Edoxaban for the prevention of stroke in patients with atrial fibrillation

ABSTRACT

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.

KEYWORDS:

• Atrial fibrillation
• bleeding
• ENGAGE AF–TIMI 48
• edoxaban
• stroke

Article highlights

• Edoxaban is a once-daily oral inhibitor of factor Xa, currently indicated for the prevention of stroke or systemic embolism in patients with nonvalvular AF.

• The ENGAGE AF–TIMI 48 trial showed that 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 (stroke/systemic embolism) and safety (major bleeding) of edoxaban 60 mg compared with warfarin were independent of different clinical conditions (i.e. prior stroke/transient ischemic attack, age, risk of falls, renal function, hepatic disease, ischemic heart disease, heart failure, valvular heart disease, cancer).

• Since edoxaban is the last DOAC marketed, 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 nonvalvular AF patients with moderate to high thromboembolic risk.

Declaration of interest

C. Escobar reports personal fees from Bayer, Boehringer, Bristol- Myers Squibb, Daichii-Sankyo, and Pfizer outside the submitted work. JL Merino reports personal fees as speaker for Bayer and Daichii-Sankyo. V Barrios has received lecturing fees from Boehringer Ingelheim, Bayer, Daiichi Sankyo, Pfizer/Bristol-Myers Squibb, consulting fees for participating in advisory boards from Boehringer Ingelheim, Bayer, Daiichi Sankyo and grants from Pfizer and Bristol-Myers Squibb.

Writing and editorial assistance was provided by Content Ed Net (Madrid, Spain) with funding from Daiichi Sankyo.

Reviewer Disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose

Additional information

Funding

This paper was funded by Daichii-Sankyo.