Long term clinical outcomes of sirolimus eluting-stents for the treatment of small coronary arteries

Abstract

Background: Sirolimus-eluting stents have proved to be effective in reducing restenosis in comparison with bare-metal stents in a highly challenging condition such as the percutaneous revascularization of small coronary arteries. However, long-term clinical outcomes in such patients treated with a sirolimus-eluting stent have not yet been investigated. Methods and Results: The long-term SES-SMART clinical study was a randomized, multicenter, single-blind, prospective study of 257 patients treated with a sirolimus-eluting or bare-metal stent of identical structure in a lesion located in a small coronary artery. Visits were scheduled at discharge, and 30 days, eight months and 24 months after the index procedure. The primary end-point of the study was a 24-month composite of major adverse cardiac and cerebrovascular events, which included death, non-fatal myocardial infarction, ischemia-driven target lesion revascularization, and cerebrovascular accident. The individual components of the primary end-point and the occurrence of stent thrombosis were also prospectively evaluated. The 24-month follow-up was completed by 254 patients (98.8%). The use of sirolimus-eluting stents was associated with a significantly lower incidence of the primary end-point (12.6% versus 33.1%, RR 0.38, 95% CI: 0.21-0.65, P=0.0002), not only due to a reduction in ischemia-driven target lesion revascularization (7.9% versus 29.9%, RR 0.29, 95% CI: 0.14-0.55, P<0.0001), but also to a reduction in myocardial infarction (1.6% versus 10.2%, RR 0.15, 95% CI: 0.0-0.69, P=0.007). Conclusions: In comparison with bare-metal stents, the use of sirolimus-eluting stents in the percutaneous revascularization of small coronary arteries is associated with improved clinical outcomes after two years’ follow-up.