Rivaroxaban Monotherapy Benefits Those with Atrial Fibrillation, Stable Coronary Artery Disease

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Rivaroxaban monotherapy for atrial fibrillation results in consistent clinical benefits across all age cohorts, new findings suggest, and this is especially true among older patients with atrial fibrillation and stable coronary artery disease (CAD).1

Such findings were the result of a recent study published in JAMA. Junichi Yamaguchi, MD, PhD, from the Department of Cardiology at Tokyo Women’s Medical University, led a team of investigators in this analysis.

They highlighted that prior data from the AFIRE study in Japan had shown that compared with combination therapy with rivaroxaban and an antiplatelet agent, rivaroxaban was equally efficacious as a monotherapy for preventing cardiovascular events and reducing bleeding risk in those with atrial fibrillation and stable CAD.2 However, Yamaguchi and colleagues also highlighted the lack of an age-specific analysis of adults who have atrial fibrillation and are undergoing percutaneous coronary intervention (PCI) before their current study.

“Thus, this study aimed to examine the age-stratified efficacy and safety of rivaroxaban monotherapy vs those of rivaroxaban plus antiplatelet agent combination therapy,” Yamaguchi et al wrote.1 “To achieve this goal, we undertook a post hoc analysis of the AFIRE trial data.”

AFIRE Trial Design

The investigative team carried out what became a post-hoc secondary analysis of the Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease (AFIRE) analysis. AFIRE itself was designed as an open-label, randomized clinical study that was carried out at multiple centers in Japan between February 2015 – July 2018.

AFIRE’s investigators enrolled individuals with atrial fibrillation as well as stable CAD. Those deemed eligible to participate either had undergone PCI or coronary artery bypass grafting (CABG) at least a single year beforehand or had angiographically confirmed CAD that did not require revascularization. Yamaguchi et al categorized those taking part in the analysis into 1 of 4 age cohorts: those aged <70 years, 70–74 years, 75–79 years, and ≥80 years.

The investigative team’s analysis of available data on these trial subjects was conducted in the period between August 2024 – July 2025. They compared the results of rivaroxaban as a monotherapy to the results of rivaroxaban combined with an antiplatelet agent. In terms of primary efficacy outcomes, the team looked at occurrences of a major adverse cardiovascular event (MACE).

Examples of MACEs included myocardial infection, stroke, systemic embolism, unstable angina necessitating revascularization, or mortality due to any cause. The primary safety endpoint evaluated by Yamaguchi and colleagues was major bleeding. They included 2,215 individuals in total, all of which had a mean age of 74.3 years and 79.1% of whom were labeled as male.

Findings on Rivaroxaban Monotherapy

In their evaluation of incidence rates of primary efficacy events per patient-year for rivaroxaban monotherapy compared with combination therapy, Yamaguchi and coauthors determined that rates for each of the aforementioned age cohorts were the following, respectively:

  • 3.2% versus 4.3% (<70 years)
  • 3.2% versus 2.8% (70–74 years)
  • 3.8% versus 5.3% (75–79 years)
  • 6.2% versus 10.3% (≥80 years)

Corresponding hazard ratios (HRs) for each of the age cohorts on rivaroxaban monotherapy were shown to be .74 (95% CI, .40–1.37) for participants aged <70 years, 1.16 (95% CI, .55–2.45) for those aged 70–74 years, .72 (95% CI, .41–1.26) for those aged 75–79 years, and .61 (95% CI, .40–.93) for those aged ≥80 years (P = .51).

In their assessment of primary safety outcomes, Yamaguchi et al found that the incidence of major bleeding per patient-year with monotherapy as opposed to combination therapy were the following, respectively:

  • 0.5% versus 2.3% (<70 years)
  • 2.2% versus 2.4% (70–74 years)
  • 1.1% versus 2.1% (75–79 years)
  • 2.9% versus 4.3% (≥80 years)

HRs were noted by the investigators to be .23 (95% CI, .06–.79) for the <70 year cohort, .91 (95% CI, .39–2.15) for the 70–74 year cohort, .52 (95% CI, .19–1.42) for the 75–79 cohort, and .67 (95% CI, .35–1.27) for those in the ≥80 year cohort (P = .33).

“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,” they concluded.1

References

  1. Yamaguchi J, Arashi H, Hagiwara N, et al. 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 online August 13, 2025. doi:10.1001/jamacardio.2025.2611.
  2. Yasuda S, Kaikita K, Akao M, et al; AFIRE Investigators. Antithrombotic therapy for atrial fibrillation with stable coronary disease. N Engl J Med. 2019;381(12):1103-1113. doi:10.1056/NEJMoa1904143.

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