6/28/23, 12:49 AM AVERROES Pathway Feedback Search Clinical Topics Home Studies AVERROES AVERROES Disease Disease Disease Acute ischemic stroke Atrial fibrillation Transient Trial question What is the role of apixaban in patients with AF who are at an increased risk for stroke for whom vitamin K antagonist therapy is unsuitable? Study design Multi-center Double blinded RCT Population Characteristics of study participants 41.0% female N = 5599 59.0% male 5599 patients (2322 female, 3277 male) Inclusion criteria: patients with AF who were at increased risk for stroke and for whom vitamin K antagonist therapy was unsuitable Key exclusion criteria: valvular disease requiring surgery, a serious bleeding event in the previous 6 months or a high risk of bleeding, current alcohol or drug abuse or psychosocial issues, life expectancy < 1 year, or severe renal insufficiency Interventions N=2808 apixaban (5 mg PO BID) N=2791 aspirin (81-324 mg PO once daily) https://web.pathway.md/studies/recwpHaKUTiCV5d8k 1/2 6/28/23, 12:49 AM AVERROES Pathway Primary outcome Incidence of stroke or systemic embolism 3.7 % / y 3.7 2.8 % / y 1.9 % / y 1.6 0.9 % / y Significant decrease 0.0 % / y Apixaban Aspirin Significant decrease in the incidence of stroke or systemic embolism (1.6% / y vs. 3.7% / y; HR 0.45, 95% CI 0.32 to 0.62) Secondary outcomes No significant difference in death (3.5% vs. 4.4%; HR 0.79, 95% CI 0.62 to 1.02) Significant decrease in hospitalization for cardiovascular causes (12.6% vs. 15.9%; HR 0.79, 95% CI 0.69 to 0.91) Safety outcomes No significant differences in major bleeding (1.4% vs. 1.2%, p=0.57; HR 1.13, 95% CI 0.74-1.75). Significant differences in serious adverse event (22% vs. 27%, p < 0.001). Conclusion In patients with AF who were at increased risk for stroke and for whom vitamin K antagonist therapy was unsuitable, apixaban was superior to aspirin with respect to the incidence of stroke or systemic embolism. Reference Connolly SJ, Eikelboom J, Joyner C et al. Apixaban in patients with atrial fibrillation. N Engl J Med. 2011 Mar 3;364(9):806-17. Open reference URL https://web.pathway.md/studies/recwpHaKUTiCV5d8k 2/2