Document Detail

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.
MedLine Citation:
PMID:  20152559     Owner:  NLM     Status:  MEDLINE    
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) < or = 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).
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;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of the American College of Cardiology     Volume:  55     ISSN:  1558-3597     ISO Abbreviation:  J. Am. Coll. Cardiol.     Publication Date:  2010 Feb 
Date Detail:
Created Date:  2010-02-15     Completed Date:  2010-03-16     Revised Date:  2013-08-12    
Medline Journal Info:
Nlm Unique ID:  8301365     Medline TA:  J Am Coll Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  543-54     Citation Subset:  AIM; IM    
Copyright Information:
Copyright 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York, USA.
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MeSH Terms
Coronary Artery Disease / drug therapy*
Drug-Eluting Stents*
Immunosuppressive Agents / administration & dosage*
Middle Aged
Paclitaxel / administration & dosage*
Single-Blind Method
Sirolimus / administration & dosage,  analogs & derivatives*
Treatment Outcome
Reg. No./Substance:
0/Immunosuppressive Agents; 0/zotarolimus; 33069-62-4/Paclitaxel; 53123-88-9/Sirolimus
Comment In:
J Am Coll Cardiol. 2010 Feb 9;55(6):555-7   [PMID:  20152560 ]

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