Triflusal vs aspirin in the acute phase of myocardial infarction: The TIM study main results

Background: There is firm evidence that treatment with aspirin (ASA) improves the prognosis of patients with acute myocardial infarction (MI) receiving or not thrombolytic therapy. Triflusal is a new irreversible platelet cyclooxygenase inhibitor with negligible effect on PGI2 synthesis. Objective: To compare the effectiveness of triflusal and ASA in patients with acute MI. Methods: 2124 patients less than 80 years old with acute MI who had not received ASA or any other antiplatelet drug during the previous 15 days were randomly assigned to receive either 600 mg of triflusal (n = 1056) or 300 mg of ASA (n = 1068) every 24 hours according to a double-blind, sequential, truncated design. The primary end-point was the cumulative event rate for death, non fatal re-infarction or non fatal cerebrovascular event (CV) during the first 35 days of evolution. Each of these three events separately and revascularization procedures were secondary end-points. Results: Baseline characteristics including age (61 ± 12 years), sex (82% males), frequency of risk factors (smoking 55%, hypercholesterolemia 38%, diabetes 22%, hypertension 38%) and previous history of ischaemic heart disease (40%) or stroke (3%) were similar in both groups. No differences were observed in treatment received during the index event including fibrinolytic drugs in 71% of patients and full-dose heparin in 67%. Main results were: Triflusal ASA N = 1056 N = 1068 OR (95% CI) N (%) * Death, non fatal MI or CV 99 (9.1) 105 (10.2) 0.88 (0.63 - 1.23) Death 69 (6.3) 79 (7.6) 0.82 (0.56 - 1.18) Non fatal MI 30 (2.8) 18 (1.8) 1.58 (0.87 - 2.85) Non fatal CV 5 (0.5) 14 (1.3) 0.36 (0.15 - 0.91) Revascularization 91 (8.6) 105 (9.8) 0.86 (0.64 - 1.16) • percentages adjusted by sequential analysis Globally adverse events incidence was similar in both groups, although a trend towards less haemorrhagic events (24 versus 38, p = 0.09) and significantly less central nervous system haemorrages (3 versus 11, p = 0.03) were observed in the triflusal group. Conclusion: In acute MI, triflusal was as effective as ASA in the prevention of cumulative rate of death, non fatal re-infarction or non fatal cerebrovascular events. In addition, triflusal significantly reduced the incidence of non fatal cerebrovascular events. Central nervous system haemorrages were significantly less frequent with triflusal.