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.

Abstract

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.

• Authors: Paolo Rubartelli, Anna Sonia Petronio, Vincenzo Guiducci, Paolo Sganzerla, Leonardo Bolognese, Mario Galli, Imad Sheiban, Fabio Chirillo, Angelo Ramondo, Sandro Bellotti, Gruppo Italiano di Studio sullo Stent nelle Occlusioni Coronariche II GISE Investigators
• Journal: European heart journal (Eur Heart J) Vol. 31 Issue 16 Pg. 2014-20 (Aug 2010) ISSN: 1522-9645 [Electronic] England
• PMID: 20566487 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Immunosuppressive Agents
• Sirolimus

Topics

• Coronary Angiography
• Coronary Occlusion (diagnostic imaging, drug therapy)
• Drug-Eluting Stents
• Female
• Humans
• Immunosuppressive Agents (administration & dosage)
• Italy
• Male
• Middle Aged
• Sirolimus (administration & dosage)
• Stents
• Treatment Outcome