ENSURE-AF: Edoxaban May Benefit AFib Patients Prior to Cardioversion
Atrial fibrillation (AFib) patients needing anticoagulation prior to cardioversion may benefit from treatment with edoxaban, according to results of the ENSURE-AF study presented Aug. 30 during ESC Congress 2016 in Rome, and published simultaneously in The Lancet.
ENSURE-AF, a phase 3b study involving 239 study sites in 19 countries in Europe and the U.S., included 2,199 patients with documented non-valvular AFib who were scheduled for electrical cardioversion after anticoagulation therapy. A total of 1,095 patients were randomized to receive edoxaban, while the remaining 1,104 received enoxaparin/warfarin (dosing varied depending on patient characteristics).
Of these, 988 patients in the edoxaban group and 966 patients in the enoxaparin/warfarin underwent electrical or spontaneous cardioversion, some with the use of transesophageal echocardiography (TEE).
At 28 days, the primary efficacy objective comparing the incidences of the composite endpoint of stroke, systemic embolic event, myocardial infarction and cardiovascular death occurred at a comparable rate in both groups (0.5 percent of edoxaban patients vs. 1.0 percent of enoxaparin/warfarin patients). The primary safety outcome of a composite endpoint of major and clinically relevant non-major bleeding events at 30 days also occurred at a comparable rate (1.5 percent and 1.0 percent, respectively).
“At a practical level, our study results show that newly diagnosed non-anticoagulated AF patients can start edoxaban as early as two hours prior to their cardioversion procedure if they have access to TEE or three weeks prior without,” said investigator Andreas Goette, MD, St. Vincenz-Hospital, Paderborn, Germany.
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