Document Detail

Long-term clinical benefit of sirolimus-eluting stents in patients with in-stent restenosis results of the RIBS-II (Restenosis Intra-stent: Balloon angioplasty vs. elective sirolimus-eluting Stenting) study.
MedLine Citation:
PMID:  18992651     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: We sought to assess the long-term effectiveness and safety of sirolimus-eluting stents (SES) in patients with in-stent restenosis (ISR). BACKGROUND: Treatment of patients with ISR remains a challenge. The long-term outcome of patients with ISR treated with SES remains unknown. METHODS: The RIBS-II (Restenosis Intra-stent: Balloon angioplasty vs. elective sirolimus-eluting Stenting) study was a randomized trial conducted in 150 patients with ISR (76 SES, 74 balloon angioplasty [BA]). The long-term (>1 year) clinical outcome and pre-specified subgroup analyses were pre-defined secondary study end points. RESULTS: At 1 year, the event-free survival (death, myocardial infarction, target vessel revascularization [TVR]) was better in the SES group (88% vs. 69%, p < 0.005). Additional long-term (>3 years) clinical follow-up was obtained in 97% of patients (median 3.3 years). After the first year, 3 patients died (1 SES, 2 BA), 5 suffered myocardial infarction (4 SES, 1 BA), and 7 required TVR (4 SES, 3 BA). At last follow-up, definitive/probable/possible stent thrombosis was similar in both groups (2/2/1 SES vs. 1/0/3 BA, p = NS). At 4 years, the event-free survival was 76% in the SES arm and 65% in the BA arm (p = 0.019). On multivariate analysis, SES implantation was an independent predictor of event-free survival. Subgroup analyses were consistent with the main outcome measure. CONCLUSIONS: In patients with ISR, SES implantation remains effective and safe at very long-term clinical follow-up.
Fernando Alfonso; María-José Pérez-Vizcayno; Rosana Hernández; Armando Bethencourt; Vicens Martí; José R López-Mínguez; Juan Angel; Andrés Iñiguez; César Morís; Angel Cequier; Manel Sabaté; Javier Escaned; Pilar Jiménez-Quevedo; Camino Bañuelos; Alfonso Suárez; Carlos Macaya;
Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  Journal of the American College of Cardiology     Volume:  52     ISSN:  1558-3597     ISO Abbreviation:  J. Am. Coll. Cardiol.     Publication Date:  2008 Nov 
Date Detail:
Created Date:  2008-11-10     Completed Date:  2008-12-04     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8301365     Medline TA:  J Am Coll Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1621-7     Citation Subset:  AIM; IM    
University Hospital, Clinico San Carlos, Madrid, Spain.
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MeSH Terms
Angioplasty, Transluminal, Percutaneous Coronary*
Antibiotics, Antineoplastic / administration & dosage*
Coronary Restenosis / therapy*
Coronary Thrombosis / etiology
Drug-Eluting Stents*
Follow-Up Studies
Platelet Aggregation Inhibitors / therapeutic use
Postoperative Complications / etiology
Prospective Studies
Sirolimus / administration & dosage*
Ticlopidine / analogs & derivatives,  therapeutic use
Reg. No./Substance:
0/Antibiotics, Antineoplastic; 0/Platelet Aggregation Inhibitors; 53123-88-9/Sirolimus; 55142-85-3/Ticlopidine; 90055-48-4/clopidogrel

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