6/28/23, 11:44 PM ORBIT-AF Pathway Feedback Search Clinical Topics Home Studies ORBIT AF ORBIT AF Disease Disease Disease Acute ischemic stroke Atrial fibrillation Transient Trial question What is the role of concomitant aspirin therapy in patients with AF receiving oral anticoagulation? Study design Multi-center Open label Observational study Population Characteristics of study participants 43.0% female N = 7347 57.0% male 7347 patients (3159 female, 4188 male) Inclusion criteria: patients with AF receiving oral anticoagulation Key exclusion criteria: anticipated life expectancy < 6 months, transient AF secondary to a reversible condition, such as, hyperthyroidism, PE, or postcardiothoracic surgery Interventions N=2543 dual therapy (aspirin plus oral anticoagulation therapy) N=4804 single therapy (oral anticoagulation alone) Primary outcome All-cause hospitalization 23.0 % 23 https://web.pathway.md/studies/recQR5QeanONeTRHr 1/2 6/28/23, 11:44 PM ORBIT-AF Pathway 3 19 17.3 % 11.5 % 5.8 % Borderline significant increase 0.0 % Dual therapy Single therapy Borderline significant increase in all-cause hospitalization (23% vs. 19%; aHR 1.08, 95% CI 1.08 to 1.17) Secondary outcomes No significant difference in nuisance bleeding (11% vs. 10%; aOR 1.09, 95% CI 0.96 to 1.25) Safety outcomes No significant differences in rates of ischemic events including myocardial infarction, coronary revascularization, stroke or non-CNS embolism, and TIA. Significant difference in intracranial hemorrhage (0.43% vs. 0.14%). Conclusion In patients with AF receiving oral anticoagulation, dual therapy was superior to single therapy with respect to a all-cause hospitalization. Reference Steinberg BA, Kim S, Piccini JP et al. Use and associated risks of concomitant aspirin therapy with oral anticoagulation in patients with atrial fibrillation: insights from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) Registry. Circulation. 2013 Aug 13;128(7):721- 8. Open reference URL https://web.pathway.md/studies/recQR5QeanONeTRHr 2/2