Stroke and Bleeding Risks With Non–Vitamin K Oral Anticoagulants in Nonvalvular Atrial Fibrillation

Does rivaroxaban have a less favorable benefit-harm profile compared with other non–vitamin K oral anticoagulants (NOACs) in patients younger than 65 years treated for atrial fibrillation?In this cohort study of more than 173 000 patients with nonvalvular atrial fibrillation across 3 exposure cohorts, rivaroxaban use was associated with an increased risk of major extracranial and gastrointestinal bleeding, as well as a marginally increased risk of intracranial hemorrhage compared with apixaban. Thromboembolic stroke risk was similar in apixaban and rivaroxaban users, but higher risks were seen in dabigratan users compared with both.These findings suggest, for NOAC users younger than 65 years, rivaroxaban may provide greater protection against thromboembolic stroke than dabigatran but is less favorable than apixaban due to increased bleeding risks.

Corresponding Author: Marie C. Bradley, PhD, Office of Medical Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20903 (marie.bradley@fda.hhs.gov).

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