Five-year follow-up of the sirolimus-eluting stents vs vascular brachytherapy for bare metal in-stent restenosis (SISR) trial

Objectives: The aim of this study was to evaluate the 5-year clinical safety and efficacy outcomes of patients treated for in-stent restenosis of bare-metal stents (BMSs). Background: The SISR trial is a prospective, randomized trial that compared the safety and efficacy of sirolimus-eluting stent (SES) vs vascular brachytherapy (VBT) for the treatment of BMS in-stent restenosis. Methods: A total of 384 patients with BMS in-stent restenosis were randomized to treatment with SES (n = 259) or VBT (n = 125) and were followed for 5 years. Results: At 5 years, the rates of target lesion revascularization (TLR) had narrowed and were nonsignificant between the SES and VBT groups, with TLR rates of 24.7% and 31.2% (95% CI -16.3% to 2.8%, P =.179) respectively. Target vessel failure was 33.6% vs 36.8% (95% CI -13.5% to 6.7% P =.568) for SES compared with VBT. The rate of major adverse cardiac event at 5 years was 34.0% vs 36.8% (95% CI -13.1% to7.1%, P =.648) for the SES compared with VBT. There were no differences between SES and VBT in terms of survival free from TLR (72.9% vs 66.4%, log-rank P =.08) or from target vessel failure (64.4% vs 61.3%, log-rank P =.349). There were no significant differences in the rates of definite/probable stent thrombosis (5.9% vs 2.5%, 95% CI -7.9% to 1.3%, P =.182) between the 2 groups. Conclusions: At a 5-year follow-up, no differences in safety or efficacy outcomes were observed for treatment of BMS restenosis with SES vs VBT. There were no significant differences in survival free from TLR, target vessel revascularization, or major adverse cardiac events between the 2 groups at 5 years. Sirolimus-eluting stent is a viable treatment option compared with VBT for BMS restenosis.