Document Detail


Real-World Safety and Effectiveness Outcomes of a Zotarolimus-Eluting Stent: Final 3-Year Report of the RESOLUTE International Study.
MedLine Citation:
PMID:  23980808     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
OBJECTIVES: We evaluated the safety and effectiveness of the Resolute™ zotarolimus-eluting stent (R-ZES) in real-world clinical practice through 3 years.
BACKGROUND: A randomized comparison of the R-ZES and the XIENCE V™ everolimus-eluting stent showed no difference in any outcomes through 3-year follow-up in high-volume academic centers. RESOLUTE International is a confirmatory trial designed to evaluate the R-ZES in real-world clinical practice.
METHODS: RESOLUTE International is a single arm, observational trial that enrolled 2,349 patients from 88 centers with only a few inclusion and exclusion criteria. The primary end-point was the composite of cardiac death and target vessel myocardial infarction (TV-MI) at 1 year. Secondary end-points include target lesion failure (TLF), target vessel revascularization (TVR), and their components, and stent thrombosis (ST).
RESULTS: At 3 years 97.2% of patients completed clinical follow-up. The mean age was 63.4 ± 11.2 years, 77.8% were male, and 30.4% had diabetes. The average number of stents per patient was 1.6 ± 1.0; and mean stent length was 30.9 ± 20.5 mm. Dual antiplatelet therapy was used in 91.1% of patients at 1 year, 43.0% at 2 years, and 34.6% at 3 years. Cardiac death and TV-MI occurred in 161 patients (7.0%). There were 6 (0.3%) very late ST events for a total ST rate of 1.1% through 3 years. The rates of clinically driven target lesion revascularization (TLR), TVR, and TLF were 5.7%, 7.4%, and 11.4%, respectively.
CONCLUSIONS: The safety and effectiveness of the R-ZES through 3 years in this real-world all-comer study was consistent with previously reported all-comer trials.
Authors:
Jorge A Belardi; Petr Widimský; Franz-Josef Neumann; Laura Mauri; Mariano Albertal;
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-8-27
Journal Detail:
Title:  Journal of interventional cardiology     Volume:  -     ISSN:  1540-8183     ISO Abbreviation:  J Interv Cardiol     Publication Date:  2013 Aug 
Date Detail:
Created Date:  2013-8-28     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8907826     Medline TA:  J Interv Cardiol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
© 2013 The Authors. Journal of Interventional Cardiology Published by Wiley Periodicals, Inc.
Affiliation:
Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina.
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