Document Detail


A randomized comparison of sirolimus-eluting stent with balloon angioplasty in patients with in-stent restenosis: results of the Restenosis Intrastent: Balloon Angioplasty Versus Elective Sirolimus-Eluting Stenting (RIBS-II) trial.
MedLine Citation:
PMID:  16750678     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: We sought to assess the effectiveness of sirolimus-eluting stents (SES) in patients with in-stent restenosis (ISR). BACKGROUND: Treatment of patients with ISR remains a challenge. METHODS: The Restenosis Intrastent: Balloon Angioplasty Versus Elective Sirolimus-Eluting Stenting (RIBS-II) study is a multicenter randomized trial conducted in 150 patients with ISR (76 allocated to SES and 74 to balloon angioplasty [BA]). The primary end point was recurrent restenosis rate at nine months. Secondary end points included prespecified subgroup analysis, lumen volume on intravascular ultrasound (IVUS), and a composite of major clinical events at one year. RESULTS: Angiographic success was obtained in all patients. At 9-month angiographic follow-up (96% of eligible patients) minimal lumen diameter was larger (2.52 mm [interquartile range (IQR) 2.09 to 2.81] vs. 1.54 mm [IQR 0.91 to 2.05]; p < 0.001) and recurrent restenosis rate was lower (11% vs. 39%; p < 0.001) in the SES group. Prespecified subgroup analyses were consistent with the main outcome measure. Lumen volume on IVUS at 9 months was also larger (279 mm3 [IQR 227 to 300] vs. 197 mm3 [IQR 177 to 230]; p < 0.001) in the SES group. At one-year clinical follow-up (100% of patients), the event-free survival (freedom from death, myocardial infarction, and target vessel revascularization) was significantly improved in the SES group (88% vs. 69%; p < 0.004) as the result of a lower requirement for target vessel revascularization (11% vs. 30%; p < 0.003). CONCLUSIONS: In patients with ISR, the use of SES provides superior long-term clinical, angiographic, and IVUS outcome than BA treatment.
Authors:
Fernando Alfonso; Maria-José Pérez-Vizcayno; Rosana Hernandez; Armando Bethencourt; Vicens Martí; Jose R López-Mínguez; Juan Angel; Ramón Mantilla; Cesar Morís; Angel Cequier; Manel Sabaté; Javier Escaned; Raúl Moreno; Camino Bañuelos; Alfonso Suárez; Carlos Macaya;
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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:  47     ISSN:  1558-3597     ISO Abbreviation:  J. Am. Coll. Cardiol.     Publication Date:  2006 Jun 
Date Detail:
Created Date:  2006-06-05     Completed Date:  2006-06-27     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8301365     Medline TA:  J Am Coll Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2152-60     Citation Subset:  AIM; IM    
Affiliation:
Clinico San Carlos University Hospital, Madrid, Spain. falf@hotmail.com
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MeSH Terms
Descriptor/Qualifier:
Aged
Coronary Angiography
Coronary Restenosis / diagnosis,  etiology,  therapy*
Female
Follow-Up Studies
Humans
Male
Middle Aged
Sirolimus / administration & dosage*,  therapeutic use
Stents* / adverse effects
Treatment Outcome
Ultrasonography, Interventional
Chemical
Reg. No./Substance:
53123-88-9/Sirolimus
Comments/Corrections
Comment In:
J Am Coll Cardiol. 2006 Jun 6;47(11):2161-3   [PMID:  16750679 ]

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


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