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Edoxaban vs. Enoxaparin-Warfarin for AF Cardioversion
Study Questions:
What are the safety and efficacy data associated with edoxaban versus enoxaparin-warfarin for patients with atrial fibrillation (AF) who are undergoing cardioversion?
Methods:
ENSURE-AF is a multicenter, prospective, randomized, open-label trial, in which 2,199 patients were randomized to dose-adjusted edoxaban (60 mg as standard dose) versus enoxaparin-warfarin. Randomization was stratified based on use of transesophageal echocardiography (TEE) pre-cardioversion, prior anticoagulant experience, edoxaban dose, and geographic region. The primary efficacy endpoint was a composite of stroke, systemic embolism, myocardial infarction, and cardiovascular mortality over a 28-day follow-up period. The primary safety endpoint was major and clinically relevant nonmajor (CRNM) bleeding with a 58-day follow-up period.
Results:
Between March 2014 and October 2015, patients with AF were randomized to edoxaban (n = 1,095) or enoxaparin-warfarin (n = 1,104), with 1,183 patients undergoing TEE and 1,016 without TEE prior to cardioversion. Mean CHA2DS2-VASc score was 2.6 (standard deviation 1.4). Mean time in the therapeutic range for warfarin-treated patients was 70.8%. The primary efficacy endpoint occurred in five patients (<1%) in the edoxaban group and 11 patients (1%) in the enoxaparin-warfarin group (odds ratio [OR], 0.46; 95% confidence interval [CI], 0.12-1.43). The primary safety endpoint occurred in 16 (1%) of the edoxaban patients versus 11 (1%) of the enoxaparin-warfarin patients (OR, 1.48; 95% CI, 0.64-3.55). The use of TEE or edoxaban dose did not impact the efficacy or safety outcome assessment.
Conclusions:
The authors concluded that overall adverse event rates were rare for AF patients undergoing cardioversion, and that edoxaban was similarly as effective as enoxaparin-warfarin.
Perspective:
As was previously seen in the X-VeRT trial (Eur Heart J 2014;35:3346-55) comparing rivaroxaban to warfarin, this study again demonstrated very low adverse event rates (both thromboembolic and bleeding-related) for AF patients undergoing cardioversion. As we await the results of the EMANATE trial (NCT02100228) comparing apixaban to warfarin, clinicians are increasingly becoming comfortable using direct oral anticoagulants, such as rivaroxaban and edoxaban, for stroke prevention in AF patients undergoing cardioversion.
Keywords: Anticoagulants, Arrhythmias, Cardiac, Atrial Fibrillation, Echocardiography, Transesophageal, Electric Countershock, Embolism, Enoxaparin, Hemorrhage, Myocardial Infarction, Secondary Prevention, Stroke, Warfarin, Thromboembolism, ESC Congress
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