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Stroke and Bleeding Risks with Non-Vitamin K Oral Anticoagulants in Nonvalvular Atrial Fibrillation

Basic Details
Date
Type
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Description

An FDA study using Medicare data concluded that among patients aged 65 years or older with nonvalvular atrial fibrillation (NVAF), rivaroxaban had a less favorable benefit-harm profile compared with other non-vitamin K oral anticoagulants (NOACs); however, it remains unclear whether this finding persists in younger users. This cohort study aimed to examine the comparative safety and effectiveness of the rivaroxaban, apixaban and dabigatran, among those younger than 65 years with NVAF in the FDA Sentinel System.  

Materials

JAMA Netw Open. 2026 Apr 24. DOI.org 10.1001/jamanetworkopen.2026.9082

Related Assessment(s)
Sentinel Drug Study: Eliquis (Apixaban), Pradaxa (Dabigatran), and Xarelto (Rivaroxaban) & Gastrointestinal Bleeding, Intracranial Hemorrhage, Major Extracranial Bleeding, and Thromboembolic Stroke
Sentinel Drug Analysis: Characteristics and Drug Utilization in Dabigatran, Rivaroxaban, and Apixaban Initiators Aged 64 or Younger: A Descriptive Analysis
Sentinel Drug Analysis: Occurrence of Stroke, Intracranial Hemorrhage, and Bleeding Outcomes Following Direct Oral Anticoagulant Use in Patients Aged 64 or Younger with Atrial Fibrillation: A Descriptive Analysis
Sentinel Drug Analysis: Thromboembolic Stroke, Intracranial Hemorrhage, Gastrointestinal Bleeding, & Major Extracranial Bleeding Following Apixaban, Dabigatran, and Rivaroxaban Use in Patients Aged 64 Years and Younger with Atrial Fibrillation: An IPTW...
Sentinel Drug Analysis: Thromboembolic Stroke, Intracranial Hemorrhage, Gastrointestinal Bleeding, and Major Extracranial Bleeding following Dabigatran, Rivaroxaban, and Apixaban Use in Patients Aged 64 and Younger with Atrial Fibrillation: A PSM Analysis
Sentinel Presentation: Characteristics of NOAC Users Aged Less Than 65 Years in the Sentinel System
Sentinel Presentation: Replicating the Findings of a Medicare Study on Stroke, and Bleeding Risk in Patients Using NOACs for Atrial Fibrillation in the Sentinel System
Author(s)

Marie C. Bradley, Andrew L. Simon, Joy Kolonoski, David J. Graham, Rongmei Zhang, John G. Connolly

Corresponding Author

Marie C. Bradley; Office of Medical Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland

Email: marie.bradley@fda.hhs.gov