Randomized comparative trial of triflusal and aspirin following acute myocardial infarction

J. M. Cruz-Fernández, L. López-Bescós, D. García-Dorado, V. López García-Aranda, A. Cabadés, L. Martín-Jadraque, J. A. Velasco, A. Castro-Beiras, F. Torres, F. Marfil, E. Navarro

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Aims. To compare the efficacy and tolerability of the antiplatelet agent triflusal with aspirin in the prevention of cardiovascular events following acute myocardial infarction. Methods and 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). Conclusion. 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. (C) 2000 The European Society of Cardiology.
Original languageEnglish
Pages (from-to)457-465
JournalEuropean Heart Journal
Publication statusPublished - 15 Mar 2000


  • Acute myocardial infarction
  • Aspirin
  • Cardiovascular events
  • Cerebrovascular events
  • Sequential trial
  • Triflusal


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