EMANATE: Apixaban vs. Warfarin in AFib Patients Undergoing Cardioversion
Findings from the EMANATE trial presented at ESC Congress 2017 in Barcelona suggest the use of apixaban lowers the risk of stroke compared with warfarin in patients with atrial fibrillation (AFib) undergoing cardioversion. Bleeding rates were similar across both the apixaban and warfarin groups.
Researchers randomized 1,500 AFib patients to either apixaban or parenteral heparin with warfarin. Patients in the apixaban group received a dose of 5 mg twice daily (or 2.5 mg twice a day when two of the following conditions were met: age ≥80 years, weight ≤60 kg, or serum creatinine ≥1.5 mg/dl). At the discretion of the local investigator, patients could also receive an initial 10 mg or 5 mg loading dose of apixaban (for study doses of 5 mg and 2.5 mg, respectively) if cardioversion was immediate.
In comparing the rates of stroke, systemic embolism, death, major bleeding and clinically relevant non-major bleeding between both groups, fewer strokes and similar bleeding were observed in patients treated with apixaban compared with those treated with warfarin. Specifically, there were no strokes reported in the 753 patients treated with apixaban, compared with six strokes in the 747 patients in the warfarin group. Major bleeds occurred in three patients in the apixaban group compared with six in the warfarin group. Clinically relevant non-major bleeding occurred in 11 and 13 patients, respectively. No systemic embolic events were reported in either group. A total of three deaths (two apixaban and one warfarin) were reported. Of the 342 patients in the apixaban group who received a loading dose, there were no strokes or systemic embolic events, one death, one major bleed and four clinically relevant non-major bleeds.
Like the other prospective cardioversion studies, researchers noted that EMANATE was underpowered. However, they said their findings “support the use of apixaban in patients with AFib undergoing cardioversion.”
Keywords: ESC Congress, ESC2017, Warfarin, Atrial Fibrillation, Heparin, Electric Countershock, Creatinine, Pyridones, Pyrazoles, Stroke, Hemorrhage, Embolism
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