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TOPLINE:

In patients with atrial fibrillation (AF) and stable coronary artery disease (CAD), rivaroxaban monotherapy reduced the risks for major cardiovascular events (MACE) and major bleeding across all adult age groups.

METHODOLOGY:

• Researchers performed a post hoc analysis of data from the AFIRE trial, conducted in Japan, to assess the age-stratified effects of rivaroxaban monotherapy vs treatment with rivaroxaban plus an antiplatelet agent.
• The analysis included 2215 patients (mean age, 74.3 years; 79.1% men) with AF and stable CAD more than 1 year after revascularization or angiographically confirmed CAD that did not need revascularization.
• Patients were randomly assigned to 10 mg or 15 mg of rivaroxaban monotherapy, depending on creatinine clearance, or combination therapy involving rivaroxaban plus aspirin or a P2Y12 inhibitor (at the physician’s discretion).
• The patients were stratified into four age groups: younger than 70 years, 70-74 years, 75-79 years, and 80 years or older.
• The primary efficacy endpoint was MACE, defined as a composite of stroke, myocardial infarction, systemic embolism, unstable angina requiring revascularization, or death; the primary safety endpoint was major bleeding. The patients were followed for up to 45 months.

TAKEAWAY:

• Across the age spectrum, rivaroxaban alone matched combination therapy for reducing the risks for MACE and major bleeding.
• However, rivaroxaban monotherapy, compared with combination therapy, was associated with a more pronounced reduction in the risk for MACE among patients aged 80 years or older (hazard ratio [HR], 0.61; 95% CI, 0.40-0.93) and a more pronounced reduction in the risk for major bleeding among those younger than 70 years (HR, 0.23; 95% CI, 0.06-0.79).

IN PRACTICE:

“Although the present study did not clarify the factors involved, it is important to reaffirm that rivaroxaban monotherapy effectively reduces net adverse clinical events, which comprehensively include both thrombotic and hemorrhagic events, across a wide age range, even in older patients,” the researchers reported.

SOURCE:

This study was led by Junichi Yamaguchi, MD, PhD, of the Department of Cardiology at Tokyo Women’s Medical University in Tokyo, Japan. It was published online on August 13, 2025, in JAMA Cardiology.

LIMITATIONS:

The open-label design of the trial may have introduced bias. As a post hoc analysis, this study was underpowered, and differences between the two arms may have been missed due to small sample size. The antiplatelet agent was chosen by the treating physician and was not standardized.

DISCLOSURES:

This study received support from the Japan Cardiovascular Research Foundation through a contract with Bayer Yakuhin, Ltd. Several authors reported receiving grants, personal fees, and endowments from multiple sources, including Bayer, the Ministry of Education, Culture, Sports, Science and Technology of Japan, and Abbott, among others.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.