6/30/23, 12:46 AM WARFASA Pathway Feedback Search Clinical Topics Home Studies WARFASA WARFASA Disease Disease Deep vein thrombosis Pulmonary embolism Trial question What is the effect of aspirin for the prevention of recurrent VTE? Study design Multi-center Double blinded RCT Population Characteristics of study participants 36.0% female N = 403 64.0% male 403 patients (145 female, 257 male) Inclusion criteria: patients with first-ever unprovoked VTE who had completed 6 to 18 months of OAC treatment Key exclusion criteria: cancer, major thrombophilia, an indication for long-term anticoagulant therapy for AF or prosthetic heart valve, active bleeding or high risk for bleeding, allergy or intolerance to aspirin, life expectancy < 6 months Interventions N=205 aspirin (100 mg daily for 2 years) N=197 placebo (matching placebo daily for 2 years) Primary outcome Recurrence of venous thromboembolism 11.2 % 11.2 https://web.pathway.md/studies/rec2yz7ldizptyxub 1/2 6/30/23, 12:46 AM WARFASA Pathway 8.4 % 6.6 5.6 % Significant decrease 2.8 % NNT = 22 0.0 % Aspirin Placebo Significant decrease in recurrence of VTE (6.6% vs. 11.2%; HR 0.58, 95% CI 0.36 to 0.93) Secondary outcomes Significant decrease in recurrence due to PE (6.7% vs. 13.5%; HR 0.38, 95% CI 0.17 to 0.88) No significant difference in recurrence due to deep vein thrombosis (6.5% vs. 10.2%; HR 0.65, 95% CI 0.65 to 1.2) No significant difference in death (1.4% vs. 1.3%; HR 1.04, 95% CI 0.32 to 3.42) Safety outcomes No significant difference in adverse events and major bleeding episode. Conclusion In patients with first-ever unprovoked VTE who had completed 6 to 18 months of OAC treatment, aspirin was superior to placebo with respect to recurrence of VTE. Reference Becattini C, Agnelli G, Schenone A et al. Aspirin for preventing the recurrence of venous thromboembolism. N Engl J Med. 2012 May 24;366(21):1959-67. Open reference URL https://web.pathway.md/studies/rec2yz7ldizptyxub 2/2