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Sex-Based Differences in Clinical Outcomes With Edoxaban Therapy: A Prespecified Analysis of the EPIC-CAD Trial

Gi-Hwan Kim1, MinSoo Cho1, Seonok Kim2

  • 1Department of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.

JACC. Asia
|February 28, 2026
PubMed

Insights

Edoxaban monotherapy reduced net adverse clinical events in men with atrial fibrillation and coronary artery disease, but not in women. Further research is needed for sex-specific antithrombotic strategies.

Area of Science:

  • Cardiology
  • Pharmacology
  • Clinical Trials

Background:

  • Sex-based differences in atrial fibrillation (AF) and coronary artery disease (CAD) characteristics and prognosis are established.
  • Optimal antithrombotic therapy strategies in patients with both AF and CAD, considering sex, remain unclear.

Purpose of the Study:

  • To evaluate the efficacy and safety of edoxaban monotherapy versus dual antithrombotic therapy (edoxaban plus antiplatelet) in patients with AF and stable CAD.
  • To analyze treatment outcomes stratified by sex.

Main Methods:

  • A substudy of the EPIC-CAD trial compared edoxaban monotherapy to dual antithrombotic therapy.
  • The primary outcome was net adverse clinical events (NACE) at 12 months.
  • Patients included had AF with stable CAD.

Main Results:

  • Edoxaban monotherapy significantly reduced NACE in men compared to dual therapy (aHR: 0.36; P < 0.001).
  • This reduction was not observed in women (aHR: 0.74; P = 0.455).
  • No significant interaction between treatment and sex was found (P=0.09).

Conclusions:

  • Edoxaban monotherapy demonstrated efficacy in reducing NACE in men but not in women with AF and stable CAD.
  • Current data suggest a potential sex-specific response to antithrombotic strategies.
  • Further investigation is warranted to develop tailored antithrombotic approaches for diverse patient populations.
Abstract

Keywords:
anticoagulationatrial fibrillationcoronary artery diseasesex difference

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