Randomized study to evaluate sirolimus-eluting stents implanted at coronary bifurcation lesions

Area of Science:

• Interventional Cardiology
• Cardiovascular Devices
• Medical Technology

Background:

• Sirolimus-eluting stents (Cypher) effectively reduce restenosis in select coronary lesions.
• Higher-risk lesions, such as coronary bifurcations, have not been extensively studied with these stents.

Purpose of the Study:

• To evaluate the safety and efficacy of sirolimus-eluting stents in treating coronary bifurcation lesions.
• To compare two stenting strategies: double stenting versus main branch stenting with provisional side branch stenting.

Main Methods:

• Prospective study enrolling 85 patients (86 lesions) with coronary bifurcation lesions.
• Random assignment to either double stenting (Group A) or main branch with provisional side branch stenting (Group B).
• Clinical and angiographic follow-up at 6 months.

Main Results:

• Overall restenosis rate at 6 months was 25.7%, not significantly different between groups (double stenting 28.0%, provisional SB-stenting 18.7%).
• Stent thrombosis occurred in 3.5% of patients.
• Target lesion revascularization in 7 cases and target vessel failure in 17.6%.

Conclusions:

• Sirolimus-eluting stent use in bifurcations shows improvement over historical bare metal stent controls.
• Restenosis at the side branch ostium remains a significant challenge.
• The optimal technique for treating bifurcations with Cypher stents requires further investigation.