TY - JOUR
T1 - Comparison of triflusal with aspirin in the secondary prevention of atherothrombotic events; Α randomised clinical trial
AU - Kalantzi, Kallirroi I.
AU - Ntalas, Ioannis V.
AU - Chantzichristos, Vasileios G.
AU - Tsoumani, Maria E.
AU - Adamopoulos, Dimitrios
AU - Asimakopoulos, Christos
AU - Bourdakis, Adamantios
AU - Darmanis, Petros
AU - Dimitriadou, Alexandra
AU - Gkiokas, Stefanos
AU - Ipeirotis, Konstantinos
AU - Kitikidou, Kyriaki
AU - Klonaris, Ioannis
AU - Kostaki, Aglaia
AU - Logothetis, Dimitrios
AU - Mainas, Konstantinos
AU - Mais, Theodoros
AU - Maragiannis, Athanasios
AU - Martiadou, Konstantina
AU - Mavronasos, Konstantinos
AU - Michelongonas, Ioannis
AU - Mitropoulos, Dimitrios
AU - Papadimitriou, Georgios
AU - Papadopoulos, Achilleas
AU - Papaioakeim, Miltiadis
AU - Sofillas, Kosmas
AU - Stabola, Sotiria
AU - Stefanakis, Emmanouil
AU - Stergiou, Dimitrios
AU - Thoma, Maria
AU - Zenetos, Alexandros
AU - Zisekas, Stergios
AU - Goudevenos, John A.
AU - Panagiotakos, Demosthenes B.
AU - Tselepis, Alexandros D.
N1 - Funding Information:
This study was partially supported by a grant from Ga-lenica S.A. (Grant No. 81890).
Publisher Copyright:
© 2019 Bentham Science Publishers.
PY - 2019
Y1 - 2019
N2 - Background: Triflusal has demonstrated an efficacy similar to aspirin in the prevention of vascular events in patients with acute myocardial infarction (ΜΙ) 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. Methods: 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) ΜΙ, (b) stroke (ischaemic or haemorrhagic), or, (c) death from vascular causes for the entire follow-up period. The primary safety endpoints 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 ΜΙ 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).
AB - Background: Triflusal has demonstrated an efficacy similar to aspirin in the prevention of vascular events in patients with acute myocardial infarction (ΜΙ) 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. Methods: 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) ΜΙ, (b) stroke (ischaemic or haemorrhagic), or, (c) death from vascular causes for the entire follow-up period. The primary safety endpoints 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 ΜΙ 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).
KW - Aspirin
KW - Bleeding
KW - Coronary artery disease
KW - Myocardial infarction
KW - Stroke
KW - Triflusal
UR - http://www.scopus.com/inward/record.url?scp=85073050532&partnerID=8YFLogxK
U2 - 10.2174/1570161116666180605090520
DO - 10.2174/1570161116666180605090520
M3 - Article
C2 - 29866011
AN - SCOPUS:85073050532
SN - 1570-1611
VL - 17
SP - 635
EP - 643
JO - Current Vascular Pharmacology
JF - Current Vascular Pharmacology
IS - 6
ER -