title: Long-term comparison of sirolimus-eluting and bare-metal stents in ST-segment elevation myocardial infarction.
abstract: OBJECTIVE
  We aimed to investigate, in patients with ST-segment elevation myocardial infarction (STEMI), whether the previously reported clinical benefits of sirolimus-eluting stent(s) (SES) in terms of reducing a major adverse cardiac and cerebrovascular event (MACCE) compared with bare-metal stent(s) (BMS) were maintained over a 5-year time period.
  
  
  BACKGROUND
  In the prospective single-centre randomized DEBATER trial, SES significantly reduced the rate of MACCE in STEMI patients within 1 year compared with BMS, mainly driven by a reduction of target lesion revascularization. Randomized data on the long-term safety and efficacy of SES in STEMI patients are conflicting and limited.
  
  
  METHODS
  Between January 2006 and May 2008, a total of 907 STEMI patients were randomized to receive SES or BMS. The primary endpoint was MACCE defined as the composite of death, myocardial infarction, stroke, repeat revascularization and bleeding. Five-year follow-up data were collected by reviewing hospital records, telephone calls and a written questionnaire.
  
  
  RESULTS
  At 5 years, the rate of MACCE between the SES group and the BMS group was no longer significantly different (33.3 vs. 39.3%, P=0.12). The cumulative incidence of death and myocardial infarction was similar in both groups (11.0 vs. 9.7%, P=0.51). Repeat revascularization was performed in 21.1 and 25.8% of patients, respectively (P=0.12). The rate of very late stent thrombosis (1-5 years of follow-up) was very low in both groups (2.0 vs. 0.7%, P=0.12).
  
  
  CONCLUSIONS
  The benefits of SES in STEMI patients in terms of reducing MACCE faded over time. We found no safety concerns in terms of SES in the long term, with extremely low rates of very late stent thrombosis.
authors.affiliation: aDepartment of Cardiology, Catharina Hospital Eindhoven bDepartment of Biomedical Engineering, Eindhoven University of Technology, Eindhoven cAcademic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
authors.forename: Inge
authors.initials: I
authors.lastname: Wijnbergen
authors.forename: Jan
authors.initials: J
authors.lastname: Tijssen
authors.forename: Guus
authors.initials: G
authors.lastname: Brueren
authors.forename: Kathinka
authors.initials: K
authors.lastname: Peels
authors.forename: Jan Melle
authors.initials: JM
authors.lastname: van Dantzig
authors.forename: Marcel Van't
authors.initials: MV
authors.lastname: Veer
authors.forename: Jacques J
authors.initials: JJ
authors.lastname: Koolen
authors.forename: Rolf
authors.initials: R
authors.lastname: Michels
authors.forename: Nico H J
authors.initials: NH
authors.lastname: Pijls
mesh_terms: D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003328:Coronary Thrombosis / Q000209:etiology / Q000401:mortality / Q000628:therapy; D054855:Drug-Eluting Stents; D006801:Humans; D053208:Kaplan-Meier Estimate; D008670:Metals; D009203:Myocardial Infarction / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D009426:Netherlands; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011446:Prospective Studies; D011474:Prosthesis Design; D012008:Recurrence; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D008670:Metals; D020123:Sirolimus