title: 5-year clinical outcomes after sirolimus-eluting stent implantation insights from a patient-level pooled analysis of 4 randomized trials comparing sirolimus-eluting stents with bare-metal stents.
abstract: OBJECTIVE
  Five-year clinical follow-up has been scheduled per protocol by the 4 Cypher (Cordis/Johnson & Johnson, Warren, New Jersey) sirolimus-eluting stent (SES) versus bare-metal stent (BMS) randomized trials.
  
  
  BACKGROUND
  A delayed arterial healing response after drug-eluting stent implantation has raised concerns about the long-term safety of drug-eluting stents.
  
  
  METHODS
  In a pooled analysis of 4 randomized trials, 1,748 patients were assigned to receive either an SES (n = 878) or BMS (n = 870).
  
  
  RESULTS
  At 5 years, there was no significant difference in the rate of death, myocardial infarction (MI), or the composite of death/MI between the 2 groups (15.1% in the SES group vs. 13.6% in the BMS group; p = 0.36). The 5-year incidence of stent thrombosis by the Academic Research Consortium definition did not differ between SES and BMS (definite/probable stent thrombosis, 2.1% vs. 2.0%; p = 0.99). The incidence of very late stent thrombosis was also similar between the SES and BMS groups (1.4% vs. 0.7%; p = 0.22). The annualized rates of definite/probable stent thrombosis after 1 year were 0.4% for SES and 0.2% for BMS. The 5-year incidence of target vessel revascularization was significantly lower in the SES group (15.2% vs. 30.1%; p < 0.0001).
  
  
  CONCLUSIONS
  In this patient-level pooled analysis, overall use of SES compared with BMS demonstrated persistent superior efficacy at 5 years in terms of a reduction in target vessel revascularization, without an increase in rates of death, MI, or stent thrombosis. (The Initial Double-Blind Drug-Eluting Stent vs Bare-Metal Stent Study, NCT00233805; The Study of the BX Velocity Stent in the Treatment of De Novo Artery Lesions, NCT00381420; Study of Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in Treatment of de Novo Native Coronary Artery Lesions [SIRIUS], NCT00232765; The Study of the BX VELOCITY Stent In Patients With De Novo Coronary Artery Lesions, NCT00235144).
authors.affiliation: Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York, USA.
authors.forename: Adriano
authors.initials: A
authors.lastname: Caixeta
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.forename: Alexandra J
authors.initials: AJ
authors.lastname: Lansky
authors.forename: Eugenia
authors.initials: E
authors.lastname: Nikolsky
authors.forename: Jiro
authors.initials: J
authors.lastname: Aoki
authors.forename: Jeffrey W
authors.initials: JW
authors.lastname: Moses
authors.forename: Joachim
authors.initials: J
authors.lastname: Schofer
authors.forename: Marie-Claude
authors.initials: MC
authors.lastname: Morice
authors.forename: Erick
authors.initials: E
authors.lastname: Schampaert
authors.forename: Ajay J
authors.initials: AJ
authors.lastname: Kirtane
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Popma
authors.forename: Helen
authors.initials: H
authors.lastname: Parise
authors.forename: Martin
authors.initials: M
authors.lastname: Fahy
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
mesh_terms: D000368:Aged; D003327:Coronary Disease / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000517:prevention & control; D054855:Drug-Eluting Stents / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008670:Metals; D015337:Multicenter Studies as Topic; D009203:Myocardial Infarction / Q000401:mortality; D009204:Myocardial Revascularization; D016032:Randomized Controlled Trials as Topic; D020123:Sirolimus; D015607:Stents; D013927:Thrombosis / Q000209:etiology; D016896:Treatment Outcome
chemical_list: D008670:Metals; D020123:Sirolimus