Comparison of Triflusal with Aspirin in the Secondary Prevention of Atherothrombotic Events; A Randomised Clinical Trial

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Author(s): Kallirroi I. Kalantzi, Ioannis V. Ntalas, Vasileios G. Chantzichristos, Maria E. Tsoumani, Dimitrios Adamopoulos, Christos Asimakopoulos, Adamantios Bourdakis, Petros Darmanis, Alexandra Dimitriadou, Stefanos Gkiokas, Konstantinos Ipeirotis, Kyriaki Kitikidou, Ioannis Klonaris, Aglaia Kostaki, Dimitrios Logothetis, Konstantinos Mainas, Theodoros Mais, Athanasios Maragiannis, Konstantina Martiadou, Konstantinos Mavronasos, Ioannis Michelongonas, Dimitrios Mitropoulos, Georgios Papadimitriou, Achilleas Papadopoulos, Miltiadis Papaioakeim, Kosmas Sofillas, Sotiria Stabola, Emmanouil Stefanakis, Dimitrios Stergiou, Maria Thoma, Alexandros Zenetos, Stergios Zisekas, John A. Goudevenos, Demosthenes B. Panagiotakos, Alexandros D. Tselepis*.

Journal Name: Current Vascular Pharmacology

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Abstract:

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 bleeding events.

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).

Keywords: Aspirin, bleeding, coronary artery disease, myocardial infarction, stroke, triflusal.

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(E-pub Ahead of Print)
DOI: 10.2174/1570161116666180605090520
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