Apixaban Lowers Stroke Risk in Atrial Fibrillation Patients Undergoing Cardioversion - EMANATE
Contribution To Literature:
The EMANATE trial showed that short-duration apixaban was feasible in patients with atrial fibrillation undergoing cardioversion.
The goal of the trial was to evaluate short-duration apixaban compared with warfarin with among patients with atrial fibrillation undergoing cardioversion.
Patients with predominately new-onset atrial fibrillation undergoing cardioversion were randomized to short-duration (<48 hours) apixaban 5 mg twice daily (n = 753) versus heparin/warfarin (n = 747). Patients randomized to apixaban could receive a 10 mg loading dose and undergo cardioversion after 2 hours. Transesophageal echocardiography (TEE) was encouraged, but not mandated. Approximately 50% of the patients underwent TEE prior to cardioversion.
- Total number of enrollees: 1,500
- Duration of follow-up: 30 days
- Mean patient age: 65 years
- Percentage female: 33%
- Percentage with diabetes: 21%
- Anticoagulation-naïve patients with atrial fibrillation
- Scheduled for cardioversion
- Contraindication to anticoagulation
- Mitral stenosis or previous valve surgery
- Other condition requiring anticoagulation
- On dual antiplatelet therapy
The primary outcome, incidence of stroke or systemic embolism, occurred in 0% of the apixaban group versus 0.8% of the heparin/warfarin group (p = 0.016).
- Major bleeding: 0.4% of the apixaban group vs. 0.8% of the heparin/warfarin group
- Clinically relevant nonmajor bleeding: 1.5% of the apixaban group vs. 1.8% of the heparin/warfarin group
- Thrombus was present among 7.2% (61 of 840) of patients who underwent a TEE. Among those who underwent repeat imaging, approximately 1 month later, thrombi resolved in 52% of the apixaban group and 56% of the heparin/warfarin group.
Among patients with atrial fibrillation, short-duration apixaban (<48 hours) is feasible compared with short-duration heparin/warfarin. Short-duration apixaban was associated with a lower frequency of stroke or systemic embolism and similar incidence of bleeds compared with heparin/warfarin. This approach does not obviate the need for TEE since imaging disclosed approximately 7% of patients with thrombi, of which only one half had resolved by 1 month.
Ezekowitz MD, Pollack CV Jr, Halperin JL, et al. Apixaban compared to heparin/vitamin K antagonist in patients with atrial fibrillation scheduled for cardioversion: the EMANATE trial. Eur Heart J 2018;Apr 6:[Epub ahead of print].
Presented by Dr. Michael D. Ezekowitz at the European Society of Cardiology Congress, Barcelona, Spain, August 28, 2017.
Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Noninvasive Imaging, Prevention, Anticoagulation Management and Atrial Fibrillation, Implantable Devices, EP Basic Science, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Echocardiography/Ultrasound
Keywords: Arrhythmias, Cardiac, Atrial Fibrillation, Anticoagulants, Echocardiography, Transesophageal, Electric Countershock, Embolism, ESC2017, ESC Congress, Hemorrhage, Heparin, Secondary Prevention, Stroke, Thrombosis, Warfarin
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