Copyright © 2000 by the European Society of Cardiology.
Randomized comparative trial of triflusal and aspirin following acute myocardial infarction
a Department of Cardiology, Hospital Universitario Virgen de la Macarena, Sevilla, Spain
b Department of Cardiology, Hospital Universitario de Getafe, Madrid, Spain
c Department of Cardiology, Hospital Vall D'Hebron, Barcelona, Spain
d Department of Cardiology, Hospital La Fe, Valencia, Spain
e Department of Cardiology, Hospital La Paz, Madrid, Spain
f Department of Cardiology, Hospital General, Valencia, Spain
g Department of Cardiology, Hospital Juan Canalejo, La Coruña, Spain
h Laboratorio de Bioestadística y Epidemiología, Facultad de Medicina, UAB, Barcelona, Spain
i Department of Cardiology, Hospital Torrecárdenas, Almería, Spain
j Department of Cardiology, Hospital Miguel Servet, Zaragoza, Spain
revised July 5, 1999; accepted July 21, 1999
Abstract
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 24h of acute myocardial infarction symptom onset to receive triflusal 600mg or aspirin 300mg 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.
Key Words: Triflusal, aspirin, cardiovascular events, cerebrovascular events, acute myocardial infarction, sequential trial
f1 Correspondence: Professor J. M. Cruz-Fernández, Servicio de Cardiología, Hospital Universitario Virgen de la Macarena, Avda Dr. Fedriani, s/n, 41009 Sevilla, Spain.
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