title: Retrospective comparison of midterm clinical and angiographic outcomes after the implantation of paclitaxel- and sirolimus-eluting stents for de novo coronary complex lesions in nonrandomized Japanese patients.
abstract: OBJECTIVE
  We retrospectively analyzed the midterm clinical and angiographic outcomes after the implantation of paclitaxel- (PES, TAXUS Express) and sirolimus- (SES, Cypher Bx Velocity) eluting stents in Japanese patients with complex coronary lesions.
  
  
  METHODS
  From August 2004 to May 2009, 1,335 nonrandomized de novo native complex coronary lesions treated with either a PES (357 cases) or SES were included. The inclusion criteria for patients with complex lesions were those with diabetes, those undergoing hemodialysis, and those with a low ejection fraction, as well as subjects who had lesions with severe calcification, ostiums of the right coronary and left circumflex arteries, and who underwent the side-branch bifurcation 2-stent technique. The subjects were evaluated for consistent predictors of cardiac events, binary restenosis and target lesion vascularization of the SES. The composite primary endpoint percentage (900-day cardiac death, nonfatal recurrent myocardial infarction, and definite stent thrombosis) after PES placement was 0.6%, which was not significantly different from that after SES placement (0.12%; p=0.290). The incidence of the secondary endpoint (binary restenosis; stenosis >50% of the diameter at the secondary angiographic examination performed within 550 days after the procedure) after PES placement (15.0%) was also not significantly different than that after SES placement (13.3%; p=0.498). There was no relationship between PES placement and binary restenosis upon angiographic follow-up of 989 lesions (odds ratio of 1.14; 95% confidence interval, 0.73-1.77; p=0.57).
  
  
  CONCLUSIONS
  For de novo native complex coronary stenosis, the midterm safety and efficacy of PES placement was statistically equivalent to that of SES placement in a clinical setting in Japan.
authors.affiliation: Division of Cardiology, Saitama Cardiovascular Respiratory Center, Japan. ishikawa.tetsuya@pref.saitama.lg.jp
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Ishikawa
authors.forename: Yosuke
authors.initials: Y
authors.lastname: Nakano
authors.forename: Makoto
authors.initials: M
authors.lastname: Mutoh
mesh_terms: D000368:Aged; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000209:etiology; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000628:therapy*; D054855:Drug-Eluting Stents / Q000009:adverse effects; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D017239:Paclitaxel / Q000008:administration & dosage*; D012189:Retrospective Studies; D020123:Sirolimus / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D017239:Paclitaxel; D020123:Sirolimus