Document Detail

Maintenance of long-term clinical benefit with sirolimus-eluting coronary stents: three-year results of the RAVEL trial.
MedLine Citation:
PMID:  15723977     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: The use of sirolimus-eluting coronary stents has been associated with a nearly complete elimination of restenosis at 6 months and with a very low 1-year incidence of major adverse cardiac events (MACE). This analysis examined whether these beneficial effects persist over the longer term. METHODS AND RESULTS: This multicenter trial randomly assigned 238 patients to revascularization of single, de novo, native coronary artery lesions with sirolimus-eluting versus conventional bare-metal stents. Survival free from target lesion revascularization (TLR), target vessel failure (TVF), and MACE up to 3 years of follow-up was compared between the 2 treatment groups. Complete data sets were available in 94.2% of patients treated with sirolimus-eluting stents and in 94.1% of patients randomized to the control group. The cumulative 1-, 2-, and 3-year event-free survival rates were 99.2%, 96.5%, and 93.7% for TLR and 95.8%, 92.3%, and 87.9% for TVF, respectively, in the sirolimus-eluting stent group, versus 75.9%, 75.9%, and 75.0% for TLR and 71.2%, 69.4%, and 67.3% for TVF in the control group (P<0.001 for both comparisons at 3 years). Rates of MACE at 3 years were 15.8% in patients randomly assigned to sirolimus-eluting stents versus 33.1% in patients assigned to bare-metal stents (P=0.002). One patient treated with a sirolimus-eluting stent died of a cardiac cause between 12 and 36 months. CONCLUSIONS: Treatment of de novo coronary stenosis with sirolimus-eluting stents was associated with a sustained clinical benefit and very low rates of TLR and of other MACE up to 3 years after device implantation.
Jean Fajadet; Marie-Claude Morice; Christoph Bode; Paul Barragan; Patrick W Serruys; William Wijns; Constantino R Constantini; Jean-Léon Guermonprez; Hélène Eltchaninoff; Didier Blanchard; Antonio Bartorelli; Gert-Jan Laarman; MarcoAntonio Perin; J Eduardo Sousa; Gerhard Schuler; Ferenc Molnar; Giulio Guagliumi; Antonio Colombo; Ernesto Ban Hayashi; Egon Wülfert
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2005-02-21
Journal Detail:
Title:  Circulation     Volume:  111     ISSN:  1524-4539     ISO Abbreviation:  Circulation     Publication Date:  2005 Mar 
Date Detail:
Created Date:  2005-03-01     Completed Date:  2005-09-30     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0147763     Medline TA:  Circulation     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1040-4     Citation Subset:  AIM; IM    
Clinique Pasteur, 45, Avenue du Lombez, 31300 Toulouse, France.
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MeSH Terms
Coronary Restenosis / pathology
Coronary Stenosis / surgery*
Coronary Vessels / pathology*
Double-Blind Method
Follow-Up Studies
Middle Aged
Myocardial Revascularization
Sirolimus / metabolism*
Reg. No./Substance:
Comment In:
Circulation. 2005 Mar 1;111(8):958-60   [PMID:  15738361 ]

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

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