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Age-Stratified Effect of Rivaroxaban Monotherapy for Atrial Fibrillation in Stable Coronary Artery Disease: A Post
Junichi Yamaguchi1, Hiroyuki Arashi1, Nobuhisa Hagiwara1
1Department of Cardiology, Tokyo Women's Medical University, Tokyo, Japan.
Insights
Rivaroxaban monotherapy effectively reduced cardiovascular events and bleeding in older patients with coronary artery disease (CAD) and atrial fibrillation (AF). Age-related differences in efficacy and safety warrant further investigation.
Area of Science:
- Cardiology
- Pharmacology
- Geriatrics
Background:
- Antithrombotic therapy is essential for patients with coronary artery disease (CAD) and atrial fibrillation (AF), who face high risks of bleeding and thrombotic events.
- Older adults with these conditions require careful consideration of treatment strategies to balance efficacy and safety.
Purpose of the Study:
- To evaluate the age-stratified efficacy and safety of rivaroxaban monotherapy versus combination therapy (rivaroxaban plus antiplatelet agent) in patients with AF and stable CAD.
- To determine if treatment effects differ across various age groups.
Main Methods:
- A post hoc analysis of the AFIRE open-label randomized clinical trial involving 2215 patients with AF and stable CAD.
- Participants were stratified into four age groups: <70, 70-74, 75-79, and ≥80 years.
- Primary efficacy endpoint: major adverse cardiovascular events. Primary safety endpoint: major bleeding.
Main Results:
- Rivaroxaban monotherapy showed a trend towards reduced major cardiovascular events across age groups, with a significant reduction in those aged ≥80 years (HR 0.61).
- Rivaroxaban monotherapy significantly reduced major bleeding events, particularly in patients younger than 70 years (HR 0.23).
- No significant interaction was observed between age and treatment effect for either efficacy or safety endpoints.
Conclusions:
- Rivaroxaban monotherapy appears to be a viable option for patients with AF and stable CAD, offering benefits in both cardiovascular event reduction and bleeding risk mitigation across a wide age range.
- While trends suggest potential age-related nuances in efficacy and safety, further research is needed to confirm these findings and guide personalized treatment strategies.
- The study highlights the importance of considering individual patient factors, including age, when selecting antithrombotic therapy.
Importance:
Antithrombotic therapy is crucial for older patients with coronary artery disease (CAD) and atrial fibrillation (AF) who are at a high risk of bleeding and thrombotic events.
Objective:
To examine the age-stratified effects of rivaroxaban monotherapy compared with those of rivaroxaban plus antiplatelet agent combination therapy.
Design, Setting, And Participants:
This was a post hoc secondary analysis of the Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease (AFIRE) open-label randomized clinical trial. This was a multicenter study conducted in Japan from February 23, 2015, to July 31, 2018. Patients with AF and stable CAD who had undergone percutaneous coronary intervention or coronary artery bypass grafting 1 or more years earlier or who had angiographically confirmed CAD that did not require revascularization were enrolled. Participants were stratified into 4 groups by age (<70 years, 70-74 years, 75-79 years, and ≥80 years). Study data were analyzed from August 2024 to July 2025.
Interventions:
Rivaroxaban monotherapy or rivaroxaban plus antiplatelet agent therapy.
Main Outcomes And Measures:
The primary efficacy end point was a major adverse cardiovascular event, defined as a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, or death from any cause. The primary safety end point was major bleeding.
Results:
This study included a total of 2215 participants (mean [SD] age, 74.3 [8.2] years; 1751 male [79.1%]). The incidence of primary efficacy end points per patient-year for rivaroxaban monotherapy vs rivaroxaban plus antiplatelet agent therapy was 3.2% vs 4.3% (<70 years), 3.2% vs 2.8% (70-74 years), 3.8% vs 5.3% (75-79 years), and 6.2% vs 10.3% (≥80 years). The hazard ratios were 0.74 (95% CI, 0.40-1.37) for those younger than 70 years, 1.16 (95% CI, 0.55-2.45) for those aged 70 to 74 years, 0.72 (95% CI, 0.41-1.26) for those aged 75 to 79 years, and 0.61 (95% CI, 0.40-0.93) for those 80 years and older (P for interaction =.51). For the primary safety end points, the incidence was 0.5% vs 2.3% (<70 years), 2.2% vs 2.4% (70-74 years), 1.1% vs 2.1% (75-79 years), and 2.9% vs 4.3% (≥80 years). The hazard ratios were 0.23 (95% CI, 0.06-0.79) for those younger than 70 years, 0.91 (95% CI, 0.39-2.15) for those aged 70 to 74 years, 0.52 (95% CI, 0.19-1.42) for those aged 75 to 79 years, and 0.67 (95% CI, 0.35-1.27) for those 80 years and older (P for interaction =.33).
Conclusions And Relevance:
Results of this post hoc analysis of the AFIRE randomized clinical trial reveal that rivaroxaban monotherapy reduced the risk of major cardiovascular events and major bleeding across the broad range of age in patients with AF and stable CAD. Possible age-related differences in trends, with more pronounced efficacy in older patients and more pronounced safety in younger patients, should be considered as hypothesis generating and require further research.
Trial Registration:
ClinicalTrials.gov Identifier: NCT02642419.
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