Age-Stratified Effect of Rivaroxaban Monotherapy for Atrial Fibrillation in Stable Coronary Artery Disease: A Post Hoc Analysis of the AFIRE Randomized Clinical Trial
Authors' conclusion
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.
Study context
- Population
- Patients with atrial fibrillation (AF) and stable coronary artery disease (CAD) (PCI or CABG ≥1 year earlier, or angiographic CAD not requiring revascularization), Japan, 2015–2018; stratified by age (<70, 70–74, 75–79, ≥80 years)
- Participants
- 2,215 patients
- Comparison
- Rivaroxaban monotherapy vs rivaroxaban plus antiplatelet therapy, by age
- Primary endpoint
- MACE:
- Stroke
- Systemic embolism
- MI
- Unstable angina requiring revascularization
- All-cause death
Methodological detailspost hoc, open-label, multicentre, age-stratified
- Post hoc
- Open-label
- Multicentre
- Age-stratified
Primary result
As reported in the abstract
MACE by age subgroup (incidence per patient-year)
Rivaroxaban monotherapy
- <70 years
- 3.2%
- 70-74 years
- 3.2%
- 75-79 years
- 3.8%
- ≥80 years
- 6.2%
Rivaroxaban plus antiplatelet
- <70 years
- 4.3%
- 70-74 years
- 2.8%
- 75-79 years
- 5.3%
- ≥80 years
- 10.3%
<70 years
Rivaroxaban monotherapy3.2%
Rivaroxaban plus antiplatelet4.3%
70-74 years
Rivaroxaban monotherapy3.2%
Rivaroxaban plus antiplatelet2.8%
75-79 years
Rivaroxaban monotherapy3.8%
Rivaroxaban plus antiplatelet5.3%
≥80 years
Rivaroxaban monotherapy6.2%
Rivaroxaban plus antiplatelet10.3%
Rivaroxaban monotherapy vs Rivaroxaban plus antiplateletHazard ratio (95% CI)
<70 years
0.74(0.40–1.37)
70-74 years
1.16(0.55–2.45)
75-79 years
0.72(0.41–1.26)
≥80 years
0.61(0.40–0.93)
Safety
Major bleeding (primary safety end point), rivaroxaban monotherapy vs rivaroxaban plus antiplatelet, by age
- Incidence, <70 years (monotherapy vs combination)
- 0.5% vs 2.3%
- Incidence, 70-74 years (monotherapy vs combination)
- 2.2% vs 2.4%
- Incidence, 75-79 years (monotherapy vs combination)
- 1.1% vs 2.1%
- Incidence, ≥80 years (monotherapy vs combination)
- 2.9% vs 4.3%
- HR, <70 years
- 0.23 (95% CI, 0.06-0.79)
- HR, 70-74 years
- 0.91 (95% CI, 0.39-2.15)
- HR, 75-79 years
- 0.52 (95% CI, 0.19-1.42)
- HR, ≥80 years
- 0.67 (95% CI, 0.35-1.27)
- P for interaction =.33
- Post hoc analysis
Original publication
Age-Stratified Effect of Rivaroxaban Monotherapy for Atrial Fibrillation in Stable Coronary Artery Disease: A Post Hoc Analysis of the AFIRE Randomized Clinical Trial. JAMA Cardiol. Published 13 August 2025. doi:10.
Summarised from the published abstract; every number is checked against it