Edoxaban Versus Edoxaban With Antiplatelet Agent in Patients With Atrial Fibrillation and Chronic Stable Coronary Artery Disease - EPIC-CAD
Contribution To Literature:
The EPIC-CAD trial showed that edoxaban monotherapy was superior to edoxaban/antiplatelet therapy at preventing major adverse ischemic/bleeding events.
Description:
The goal of the trial was to evaluate edoxaban monotherapy compared with edoxaban/antiplatelet therapy among patients with atrial fibrillation (AF) and chronic coronary disease.
Study Design
- Randomized
- Parallel
- Open-label
Patients with AF and chronic coronary disease were randomized to edoxaban monotherapy (n = 524) versus edoxaban/antiplatelet therapy (n = 516). The dose of edoxaban was 60 mg daily. The dose could be reduced to 30 mg daily if there was severe renal impairment.
- Total number of enrollees: 1,040
- Duration of follow-up: 12 months
- Mean patient age: 72 years
- Percentage female: 23%
- Percentage with diabetes: 43%
Inclusion criteria:
- Chronic coronary disease, defined as coronary revascularization ≥6 months before enrollment for stable disease or ≥12 months for acute coronary syndrome, or medically managed coronary disease
- Prevalent or paroxysmal AF
Exclusion criteria:
- High bleeding risk
- Intracranial hemorrhage
- Prosthetic heart valve
- Moderate-to-severe mitral stenosis
- Severe hepatic dysfunction
- Severe renal insufficiency
Other salient features/characteristics:
- Mean CHA2DS2-VASc score: 4.3
- Previous coronary revascularization: 64%
- Medically managed coronary artery disease: 34.3%
Principal Findings:
The primary outcome, all-cause mortality, myocardial infarction, stroke, systemic embolism, urgent revascularization, or major bleeding at 12 months, was: 6.8% in the edoxaban group vs. 16.2% in the edoxaban/antiplatelet agent group (p < 0.001).
Secondary outcomes:
- Major bleeding or clinically relevant nonmajor bleeding: 4.7% in the edoxaban group vs. 14.2% in the edoxaban/antiplatelet agent group
- Major adverse cardiac events: 1.6% in the edoxaban group vs. 1.8% in the edoxaban/antiplatelet agent group
Interpretation:
Among patients with AF and chronic coronary disease, edoxaban monotherapy was beneficial. Edoxaban monotherapy versus edoxaban/antiplatelet therapy was associated with a reduction in major adverse cardiac/bleeding events. Importantly, major adverse ischemic events were similar between treatment groups. Benefit was due to major bleeding, which was significantly reduced in the edoxaban monotherapy group versus edoxaban/antiplatelet therapy group. These results are in line with the AFIRE trial, which compared rivaroxaban monotherapy versus rivaroxaban/antiplatelet therapy. Both of these trials were conducted exclusively in Asian individuals, which could limit the generalizability of the findings.
References:
Cho MS, Kang DY, Ahn JM, et al., for the EPIC-CAD Investigators. Edoxaban Antithrombotic Therapy for Atrial Fibrillation and Stable Coronary Artery Disease. N Engl J Med 2024;Sep 1:[Epub ahead of print].
Editorial: Lip GY. Atrial Fibrillation and Stable Coronary Artery Disease. N Engl J Med 2024;Sep 1:[Epub ahead of print].
Presented by Dr. Gi-Byoung Nam at the European Society of Cardiology Congress, London, UK, September 1, 2024.
Clinical Topics: Arrhythmias and Clinical EP, Atherosclerotic Disease (CAD/PAD), Atrial Fibrillation/Supraventricular Arrhythmias
Keywords: Atrial Fibrillation, Coronary Artery Disease, Ischemia, Platelet Aggregation Inhibitors, ESC Congress, ESC24
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