| Comparison of sirolimus-eluting and bare metal stent for treatment of patients with total coronary occlusions: results of the GISSOC II-GISE multicentre randomized trial. | |
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MedLine Citation:
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PMID: 20566487 Owner: NLM Status: In-Process |
Abstract/OtherAbstract:
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AIMS: Percutaneous coronary intervention with bare metal stent (BMS) in chronic total coronary occlusions (CTOs) is associated with a higher rate of angiographic restenosis and reocclusion than that observed in subtotal stenoses. Preliminary reports have suggested a better performance of drug-eluting stents in CTO. In this multicentre, randomized trial, we compared the mid-term angiographic and clinical outcome of sirolimus-eluting stent (SES) or BMS implantation after successful recanalization of CTO. METHODS AND RESULTS: Patients with CTO older than 1 month, after successful recanalization, were randomized to implantation of SES (78 patients) or BMS (74 patients) in 13 Italian centres. Clopidogrel therapy was prescribed for 6 months. The primary endpoint was in-segment minimal luminal diameter (MLD) at 8-month follow-up. Secondary clinical endpoints included death, myocardial infarction (MI), target lesion revascularization (TLR), and target vessel revascularization (TVR) at 24 months. Patients treated with SES showed, at in-segment analysis, a larger MLD (1.98 +/- 0.57 vs. 0.98 +/- 0.80 mm, P < 0.001), a lower late luminal loss (-0.06 +/- 0.49 vs. 1.11 +/- 0.79 mm, P < 0.001), and lower restenosis (9.8 vs. 67.7%, P < 0.001) and reocclusion (0 vs. 17%, P = 0.001) rates. At 24-month follow-up, patients in the SES group experienced fewer major adverse cardiac events (50.0 vs. 17.6%, P < 0.001) mainly due to a lower rate of both TLR (44.9 vs. 8.1%, P < 0.001) and TVR (44.9 vs. 14.9%, P < 0.001). CONCLUSION: In CTO, SES is markedly superior to BMS in terms of restenosis and reocclusion rate, and incidence of repeat revascularization at 24 months. Clinicaltrials.gov identifier: NCT00220558. |
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Authors:
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Paolo Rubartelli; Anna Sonia Petronio; Vincenzo Guiducci; Paolo Sganzerla; Leonardo Bolognese; Mario Galli; Imad Sheiban; Fabio Chirillo; Angelo Ramondo; Sandro Bellotti; |
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Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't Date: 2010-06-20 |
Journal Detail:
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Title: European heart journal Volume: 31 ISSN: 1522-9645 ISO Abbreviation: Eur. Heart J. Publication Date: 2010 Aug |
Date Detail:
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Created Date: 2010-08-16 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8006263 Medline TA: Eur Heart J Country: England |
Other Details:
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Languages: eng Pagination: 2014-20 Citation Subset: IM |
Affiliation:
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Dipartimento di Cardiologia, Ospedale Villa Scassi, Corso Scassi 1, 16149 Genova, Italy. paolo.rubartelli@villascassi.it |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00220558 |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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