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.

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
Abstract/OtherAbstract:	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).

Authors:	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;
Related Documents :	11923799 - Natural history of small and medium-sized side branches after coronary stent implantation. 14766319 - Patent ductus arteriosus remodels cardiac sensory neuronal chemotransduction. 16049279 - Coronary artery stents: identification and evaluation. 1760709 - Quantitative measure of small vessel anastomotic contour using corrosion resin cast mod... 16904209 - Five-year outcomes after stenting of unprotected left main coronary artery stenosis in ... 11981719 - Description of a reusable device for the temporary stenting of the open sternum. 15071249 - Effectiveness of rapid atrial pacing for termination of drug refractory atrial fibrilla... 3758089 - Relation between power spectrum time course during ventricular fibrillation and electro... 16620349 - Management and outcomes of acute coronary syndrome with minimal myocardial necrosis: an...
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: -
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.
Affiliation:	Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York, USA. mleon@crf.org
Data Bank Information
Bank Name/Acc. No.:	ClinicalTrials.gov/NCT00217269
Export Citation:	APA/MLA Format Download EndNote Download BibTex
MeSH Terms
Descriptor/Qualifier:	Aged Coronary Artery Disease / drug therapy* Drug-Eluting Stents* Female Humans Immunosuppressive Agents / administration & dosage* Male Middle Aged Paclitaxel / administration & dosage* Single-Blind Method Sirolimus / administration & dosage, analogs & derivatives* Treatment Outcome
Chemical
Reg. No./Substance:	0/Immunosuppressive Agents; 0/zotarolimus; 33069-62-4/Paclitaxel; 53123-88-9/Sirolimus
Comments/Corrections
Comment In:	J Am Coll Cardiol. 2010 Feb 9;55(6):555-7 [PMID: 20152560 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

Previous Document: Endovascular stenting for vertebral artery stenosis.
Next Document: A double-blind, randomized study on prevention and existence of a rebound phenomenon of platelets af...