Document Detail


Comparison of zotarolimus-eluting stents with sirolimus- and paclitaxel-eluting stents for coronary revascularization: the ZEST (comparison of the efficacy and safety of zotarolimus-eluting stent with sirolimus-eluting and paclitaxel-eluting stent for coronary lesions) randomized trial.
MedLine Citation:
PMID:  20883925     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: The aim of this study was to evaluate the relative efficacy and safety of zotarolimus-eluting stents (ZES) in comparison with the established and widely used sirolimus- (SES) and paclitaxel-eluting stents (PES) in routine clinical practice.
BACKGROUND: Whether ZES might provide similar clinical and angiographic outcomes in a broad spectrum of patients compared with SES or PES is undetermined.
METHODS: We performed a single-blind, multicenter, prospectively randomized trial to compare ZES with SES and PES in 2,645 patients undergoing percutaneous coronary intervention. The primary end point was a composite of major adverse cardiac events (MACE) (death, myocardial infarction, and ischemia-driven target vessel revascularization) at 12 months. A noninferiority comparison (ZES vs. SES) and a superiority comparison (ZES vs. PES) were performed for the primary end point.
RESULTS: Baseline clinical and angiographic characteristics were similar in the 3 groups. At 12 months, the ZES group showed noninferior rates of MACE compared with the SES group (10.2% vs. 8.3%, p for noninferiority = 0.01, p for superiority = 0.17) and significantly fewer MACE than the PES group (10.2% vs. 14.1%, p for superiority = 0.01). The incidence of death or myocardial infarction was similar among the groups (ZES vs. SES vs. PES, 5.8% vs. 6.9% vs. 7.6%, respectively, p = 0.31). The incidence of stent thrombosis was significantly lower in the SES group (ZES vs. SES vs. PES, 0.7% vs. 0% vs. 0.8%, respectively, p = 0.02).
CONCLUSIONS: In this large-scale, practical randomized trial, the use of ZES resulted in similar rates of MACE compared with SES and in fewer MACE compared with PES at 12 months. (Comparison of the Efficacy and the Safety of Zotarolimus-Eluting Stent Versus Sirolimus-Eluting Stent and PacliTaxel-Eluting Stent for Coronary Lesions; NCT00418067).
Authors:
Duk-Woo Park; Young-Hak Kim; Sung-Cheol Yun; Soo-Jin Kang; Seung-Whan Lee; Cheol-Whan Lee; Seong-Wook Park; In-Whan Seong; Jae-Hwan Lee; Seung-Jea Tahk; Myung-Ho Jeong; Yangsoo Jang; Sang-Sig Cheong; Joo-Young Yang; Do-Sun Lim; Ki-Bae Seung; Jei-Keon Chae; Seung-Ho Hur; Sang-Gon Lee; Junghan Yoon; Nae-Hee Lee; Young-Jin Choi; Hyun-Sook Kim; Kee-Sik Kim; Hyo-Soo Kim; Taeg-Jong Hong; Hun-Sik Park; Seung-Jung Park
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  Journal of the American College of Cardiology     Volume:  56     ISSN:  1558-3597     ISO Abbreviation:  J. Am. Coll. Cardiol.     Publication Date:  2010 Oct 
Date Detail:
Created Date:  2010-10-04     Completed Date:  2010-10-22     Revised Date:  2011-05-24    
Medline Journal Info:
Nlm Unique ID:  8301365     Medline TA:  J Am Coll Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1187-95     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Affiliation:
Department of Cardiology, Center for Medical Research and Information, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00418067
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MeSH Terms
Descriptor/Qualifier:
Aged
Cardiovascular Diseases / etiology,  mortality
Coronary Restenosis / etiology,  mortality
Drug-Eluting Stents* / adverse effects
Female
Follow-Up Studies
Humans
Male
Middle Aged
Myocardial Reperfusion / adverse effects,  instrumentation*
Paclitaxel / administration & dosage*,  adverse effects
Prospective Studies
Single-Blind Method
Sirolimus / administration & dosage*,  adverse effects,  analogs & derivatives*
Treatment Outcome
Chemical
Reg. No./Substance:
0/zotarolimus; 33069-62-4/Paclitaxel; 53123-88-9/Sirolimus
Comments/Corrections
Comment In:
J Am Coll Cardiol. 2011 Apr 12;57(15):1635-6; author reply 1636   [PMID:  21474045 ]

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