title: Clinical outcomes in patients with ST-segment elevation myocardial infarction treated with everolimus-eluting stents versus bare-metal stents (EXAMINATION): 5-year results of a randomised trial.
abstract: BACKGROUND
  Data for the safety and efficacy of new-generation drug-eluting stents at long-term follow-up, and specifically in patients with ST-segment elevation myocardial infarction, are scarce. In the EXAMINATION trial, we compared everolimus-eluting stents (EES) with bare-metal stents (BMS) in an all-comer population with ST-segment elevation myocardial infarction. In this study, we assessed the 5-year outcomes of the population in the EXAMINATION trial.
  
  
  METHODS
  In the multicentre EXAMINATION trial, done in Italy, Spain, and the Netherlands, patients with ST-segment elevation myocardial infarction were randomly assigned in a 1:1 ratio to receive EES or BMS. The random allocation schedule was computer-generated and central randomisation (by telephone) was used to allocate patients in blocks of four or six, stratified by centre. Patients were masked to treatment assignment. At 5 years, we assessed the combined patient-oriented outcome of all-cause death, any myocardial infarction, or any revascularisation. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00828087.
  
  
  RESULTS
  1498 patients were randomly assigned to receive either EES (n=751) or BMS (n=747). At 5 years, complete clinical follow-up data were obtained for 731 patients treated with EES and 727 treated with BMS (97% of both groups). The patient-oriented endpoint occurred in 159 (21%) patients in the EES group versus 192 (26%) in the BMS group (hazard ratio 0·80, 95% CI 0·65-0·98; p=0·033). This difference was mainly driven by a reduced rate of all-cause mortality (65 [9%] vs 88 [12%]; 0·72, 0·52-0·10; p=0·047).
  
  
  CONCLUSIONS
  Our findings should be taken as a point of reference for the assessment of new bioresorbable polymer-based metallic stents or bioresorbable scaffolds in patients with ST-segment elevation myocardial infarction.
  
  
  BACKGROUND
  Spanish Heart Foundation.
authors.affiliation: University Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain. Electronic address: masabate@clinic.ub.es.
authors.forename: Manel
authors.initials: M
authors.lastname: Sabaté
authors.affiliation: University Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Brugaletta
authors.affiliation: University Hospital of Bellvitge, Barcelona, Spain.
authors.forename: Angel
authors.initials: A
authors.lastname: Cequier
authors.affiliation: Hospital do Meixoeiro, Vigo, Spain.
authors.forename: Andrés
authors.initials: A
authors.lastname: Iñiguez
authors.affiliation: University Hospital of Sant Pau, Barcelona, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Serra
authors.affiliation: University Hospital San Carlos, Madrid, Spain.
authors.forename: Pilar
authors.initials: P
authors.lastname: Jiménez-Quevedo
authors.affiliation: Hospital General of Alicante, Alicante, Spain.
authors.forename: Vicente
authors.initials: V
authors.lastname: Mainar
authors.affiliation: University Hospital Ferrara, Ferrara, Italy.
authors.forename: Gianluca
authors.initials: G
authors.lastname: Campo
authors.affiliation: University Hospital Bolognini Seriate, Bergamo, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Tespili
authors.affiliation: Amphia Ziekenhuis, Breda, Netherlands.
authors.forename: Peter
authors.initials: P
authors.lastname: den Heijer
authors.affiliation: Hospital Son Espases, Palma de Mallorca, Spain.
authors.forename: Armando
authors.initials: A
authors.lastname: Bethencourt
authors.affiliation: Hospital Juan Canalejo, A Coruña, Spain.
authors.forename: Nicolás
authors.initials: N
authors.lastname: Vazquez
authors.affiliation: Cardialysis, Rotterdam, Netherlands.
authors.forename: Gerrit Anne
authors.initials: GA
authors.lastname: van Es
authors.affiliation: Cardialysis, Rotterdam, Netherlands.
authors.forename: Bianca
authors.initials: B
authors.lastname: Backx
authors.affiliation: Erasmus MC, Rotterdam, Netherlands; University Hospital of Bern, Inselhospital, Bern, Switzerland.
authors.forename: Marco
authors.initials: M
authors.lastname: Valgimigli
authors.affiliation: International Centre of Circulatory Health, Imperial College London, London, UK.
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
mesh_terms: D000368:Aged; D002423:Cause of Death; D054855:Drug-Eluting Stents; D023381:Endpoint Determination; D005060:Europe / Q000453:epidemiology; D000068338:Everolimus / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008670:Metals; D009203:Myocardial Infarction / Q000453:epidemiology / Q000628:therapy*; D009204:Myocardial Revascularization / Q000706:statistics & numerical data; D063868:Patient Outcome Assessment; D011446:Prospective Studies; D016037:Single-Blind Method; D015607:Stents; D013927:Thrombosis / Q000453:epidemiology
chemical_list: D008670:Metals; D000068338:Everolimus