Sex-Based Differences in Clinical Outcomes With Edoxaban Therapy

Figures

• 

  Figure 1. Patient Enrollment, Randomization, and Follow-Up by Sex A study flow diagram of patients stratified by edoxaban monotherapy and dual antithrombotic therapy is provided. Only patients who survived, did not withdraw, and were not lost to follow-up at 12 months post randomization were included. Percentages may not total 100% due to rounding. EPIC-CAD = Edoxaban Versus Edoxaban With Antiplatelet Agent in Patients With Atrial Fibrillation and Chronic Stable Coronary Artery Disease.

• 

  Figure 2. Kaplan-Meier Curves by Sex for Primary and Secondary Outcomes Primary outcome refers to the net adverse outcome, which includes death from any cause, myocardial infarction, stroke, systemic embolism, unplanned procedures, and major or clinically relevant nonmajor bleeding. Secondary outcomes included major ischemic events and clinically relevant bleeding. Kaplan-Meier curves show the cumulative incidence of the primary outcome over 12 months, stratified by sex. Statistical significance was assessed using multivariable Cox regression analyses, adjusted for clinically relevant covariates, including age, body mass index, CHA2DS2-VASc score, HAS-BLED score, history of prior coronary revascularization, and the presence of edoxaban dose-reduction criteria.

• 

  Figure 3. Kaplan-Meier Analysis of Outcomes by Sex and Edoxaban Therapy This figure compares the primary endpoint (net adverse outcomes) between edoxaban monotherapy and dual antithrombotic therapy, as well as secondary outcomes, including ischemic events and major bleeding, in both women and men, using Kaplan-Meier curves. Statistical significance was assessed using multivariable Cox regression analyses, as detailed in Figure 2.

• 

  Central Illustration. Sex-Based Clinical Outcomes With Edoxaban in Atrial Fibrillation and Coronary Artery Disease This figure shows the sex-specific breakdown and differences in characteristics of the EPIC-CAD trial. In men, there is a significant difference in primary net adverse clinical events between dual therapy and monotherapy. CAD = coronary artery disease; EPIC-CAD = Edoxaban Versus Edoxaban With Antiplatelet Agent in Patients With Atrial Fibrillation and Chronic Stable Coronary Artery Disease Trial; MI = myocardial infarction.