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Published on: July 20, 2022
Edoxaban for the prevention of stroke in patients with atrial fibrillation
Carlos Escobar Cervantes1, José Luis Merino1, Vivencio Barrios2
1a Cardiology Service, Unidad de electrofisiología cardíaca robotizada , Hospital Universitario La Paz , Madrid , Spain.
Insights
Edoxaban is a direct oral anticoagulant proven effective in preventing stroke in nonvalvular atrial fibrillation (AF) patients. It demonstrates non-inferiority to warfarin with a significant reduction in bleeding events and cardiovascular mortality.
Area of Science:
- Cardiology
- Pharmacology
- Thrombosis
Background:
- Edoxaban is a recently marketed direct oral anticoagulant for stroke prevention in nonvalvular atrial fibrillation (AF).
- The ENGAGE AF-TIMI 48 trial was pivotal for edoxaban's approval, with subsequent numerous substudies and real-world data emerging.
- This review synthesizes current evidence on edoxaban's use in AF patients.
Purpose of the Study:
- To provide an updated review of the efficacy and safety of edoxaban in patients with atrial fibrillation.
- To consolidate findings from the pivotal ENGAGE AF-TIMI 48 trial and subsequent real-world evidence.
Main Methods:
- Review of the pivotal ENGAGE AF-TIMI 48 clinical trial data.
- Analysis of published substudies, post hoc analyses, and observational studies.
- Synthesis of real-world data on edoxaban effectiveness and safety in AF patients.
Main Results:
- Edoxaban 60 mg was non-inferior to warfarin for preventing stroke or systemic embolism in AF patients.
- Edoxaban significantly reduced the risk of bleeding, major adverse cardiac events, and cardiovascular death compared to warfarin.
- Efficacy and safety were consistent across various patient subgroups and clinical conditions.
Conclusions:
- Edoxaban is a safe and effective alternative to warfarin for stroke prevention in nonvalvular AF.
- Real-world data, though limited, align with clinical trial findings, supporting edoxaban's established profile.
- Edoxaban presents a cost-effective option for AF patients at moderate to high risk of thromboembolism.
Introduction:
Edoxaban is the last direct oral anticoagulant marketed for the prevention of stroke among patients with nonvalvular atrial fibrillation (AF). Areas covered: ENGAGE AF-TIMI 48 was the pivotal clinical trial that led to the approval of edoxaban 60 mg once daily. After the publication of this study, a great number of substudies and post hoc analyses have been published, together with some observational studies. The aim of this review was to update the current evidence about the use of edoxaban in AF patients. Expert opinion: In the ENGAGE AF-TIMI 48 trial, edoxaban 60 mg was noninferior to warfarin for the prevention of stroke or systemic embolism, but significantly reduced the risk of bleeding, major adverse cardiac events and death from cardiovascular causes. The relative efficacy and safety of edoxaban 60 mg compared with warfarin were independent of different clinical conditions, such as prior stroke, age, risk of falls, renal function, hepatic disease, ischemic heart disease, heart failure, valvular heart disease, or cancer. Data about the effectiveness and safety of edoxaban in real-life patients are scarce, but consistent with those of the pivotal clinical trial. Edoxaban seems a cost-effective alternative to warfarin among AF patients with moderate to high thromboembolic risk.
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