August 26, 2009.
- Accepted August 30, 2009.
- American College of Cardiology Foundation