title: Long-term outcome of sirolimus-eluting vs bare-metal stent in the setting of acute myocardial infarction: 5-year results of the SESAMI trial.
abstract: BACKGROUND
  few long-term randomized data on safety and effectiveness of sirolimus-eluting stent (SES) in the ST-segment elevation myocardial infarction (STEMI) setting are available. The aim of the present investigation was to evaluate the 5-year clinical outcome of SES vs bare-metal stent (BMS) implantation in patients with STEMI.
  
  
  METHODS
  320 STEMI patients were randomized to receive SES or BMS. The primary end-point was the incidence of target vessel failure (TVF) at 5-year follow-up. The secondary end-points were the rate of target lesion revascularization (TLR), major adverse cardiovascular events (MACE), death or non-fatal MI and stent thrombosis (ST). Event rates from 1 to 5 years in patients undergoing TLR and those TLR free at 1 year were also investigated.
  
  
  RESULTS
  The 5-year survival rate free from TVF and TLR was significantly higher in the SES than in the BMS group (85% vs 76% p=0.038; 92% vs 85% p=0.045, respectively). The lower incidence of adverse events was achieved in the first year of follow-up. The cumulative incidence of MACE, death or non-fatal MI and ST was comparable in the 2 groups at 5-year follow-up. Moreover death or MI incidence was 5% in the patients who did not experience TLR within 1-year and 16% in those who experience TLR in the same period (p=0.033). Predictors of death or MI during 5-year follow-up were TLR within 1 year (OR 3.4, 95% CI 1.1-10.1; p=0.04) and small vessels treatment (OR 4.8 95% CI 1.7-13.0; p=0.002).
  
  
  CONCLUSIONS
  The clinical benefits of SES are maintained up to 5years without safety concerns.
authors.affiliation: Interventional Cardiology Unit, San Camillo Hospital, via Circonvallazione Gianicolense n. 87, Rome, Italy. cmusto@hotmail.it
authors.forename: Carmine
authors.initials: C
authors.lastname: Musto
authors.forename: Rosario
authors.initials: R
authors.lastname: Fiorilli
authors.forename: Francesco
authors.initials: F
authors.lastname: De Felice
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Patti
authors.forename: Marco Stefano
authors.initials: MS
authors.lastname: Nazzaro
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Scappaticci
authors.forename: Leda
authors.initials: L
authors.lastname: Bernardi
authors.forename: Roberto
authors.initials: R
authors.lastname: Violini
mesh_terms: D000368:Aged; D054855:Drug-Eluting Stents / Q000639:trends; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008670:Metals / Q000008:administration & dosage*; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality* / Q000601:surgery*; D062645:Percutaneous Coronary Intervention / Q000639:trends; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents / Q000639:trends*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D008670:Metals; D020123:Sirolimus