• Ghadeer K Dawwas, Adam Cuker, Geoffrey D Barnes, James D Lewis, and Sean Hennessy.
• Center for Real-world Effectiveness and Safety of Therapeutics, Center for Clinical Epidemiology and Biostatistics, Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, and Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania (G.K.D.).
• Ann. Intern. Med. 2022 Nov 1; 175 (11): 150615141506-1514.

BackgroundAlthough apixaban and rivaroxaban are commonly used in patients with atrial fibrillation (AF) and valvular heart disease (VHD), there is limited evidence comparing the 2 drugs in these patients.ObjectiveTo emulate a target trial of effectiveness and safety of apixaban and rivaroxaban in patients with AF and VHD.DesignNew-user, active comparator, cohort study design.SettingCommercial health insurance database from 1 January 2013 to 31 December 2020.PatientsNew users of apixaban or rivaroxaban who had a diagnosis of AF and VHD before initiation of anticoagulant therapy.MeasurementsThe primary effectiveness outcome was a composite of ischemic stroke or systemic embolism. The primary safety outcome was a composite of gastrointestinal or intracranial bleeding. Cox proportional hazards regression with a robust variance estimator was used to estimate hazard ratios (HRs) and 95% CIs.ResultsWhen compared with rivaroxaban in a propensity score-matched cohort of 19 894 patients (9947 receiving each drug), apixaban was associated with a lower rate of ischemic stroke or systemic embolism (HR, 0.57 [95% CI, 0.40 to 0.80]) and bleeding (HR, 0.51 [CI, 0.41 to 0.62]). The absolute reduction in the probability of stroke or systemic embolism with apixaban compared with rivaroxaban was 0.0026 within 6 months and 0.011 within 1 year of treatment initiation. The absolute reduction in the probability of bleeding events with apixaban compared with rivaroxaban was 0.012 within 6 months and 0.019 within 1 year of treatment initiation.LimitationShort follow-up time and inability to ascertain some types of VHD.ConclusionIn this study of patients with AF and VHD, patients receiving apixaban had a lower risk for ischemic stroke or systemic embolism and for bleeding when compared with those receiving rivaroxaban.Primary Funding SourceNational Institutes of Health.

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