EPIC-CAD
Trial question
What is the role of edoxaban monotherapy in patients with AF and stable coronary artery disease?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
23.0% female
77.0% male
N = 1040
1040 patients (238 female, 802 male).
Inclusion criteria: patients with AF and stable coronary artery disease.
Key exclusion criteria: thrombocytopenia; high risk of bleeding prohibiting anticoagulant use; history of ICH; mechanical prosthetic valve or moderate-to-severe MS; severe hepatic dysfunction; severe renal insufficiency.
Interventions
N=524 edoxaban monotherapy (60 mg once daily).
N=516 dual antithrombotic therapy (edoxaban 60 mg once daily plus a single antiplatelet agent).
Primary outcome
Net adverse clinical events consitisting of death from any cause, MI, stroke, systemic thromboembolic event, unplanned urgent revascularization, or major bleeding or clinically relevant nonmajor bleeding at 12 months
6.8%
16.2%
16.2 %
12.1 %
8.1 %
4.0 %
0.0 %
Edoxaban
monotherapy
Dual antithrombotic
therapy
Significant
decrease ▼
NNT = 10
Significant decrease in net adverse clinical events consitisting of death from any cause, MI, stroke, systemic thromboembolic event, unplanned urgent revascularization, or major bleeding or clinically relevant nonmajor bleeding at 12 months (6.8% vs. 16.2%; HR 0.44, 95% CI 0.3 to 0.65).
Secondary outcomes
No significant difference in major ischemic events (1.6% vs. 1.8%; HR 1.23, 95% CI 0.48 to 3.1).
No significant difference in death from any cause (0.6% vs. 0.7%; HR 1.29, 95% CI 0.29 to 5.76).
No significant difference in stroke (1.4% vs. 0.8%; AD 0.6%, 95% CI -0.69 to 1.89).
Safety outcomes
No significant difference in ICH.
Significant difference in major bleeding or clinically relevant nonmajor bleeding (4.7% vs. 14.2%).
Conclusion
In patients with AF and stable coronary artery disease, edoxaban monotherapy was superior to dual antithrombotic therapy with respect to net adverse clinical events consitisting of death from any cause, MI, stroke, systemic thromboembolic event, unplanned urgent revascularization, or major bleeding or clinically relevant nonmajor bleeding at 12 months.
Reference
Min Soo Cho, Do-Yoon Kang, Jung-Min Ahn et al. Edoxaban Antithrombotic Therapy for Atrial Fibrillation and Stable Coronary Artery Disease. N Engl J Med. 2024 Dec 5;391(22):2075-2086.
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