| 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. | |
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MedLine Citation:
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PMID: 16750678 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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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:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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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:
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Created Date: 2006-06-05 Completed Date: 2006-06-27 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 8301365 Medline TA: J Am Coll Cardiol Country: United States |
Other Details:
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Languages: eng Pagination: 2152-60 Citation Subset: AIM; IM |
Affiliation:
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Clinico San Carlos University Hospital, Madrid, Spain. falf@hotmail.com |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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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:
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53123-88-9/Sirolimus |
| Comments/Corrections | |
Comment In:
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J Am Coll Cardiol. 2006 Jun 6;47(11):2161-3
[PMID:
16750679
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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