title: Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents.
abstract: BACKGROUND
  The long-term effects of treatment with sirolimus-eluting stents, as compared with bare-metal stents, have not been established.
  
  
  METHODS
  We performed an analysis of individual data on 4958 patients enrolled in 14 randomized trials comparing sirolimus-eluting stents with bare-metal stents (mean follow-up interval, 12.1 to 58.9 months). The primary end point was death from any cause. Other outcomes were stent thrombosis, the composite end point of death or myocardial infarction, and the composite of death, myocardial infarction, or reintervention.
  
  
  RESULTS
  The overall risk of death (hazard ratio, 1.03; 95% confidence interval [CI], 0.80 to 1.30) and the combined risk of death or myocardial infarction (hazard ratio, 0.97; 95% CI, 0.81 to 1.16) were not significantly different for patients receiving sirolimus-eluting stents versus bare-metal stents. There was a significant reduction in the combined risk of death, myocardial infarction, or reintervention (hazard ratio, 0.43; 95% CI, 0.34 to 0.54) associated with the use of sirolimus-eluting stents. There was no significant difference in the overall risk of stent thrombosis with sirolimus-eluting stents versus bare-metal stents (hazard ratio, 1.09; 95% CI, 0.64 to 1.86). However, there was evidence of a slight increase in the risk of stent thrombosis associated with sirolimus-eluting stents after the first year.
  
  
  CONCLUSIONS
  The use of sirolimus-eluting stents does not have a significant effect on overall long-term survival and survival free of myocardial infarction, as compared with bare-metal stents. There is a sustained reduction in the need for reintervention after the use of sirolimus-eluting stents. The risk of stent thrombosis is at least as great as that seen with bare-metal stents.
authors.affiliation: Deutsches Herzzentrum, Technische Universität, Munich, Germany. kastrati@dhm.mhn.de
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
authors.forename: Julinda
authors.initials: J
authors.lastname: Mehilli
authors.forename: Jürgen
authors.initials: J
authors.lastname: Pache
authors.forename: Christoph
authors.initials: C
authors.lastname: Kaiser
authors.forename: Marco
authors.initials: M
authors.lastname: Valgimigli
authors.forename: Henning
authors.initials: H
authors.lastname: Kelbaek
authors.forename: Maurizio
authors.initials: M
authors.lastname: Menichelli
authors.forename: Manel
authors.initials: M
authors.lastname: Sabaté
authors.forename: Maarten J
authors.initials: MJ
authors.lastname: Suttorp
authors.forename: Dietrich
authors.initials: D
authors.lastname: Baumgart
authors.forename: Melchior
authors.initials: M
authors.lastname: Seyfarth
authors.forename: Matthias E
authors.initials: ME
authors.lastname: Pfisterer
authors.forename: Albert
authors.initials: A
authors.lastname: Schömig
mesh_terms: D015906:Angioplasty, Balloon, Coronary; D003327:Coronary Disease / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000453:epidemiology / Q000628:therapy; D003328:Coronary Thrombosis / Q000453:epidemiology / Q000209:etiology*; D016503:Drug Delivery Systems; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D009203:Myocardial Infarction / Q000453:epidemiology / Q000209:etiology; D011474:Prosthesis Design; D011475:Prosthesis Failure; D016032:Randomized Controlled Trials as Topic; D012044:Regression Analysis; D012306:Risk; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents / Q000009:adverse effects*; D016019:Survival Analysis
chemical_list: D007166:Immunosuppressive Agents; D020123:Sirolimus