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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, for the Gruppo Italiano di Studio sullo Stent nelle Occlusioni Coronariche (GISSOC II) GISE Investigators, 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, European Heart Journal, Volume 31, Issue 16, August 2010, Pages 2014–2020, https://doi.org/10.1093/eurheartj/ehq199
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Abstract
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.
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).
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
- angiogram
- myocardial infarction
- clopidogrel
- percutaneous coronary intervention
- stents
- restenosis
- coronary occlusion
- rapamycin
- cardiac event
- constriction, pathologic
- erythema chronicum migrans
- follow-up
- phenobarbital
- treatment outcome
- recanalization
- metallic stents
- drug-eluting stents
- revascularization
- surrogate endpoints
- diameter