Triflusal vs. Aspirin for the Prevention of Infarction: a Randomized Stroke Study (TAPIRSS)
Background:TAPIRSS is a randomized, double-blind, multicenter pilot trial designed to study the efficacy of triflusal for the prevention of secondary ischemic stroke conducted in Buenos Aires, Argentina. Triflusal is an antiplatelet agent structurally related to aspirin. Methods and Results:From October 1996 to October 1999 patients were randomized to group #1 (aspirin therapy, 325 mg/daily) or group #2 (triflusal, 600 mg/daily). All patients had experienced either an ischemic stroke (80.9%) or a transient ischemic attack within 6 months prior to randomization. Patients were treated for a median of 586 days. Data for 429 patients were analyzed. Primary endpoints were: cardiovascular death 3.7%(#1)/2.3%(#2)[OR=1.6]; cerebral ischemic infarction 7.4%(#1)/8.0%(#2)[OR=0.92]; non-fatal myocardial infarction 2.3%(#1)/1.9%(#2)[OR=1.24];severe hemorrhage any kind 3.2%(#1)/0.5%(#2)[OR=7.1][p=0.068]. Secondary endpoints were: non-vascular death 2.4%(#1)/0.5%(#2)[OR=5.02]; non-severe hemorrhage 6.0%(#1)/2.3%(#2)[OR=2.66][p=0.058]; systemic thromboembolism 0.9%(#1)/1.4%(#2)[OR=0.65]. Aggregate analysis of primary endpoints showed no significant differences between aspirin and triflusal. Aggregate analysis of secondary enpoints showed a significant difference in favor of triflusal [p=0.038]. Analysis of the combination severe and non-severe hemorrhage showed a significantly reduced incidence of hemorrhagic events with triflusal [8.3%(#1)/2.8%(#2), p=0.013]. Dyspepsia and gastrointestinal discomfort were the most common adverse events in the triflusal group. Conclusions: Triflusal shows a protective effect similar to aspirin in the prevention of secondary ischemic stroke with a lesser risk of hemorrhagic complications. Also, triflusal may be safe for the primary prevention of ischemic stroke.