Incidence of haemorrhagic stroke in fibrinolytic treated patients after acute myocardial infarction. TIM study: A subgroup analysis

Background: Fibrinolytic therapy increases the risk of haemorrhagic stroke in acute myocardial infarction (AMI). The TIM study compared triflusal and aspirin (ASA) efficacy in AMI. Primary endpoint (acumulative incidence of death, non fatal stroke or non fatal reinfarction in first 35 days) showed no differences between treatment groups. Triflusal significantly reduced the incidence of non fatal stroke. Objective: To assess the incidence of stroke in patients receiving fibrinolysis, a subgroup analyses from TIM study has been performed. Methods: 2124 patients with AMI were randomised to receive triflusal (600 mg/d) or AAS (300 mg/d) during 35 days according to a double blind sequential design. Results: Baseline demographic and prognostic characteristics (age, sex, coronary risk factors and previous stroke) were similar in both treatment groups. 747/1056 (70.7%) and 756/1068 (70.8%) patients received fibrinolytic drugs in triflusal and ASA groups respectively. rt-PA was administered to 56.5% and 58.6%, and full dose iv heparin to 75.5% and 72, 1% of these patients. Occurrence of stroke is detailed below: Total Stroke Haemorraghic Stroke Ischaemic Stroke N n % n % N % Triflusal 747 5 0.7 1 0.1 4 0.6 ASA 756 14 1.9 8 1.1 6 0.8 Total 1503 19 1.3 9 0.6 10 0.7 The incidence of haemorraghic stroke in fibrinolysed patients was significantly lower in the triflusal treated group (p = 0.038). Conclusion: Triflusal was associated with a significantly lower rate of haemorrhagic stroke in patients receiving fibrinolytic treatment for AMI.