Document Detail

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.
MedLine Citation:
PMID:  20566487     Owner:  NLM     Status:  In-Process    
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. identifier: NCT00220558.
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:
Type:  Journal Article; Research Support, Non-U.S. Gov't     Date:  2010-06-20
Journal Detail:
Title:  European heart journal     Volume:  31     ISSN:  1522-9645     ISO Abbreviation:  Eur. Heart J.     Publication Date:  2010 Aug 
Date Detail:
Created Date:  2010-08-16     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8006263     Medline TA:  Eur Heart J     Country:  England    
Other Details:
Languages:  eng     Pagination:  2014-20     Citation Subset:  IM    
Dipartimento di Cardiologia, Ospedale Villa Scassi, Corso Scassi 1, 16149 Genova, Italy.
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