Key result
Edoxaban monotherapy cuts NACE up to ~60% vs dual therapy in AF and CAD across creatinine clearances.
Why the study?
Renal function is a critical factor influencing ischaemic and bleeding risks, prompting evaluation of the impact of renal dysfunction in patients with AF and stable CAD receiving antithrombotic therapy.
Does edoxaban monotherapy reduce net adverse clinical events compared to dual antithrombotic therapy in patients with atrial fibrillation and stable coronary artery disease?
RCT (n=1,040)
randomised
Does edoxaban monotherapy reduce net adverse clinical events compared to dual antithrombotic therapy in patients with atrial fibrillation and stable coronary artery disease?
Effect estimate: HR 0.52 (95% CI 0.28-0.98)
Absolute Event Rate: 12.1% vs 21.7%
p-value: p=0.042
In patients with AF and stable CAD, edoxaban monotherapy is superior to dual antithrombotic therapy for reducing net adverse clinical events, regardless of baseline renal function.
Supports edoxaban monotherapy over dual therapy to reduce NACE in AF with stable CAD; extends randomized evidence across renal function strata.
BACKGROUND: Renal function is a critical factor of ischaemic and bleeding risks in patients with atrial fibrillation (AF) receiving antithrombotic therapy. AIMS: This study aimed to evaluate the impact of renal dysfunction in patients with AF and stable coronary artery disease (CAD) undergoing antithrombotic therapy. METHODS: The Edoxaban Versus Edoxaban With antiPlatelet Agent In Patients With Atrial Fibrillation and Chronic Stable Coronary Artery Disease (EPIC-CAD) trial randomised patients to edoxaban monotherapy or dual antithrombotic therapy (edoxaban plus a single antiplatelet agent). In this prespecified analysis, patients were stratified by creatinine clearance into low (<50 mL/min) or high (≥50 mL/min) groups according to edoxaban dose-reduction criteria. The primary endpoint was net adverse clinical events (NACE: death from any cause, myocardial infarction, stroke, systemic embolism, urgent revascularisation, or major/clinically relevant non-major bleeding) at 12 months. RESULTS: Of 1,040 randomised patients, 252 (24.2%) had low creatinine clearance; these patients were older and had more comorbidities compared with the 788 patients (75.8%) with high creatinine clearance. Patients with low creatinine clearance experienced higher risks of NACE (hazard ratio [HR] 1.72, 95% confidence interval [CI]: 1.19-2.49; p=0.004), ischaemic events (HR 2.70, 95% CI: 1.09-6.70; p=0.032), and bleeding (HR 1.54, 95% CI: 1.01-2.34; p=0.046). At 12 months, edoxaban monotherapy reduced NACE compared with dual therapy in both the low (12.1% vs 21.7%, HR 0.52, 95% CI: 0.28-0.98; p=0.042) and high creatinine clearance groups (5.2% vs 14.5%, HR 0.40, 95% CI: 0.25-0.65; p<0.001), with no interaction (p for interaction=0.53). CONCLUSIONS: In patients with AF and stable CAD, edoxaban monotherapy led to a lower risk of primary NACE than dual antithrombotic therapy, regardless of renal function. (ClinicalTrials.gov: NCT03718559).
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Lee et al. (2026) conducted an RCT in Atrial fibrillation and stable coronary artery disease (n=1,040). Edoxaban monotherapy vs. Dual antithrombotic therapy (edoxaban plus a single antiplatelet agent) was evaluated on Net adverse clinical events (NACE: death from any cause, myocardial infarction, stroke, systemic embolism, urgent revascularisation, or major/clinically relevant non-major bleeding) at 12 months (low creatinine clearance group) (HR 0.52, 95% CI 0.28-0.98, p=0.042). Edoxaban monotherapy reduced NACE compared with dual therapy in patients with AF and stable CAD across both low (HR 0.52; 95% CI 0.28-0.98) and high (HR 0.40; 95% CI 0.25-0.65) creatinine clearance.
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