Document Detail

2-year clinical and angiographic outcomes from a randomized trial of polymer-free dual drug-eluting stents versus polymer-based Cypher and Endeavor [corrected] drug-eluting stents.
MedLine Citation:
PMID:  20417052     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: In the ISAR-TEST-2 (Intracoronary Stenting and Angiographic Results: Test Efficacy of Three Limus-Eluting Stents) randomized trial, a new-generation sirolimus- and probucol-eluting stent (Dual-DES) demonstrated a 12-month efficacy that was comparable to sirolimus-eluting stents (SES) (Cypher, Cordis Corp., Warren, New Jersey) and superior to zotarolimus-eluting stents (ZES) (Endeavor, Medtronic CardioVascular, Santa Rosa, California). The aim of the current study was to investigate the comparative clinical and angiographic effectiveness of SES, Dual-DES, and ZES between 1 and 2 years. BACKGROUND: Long-term polymer residue is implicated in adverse events associated with delayed vessel healing after drug-eluting stent therapy. The second-generation ZES utilizes an enhanced biocompatibility polymer system whereas a new-generation Dual-DES employs a polymer-free drug-release system. METHODS: A total of 1,007 patients undergoing coronary stenting of de novo lesions in native vessels were randomized to treatment with SES (n = 335), Dual-DES (n = 333), or ZES (n = 339). Clinical follow-up was performed to 2 years. Angiographic follow-up was scheduled at 6 to 8 months and 2 years. RESULTS: There were no significant differences between groups regarding death/myocardial infarction (SES: 10.2% vs. Dual-DES: 7.8% vs. ZES: 9.2%; p = 0.61) or definite stent thrombosis (SES: 0.9% vs. Dual-DES: 0.9% vs. ZES: 0.6%; p = 0.87). Two-year target lesion revascularization (TLR) was 10.7%, 7.7%, and 14.3% lesions in the SES, Dual-DES, and ZES groups, respectively (p = 0.009). Incident TLR between 1 and 2 years in the Dual-DES group (0.9%) was significantly lower than in the Cypher SES group (3.6%) (p = 0.009), but comparable to the Endeavor ZES group (0.7%) (p = 0.72). These findings mirrored those observed for binary restenosis. CONCLUSIONS: At 2 years, there was no signal of a differential safety profile between the 3 stent platforms. Furthermore, the antirestenotic efficacy of both Dual-DES and ZES remained durable between 1 and 2 years, with Dual-DES maintaining an advantage over the entire 2-year period. (Intracoronary Stenting and Angiographic Results: Test Efficacy of Three Limus-Eluting Stents [ISAR-TEST-2]; NCT00332397).
Robert A Byrne; Adnan Kastrati; Klaus Tiroch; Stefanie Schulz; Jürgen Pache; Susanne Pinieck; Steffen Massberg; Melchior Seyfarth; Karl-Ludwig Laugwitz; Katrin A Birkmeier; Albert Schömig; Julinda Mehilli;
Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2010-04-22
Journal Detail:
Title:  Journal of the American College of Cardiology     Volume:  55     ISSN:  1558-3597     ISO Abbreviation:  J. Am. Coll. Cardiol.     Publication Date:  2010 Jun 
Date Detail:
Created Date:  2010-06-01     Completed Date:  2010-07-01     Revised Date:  2010-08-30    
Medline Journal Info:
Nlm Unique ID:  8301365     Medline TA:  J Am Coll Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2536-43     Citation Subset:  AIM; IM    
Copyright Information:
Copyright 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Deutsches Herzzentrum, Technische Universität, Munich, Germany.
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MeSH Terms
Angioplasty, Transluminal, Percutaneous Coronary / adverse effects,  instrumentation*,  methods
Coronary Angiography
Coronary Restenosis / mortality,  pathology,  radiography*
Coronary Stenosis / mortality,  radiography*,  therapy*
Coronary Vessels / drug effects
Drug-Eluting Stents*
Follow-Up Studies
Prospective Studies
Prosthesis Design
Prosthesis Failure
Risk Assessment
Severity of Illness Index
Sirolimus / pharmacology
Survival Analysis
Time Factors
Treatment Outcome
Reg. No./Substance:
0/Polymers; 53123-88-9/Sirolimus
Comment In:
Nat Rev Cardiol. 2010 Sep;7(9):475
Erratum In:
J Am Coll Cardiol. 2010 Jul 13;56(3):243

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