Background: Triflusal has demonstrated an efficacy similar to aspirin in the prevention of
vascular events in patients with acute myocardial infarction (MI) and ischaemic stroke but with less
Objective: We performed a randomised, multicentre, phase 4 clinical trial to compare the clinical efficacy
and safety of triflusal versus aspirin, administered for 12 months in patients eligible to receive a
cyclooxygenase-1 (COX-1) inhibitor.
Method: Patients with stable coronary artery disease or with a history of non-cardioembolic ischaemic
stroke were randomly assigned to receive either triflusal 300 mg twice or 600 mg once daily or aspirin
100 mg once daily for 12 months. The primary efficacy endpoint was the composite of: (a) MI, (b)
stroke (ischemic or hemorrhagic), or, (c) death from vascular causes for the entire follow-up period. The
primary safety end points were the rate of bleeding events as defined by Bleeding Academic Research
Consortium (BARC) criteria.
Results: At 12-month follow-up, an equivalent result was revealed between the triflusal (n=559) and
aspirin (n=560) in primary efficacy endpoint. Specifically, the combined efficacy outcome rate (i.e. MI,
stroke or death from vascular causes) difference was equal to -1.3% (95% confidence interval -1.1 to
3.5) and lied within the a-priori defined equivalence interval (p<0.001). Regarding the primary safety
endpoints, patients on triflusal treatment were 50% less likely to develop bleeding events according to
the BARC criteria, and especially any clinically overt sign of haemorrhage that requires diagnostic studies,
hospitalisation or special treatment (BARC type 2).
Conclusion: The efficacy of triflusal in the secondary prevention of vascular events is similar to aspirin
when administered for 12 months. Importantly, triflusal significantly reduced the incidence of MI and
showed a better safety profile compared with aspirin.
(ASpirin versus Triflusal for Event Reduction In Atherothrombosis Secondary prevention, ASTERIAS
trial; Clinical Trials.gov Identifier: NCT02616497).