6/28/23, 12:44 AM ARISTOTLE Pathway Feedback Search Clinical Topics Home Studies ARISTOTLE ARISTOTLE Disease Disease Disease Acute ischemic stroke Atrial fibrillation Transient Trial question What is the role of apixaban in patients with AF? Study design Multi-center Double blinded RCT Population Characteristics of study participants 35.0% female N = 18201 65.0% male 18201 patients (6416 female, 11785 male) Inclusion criteria: patients with AF and at least one additional risk factor for stroke Key exclusion criteria: AF due to a reversible cause, moderate or severe mitral stenosis, conditions other than AF that required anticoagulation (e.g., a prosthetic heart valve), stroke within the previous 7 days, need for aspirin at a dose of > 165 mg a day or for both aspirin and clopidogrel, and severe renal insufficiency Interventions N=9120 apixaban (5 mg PO BID) N=9081 warfarin (dose-adjusted, with target INR 2.0 to 3.0) Primary outcome https://web.pathway.md/studies/recIQaJuFFnfVC1ki 1/2 6/28/23, 12:44 AM ARISTOTLE Pathway Incidence of ischemic or hemorrhagic stroke or systemic embolism 1.6 % / y 1.6 1.2 % / y 1.2 0.8 % / y 0.4 % / y Significant decrease 0.0 % / y Apixaban Warfarin Significant decrease in the incidence of ischemic or hemorrhagic stroke or systemic embolism (1.2% / y vs. 1.6% / y; HR 0.79, 95% CI 0.66 to 0.95) Secondary outcomes Significant decrease in the incidence of major bleeding (2.13% / y vs. 3.09% / y; HR 0.69, 95% CI 0.6 to 0.8) Significant decrease in death from any cause (3.52% vs. 3.94%; HR 0.89, 95% CI 0.8 to 0.99) Significant decrease in the incidence of hemorrhagic stroke (0.24% / y vs. 0.47% / y; HR 0.51, 95% CI 0.35 to 0.75) Safety outcomes No significant difference in adverse events (81.5% vs. 83.1%) and serious adverse events (35.0% vs. 36.5%). Conclusion In patients with AF and at least one additional risk factor for stroke, apixaban was superior to warfarin with respect to the incidence of ischemic or hemorrhagic stroke or systemic embolism. Reference Granger CB, Alexander JH, McMurray JJ et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011 Sep 15;365(11):981-92. Open reference URL https://web.pathway.md/studies/recIQaJuFFnfVC1ki 2/2