title: Long-term outcome after sirolimus-eluting stents versus bare metal stents in patients with diabetes mellitus: a patient-level meta-analysis of randomized trials.
abstract: BACKGROUND
  Although it is widely believed that patients with diabetes mellitus obtain the greatest benefit from drug-eluting stents, convincing evidence on long-term efficacy and safety of these stents is lacking.
  
  
  METHODS
  We performed a meta-analysis of individual patient data from four randomized trials including 583 patients comparing sirolimus eluting with bare metal stents (median follow-up of 4.2 years). These were the only specific trials reporting on drug-eluting stents in diabetic patients. The primary endpoint was the incidence of major cardiac events. The secondary endpoints were all-cause mortality and myocardial infarction as a safety endpoint and target lesion re-intervention as an efficacy endpoint. Stent thrombosis was also evaluated.
  
  
  RESULTS
  There was a significant reduction in the overall hazard of major cardiac events (hazard ratio [HR] 0.48, 95% confidence interval [CI] 0.36-0.63, P < 0.001) with sirolimus-eluting stents. This was mostly due to a significant reduction in the overall hazard of repeat revascularization (HR 0.27, 95% CI 0.18-0.41, P < 0.001) in favor of sirolimus-eluting stents. However, the overall hazard of death (HR 0.91, 95% CI 0.59-1.41, P = 0.68) as well as death or myocardial infarction (HR 0.77, 95% CI 0.54-1.09, P = 0.14) were not significantly different between the groups. No significant differences were observed regarding stent thrombosis (HR 0.50, 95% CI 0.15-1.69, P = 0.26).
  
  
  CONCLUSIONS
  Sirolimus-eluting stents are highly effective in reducing the risk for major cardiac events and safe in diabetic patients with coronary artery disease.
authors.affiliation: Deutsches Herzzentrum, Technische Universität, Lazarettstr. 36, 80636, Munich, Germany.
authors.forename: Antoinette
authors.initials: A
authors.lastname: de Waha
authors.forename: Alban
authors.initials: A
authors.lastname: Dibra
authors.forename: Sebastian
authors.initials: S
authors.lastname: Kufner
authors.forename: Dietrich
authors.initials: D
authors.lastname: Baumgart
authors.forename: Manel
authors.initials: M
authors.lastname: Sabate
authors.forename: Aleardo
authors.initials: A
authors.lastname: Maresta
authors.forename: Albert
authors.initials: A
authors.lastname: Schömig
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
mesh_terms: D000368:Aged; D003324:Coronary Artery Disease / Q000150:complications / Q000401:mortality / Q000628:therapy*; D048909:Diabetes Complications; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D020123:Sirolimus; D015607:Stents / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D020123:Sirolimus