Objective: To evaluate the mid-term outcomes of sirolimus-eluting stents (SES; Cypher Bx Velocity) for de novo coronary stenosis in a Japanese clinical setting, and to compare these with the outcomes using bare-metal stents (BMS).
Methods: This study was a nonrandomized, lesion-based, and single-center study, retrospectively investigated in October 2010. We enrolled 2031 consecutive cases with de novo coronary lesions treated with BMS (n=587) or SES (n=1,444) from January 2003 to May 2007. SES use ratio during the available interval was 95.5%. The primary endpoint was the incidence of target vessel failure (TVF: comprising cardiac death, nonfatal recurrent MI, definite stent thrombosis (ST), and severe restenosis [% diameter stenosis (%DS) at secondary angiography ≥70%]. The secondary endpoint was the incidence of binary in-stent restenosis (%DS >50%).
Results: The TVF ratio after SES placement (6.6%) was significantly lower than that after BMS placement (11.8%, p<0.001), despite many disadvantageous variables in the SES group. SES related to the risk of TVF (mean follow-up for SES, 1,411 ± 539 days; BMS, 1,818 ± 825 days) (hazard ratio of 0.428 at 95% CI, 0.292-0.627, p<0.001). The ratio of binary in-stent restenosis after SES placement (13.4%) was significantly lower than that after BMS placement (25.1%; p<0.001). SES was significantly related to binary in-stent restenosis (odds ratio of 0.267 at 95% CI, 0.195-0.366, p<0.001).
Conclusion: SES has a more favorable mid-term clinical and angiographic outcome than BMS for de novo coronary stenosis in clinical settings in Japan.