Edoxaban monotherapy significantly reduced the risk of major or clinically relevant non-major bleeding compared to edoxaban plus antiplatelet therapy (RR 0.33; 95% CI 0.21-0.51; P<0.0001).
Meta-Analysis (n=1,187)
Does edoxaban monotherapy reduce major or clinically relevant non-major bleeding in patients with stable coronary artery disease and non-valvular atrial fibrillation compared to combination edoxaban and antiplatelet therapy?
In patients with stable coronary artery disease and non-valvular atrial fibrillation, edoxaban monotherapy significantly reduces bleeding risk without increasing ischemic events compared to dual antithrombotic therapy.
Effect estimate: RR 0.33 (95% CI 0.21-0.51)
Absolute Event Rate: 4.2% vs 12.7%
p-value: p=<0.0001
Abstract Introduction In patients with ACS or post-percutaneous coronary intervention (PCI), standard treatment is dual antiplatelet therapy (DAPT) with aspirin and an oral P2Y12 inhibitor, for a duration of 12 months after ACS (with or without PCI) or 6 months after CCS-PCI. A state of stable coronary artery disease is achieved in these patients 6-12 months after an optimal medical therapy based on the latest contemporary guidelines. Studies regarding optimal antithrombotic strategy are emerging with the goal of minimizing ischemic events as well as bleeding events. With the goal of minimizing bleeding events, direct oral anticoagulants(DOAC) are recommended as monotherapy for patients with stable coronary artery disease and atrial fibrillation (AF). Methods We pooled data from randomized trials that included patients with stable coronary artery disease and non-valvular atrial fibrillation who received edoxaban monotherapy versus combination edoxaban and antiplatelet therapy. The primary outcome was major bleeding or clinically relevant non major bleeding defined according to the ISTH. The secondary end point was minor bleeding, death of any cause and composite of death, myocardial infarction, stent thrombosis, urgent revascularization and stroke. Results were expressed as risk ratios at 95% confidence interval. Results The pooled cohort (n=1187) had a mean age of 72.3 years and 78% were male. Edoxaban monotherapy is associated with a 67% reduction in the risk of major bleeding or clinically relevant non-major bleeding compared to edoxaban combined with antiplatelet therapy. (4.2% versus 12.7%; risk ratio, 0.33 95% CI, 0.21–0.51; Pvalue 0.0001). Death of any cause and composite of death, myocardial infarction, stent thrombosis, urgent revascularization and stroke were not significantly different between groups. DISCUSSION Among patients with non-valvular atrial fibrillation and stable coronary artery disease, edoxaban monotherapy has demonstrated a significant reduction in bleeding events with no significant increase in ischemic events as compared with combination of edoxaban and an antiplatelet.
Go et al. (2025) conducted a meta-analysis in Stable coronary artery disease and non-valvular atrial fibrillation (n=1,187). Edoxaban monotherapy vs. Combination edoxaban and antiplatelet therapy was evaluated on Major bleeding or clinically relevant non major bleeding defined according to the ISTH (RR 0.33, 95% CI 0.21-0.51, p=<0.0001). Edoxaban monotherapy significantly reduced the risk of major or clinically relevant non-major bleeding compared to edoxaban plus antiplatelet therapy (RR 0.33; 95% CI 0.21-0.51; P<0.0001).