title: Retrospective comparison of the clinical and angiographic outcomes of the sirolimus-eluting stent and the bare-metal stent in 2031 nonrandomized consecutive de novo native coronary lesions.
abstract: 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).
  
  
  CONCLUSIONS
  SES has a more favorable mid-term clinical and angiographic outcome than BMS for de novo coronary stenosis in clinical settings in Japan.
authors: Department of Cardiology, Saitama Prefecture, Cardiovascular and Respiratory Center, Japan.
authors: Takeyuki
authors: T
authors: Kubota
authors: Tetsuya
authors: T
authors: Ishikawa
authors: Makoto
authors: M
authors: Mutoh
mesh_terms: D000368:Aged; D017023:Coronary Angiography / Q000639:trends*; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging* / Q000453:epidemiology / Q000601:surgery*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents; D016896:Treatment Outcome
chemical_list: D020123:Sirolimus