Edoxaban Versus Edoxaban With Antiplatelet Agent in Patients With Atrial Fibrillation and Chronic Stable Coronary Artery Disease - EPIC-CAD

Sep 01, 2024
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
CardioVascular Research Foundation
Date Presented:
09/01/2024
Date Published:
09/01/2024
Original Posted Date:
09/01/2024
References

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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