title: Direct stenting of native de novo coronary artery lesions with the sirolimus-eluting stent: a post hoc subanalysis of the pooled E- and C-SIRIUS trials.
abstract: OBJECTIVE
  We sought to assess the impact of direct stenting (DS) using the sirolimus-eluting stent (SES) on angiographic and clinical outcomes.
  
  
  BACKGROUND
  The SES is superior to bare-metal stents in the treatment of native de novo coronary artery lesions in randomized, controlled trials.
  
  
  METHODS
  A post hoc analysis was performed on 225 patients (158 men; 62 +/- 11 years old) who received SES in the pooled cohorts of the European and Canadian Sirolimus-Eluting Stent in Coronary Lesions (E-SIRIUS and C-SIRIUS, respectively) trials. Of these patients, 57 (25%) had undergone DS at the investigator's discretion. Lesion predilation preceded SES implantation in the remaining 168 patients.
  
  
  RESULTS
  Patient and lesion characteristics were no different between the two subgroups, except for a lower prevalence of moderate to severe lesion calcification (5% vs. predilation 19%, p=0.017) and a lower baseline diameter stenosis (61.6% vs. predilation 68.1%, p <0.001) in the DS subgroup. At eight months, in-lesion late loss (0.10 vs. 0.19 mm at predilation, p=0.14) and in-lesion binary restenosis (2.0% vs. 6.1% at predilation, p=0.46) tended to be lower after DS. Clinical follow-up at one year revealed non-significantly reduced incidences of target lesion revascularization (1.8% vs. 5.4% at predilation, p=0.46) and major adverse cardiac events (5.3% vs. 8.9% at predilation, p=0.57).
  
  
  CONCLUSIONS
  Direct SES deployment performed at the investigator's discretion was as safe and efficacious at mid-term follow-up as stenting preceded by lesion predilation.
authors.affiliation: Center for Cardiology and Vascular Intervention, Hamburg, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Schlüter
authors.forename: Joachim
authors.initials: J
authors.lastname: Schofer
authors.forename: Anthony H
authors.initials: AH
authors.lastname: Gershlick
authors.forename: Erick
authors.initials: E
authors.lastname: Schampaert
authors.forename: William
authors.initials: W
authors.lastname: Wijns
authors.forename: Günter
authors.initials: G
authors.lastname: Breithardt
mesh_terms: D000368:Aged; D002986:Clinical Trials as Topic; D017023:Coronary Angiography; D003327:Coronary Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D011474:Prosthesis Design; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents
chemical_list: D007166:Immunosuppressive Agents; D020123:Sirolimus