title: Randomized comparative trial of triflusal and aspirin following acute myocardial infarction.
abstract: OBJECTIVE
  To compare the efficacy and tolerability of the antiplatelet agent triflusal with aspirin in the prevention of cardiovascular events following acute myocardial infarction.
  
  
  RESULTS
  In this double-blind, multicentre, sequential design study, patients were randomized within 24 h of acute myocardial infarction symptom onset to receive triflusal 600 mg or aspirin 300 mg once daily for 35 days. The primary end-point was death, non-fatal myocardial reinfarction or a non-fatal cerebrovascular event. The incidences of these individual outcomes and urgent revascularization were secondary end-points. The null hypothesis of no difference between treatments in the primary combined end-point was accepted with 80% power after recruiting 2124 validated patients (odds ratio (OR) for failure [95% confidence interval (CI)]: 0.882 [0.634-1.227]). Non-fatal cerebrovascular events were significantly less frequent with triflusal (OR [95% CI]: 0.364 [0.146-0.908]; P = 0.030). There was no significant difference between treatments for death (OR [95% CI]: 0.816 [0.564-1.179]; P = 0.278), non-fatal reinfarction (OR [95% CI]: 1.577 [0.873-2.848]; P = 0.131) or revascularization (OR [95% CI]: 0.864 [0.644-1.161]; P = 0.334). Overall, both drugs were well tolerated, although there was a trend towards fewer bleeding episodes with triflusal; significantly fewer central nervous system bleeding episodes were observed in triflusal-treated patients (0.27% vs. 0.97%; P = 0.033).
  
  
  CONCLUSIONS
  Triflusal and aspirin have similar efficacy in preventing further cardiovascular events after acute myocardial infarction, but triflusal showed a more favourable safety profile. Triflusal significantly reduced the incidence of non-fatal cerebrovascular events compared with aspirin.
authors.affiliation: Department of Cardiology, Hospital Universitario Virgen de la Macarena, Sevilla, Spain.
authors.forename: J M
authors.initials: JM
authors.lastname: Cruz-Fernández
authors.forename: L
authors.initials: L
authors.lastname: López-Bescós
authors.forename: D
authors.initials: D
authors.lastname: García-Dorado
authors.forename: V
authors.initials: V
authors.lastname: López García-Aranda
authors.forename: A
authors.initials: A
authors.lastname: Cabadés
authors.forename: L
authors.initials: L
authors.lastname: Martín-Jadraque
authors.forename: J A
authors.initials: JA
authors.lastname: Velasco
authors.forename: A
authors.initials: A
authors.lastname: Castro-Beiras
authors.forename: F
authors.initials: F
authors.lastname: Torres
authors.forename: F
authors.initials: F
authors.lastname: Marfil
authors.forename: E
authors.initials: E
authors.lastname: Navarro
mesh_terms: D000368:Aged; D001241:Aspirin / Q000009:adverse effects / Q000627:therapeutic use*; D002561:Cerebrovascular Disorders / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000150:complications / Q000188:drug therapy* / Q000517:prevention & control; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D012008:Recurrence; D012459:Salicylates / Q000009:adverse effects / Q000627:therapeutic use*; D013030:Spain; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors; D012459:Salicylates; C016167:triflusal; D001241:Aspirin