Details

Autor(en) / Beteiligte

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

Titel

Randomized comparative trial of triflusal and aspirin following acute myocardial infarction

Ist Teil von

• European heart journal, 2000-03, Vol.21 (6), p.457-465

Ort / Verlag

Oxford: Oxford University Press

Erscheinungsjahr

2000

Quelle

Oxford Journals 2020 Medicine

Beschreibungen/Notizen

• 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.