Context:

Rivaroxaban monotherapy was found to reduce the risk of major cardiovascular events (MACE) and major bleeding in patients with atrial fibrillation (AF) and stable coronary artery disease (CAD) across all age groups in a post hoc analysis of the AFIRE trial. The study included 2215 patients and stratified them into four age categories, revealing that rivaroxaban alone was particularly effective in reducing MACE among those aged 80 and older and major bleeding among those younger than 70. The analysis demonstrated that rivaroxaban monotherapy matches combination therapy in efficacy, despite potential biases due to its open-label design and the lack of standardization in the choice of antiplatelet agents. Despite these limitations, the research underscores the importance of rivaroxaban in managing thrombotic and hemorrhagic events for a broad age range of patients. Conducted in Japan and led by Dr. Junichi Yamaguchi, the study was published in JAMA Cardiology and received support from the Japan Cardiovascular Research Foundation and Bayer Yakuhin, Ltd.

Dive Deeper:

• The AFIRE trial assessed the effectiveness of rivaroxaban monotherapy versus combination therapy with an antiplatelet agent for patients with AF and stable CAD, involving 2215 patients with a mean age of 74.3 years and predominantly male (79.1%).

• Patients were categorized into four age groups: under 70, 70-74, 75-79, and 80 or older, and were randomly assigned rivaroxaban dosages of 10 mg or 15 mg based on creatinine clearance, with combination therapy including aspirin or a P2Y12 inhibitor.

• Rivaroxaban monotherapy reduced MACE and major bleeding risks compared to combination therapy, showing a significant reduction in MACE for those aged 80 and above (HR, 0.61) and in major bleeding for those younger than 70 (HR, 0.23).

• The study emphasized that rivaroxaban effectively reduces net adverse clinical events across a wide age range, addressing both thrombotic and hemorrhagic events, though the factors influencing these outcomes were not clarified.

• The trial's open-label design may have introduced bias, and its post hoc nature meant it was underpowered, potentially missing differences between treatment arms due to the small sample size and non-standardized antiplatelet agent choice.

• Support for the study came from the Japan Cardiovascular Research Foundation, with financial ties to Bayer Yakuhin, Ltd., and other entities, while the article involved AI tools and human editors in its creation.

• Dr. Junichi Yamaguchi, from Tokyo Women's Medical University, led the study, which was published in JAMA Cardiology on August 13, 2025, highlighting the role of rivaroxaban in managing AF and stable CAD events.