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Clinical Articles, Lead Article

ENSURE AF: edoxaban allows prompt cardioversion in AF

Patients with atrial fibrillation (AF) who need anticoagulation before undergoing cardioversion may benefit from treatment with the non-vitamin K antagonist oral anticoagulant (NOAC), edoxaban, compared to best possible conventional therapy (warfarin and enoxaparin), according to results from the ENSURE-AF study presented during a hotline session at the meeting.

The study also showed 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 transoesophageal echocardiography (TEE) or three weeks prior to the procedure without.

ENSURE-AF (Edoxaban versus Enoxaparin/Warfarin in Subjects Undergoing Cardioversion of Atrial Fibrillation), the largest randomised clinical trial of anticoagulation for cardioversion in AF patients, involved 239 study sites in 19 countries in Europe and the US, and included 2,199 patients with non-valvular AF.

At the discretion of the physician, patients either received delayed cardioversion  (non-guided TEE stratum) or early cardioversion (TEE stratum).  They were then randomised equally into two anticoagulation treatments groups per stratum receiving either edoxaban (60/30 mg once daily) or enoxaparin and warfarin (INR 2.0–3.0).  Some 1,095 patients were randomised to receive edoxaban and the remaining 1,104 received enoxaparin/warfarin.

Primary efficacy outcomes (a composite of stroke, systolic embolic event, myocardial infarction and cardiovascular death) were not significant being reached in 0.5% patients (n=5) in the edoxaban arm versus 1.0% (n=11) in the enoxaparin and warfarin arm.

Safety outcomes showed no increased risk of major or clinically relevant non-major bleeding, which were similarly low between the two arms.

Net clinical outcome showed a trend to better outcome in the edoxaban arm but this was not significant.

The study presenter Dr Andreas Goette (St Vincenz Hospital, Paderborn, Germany) said while conventional anticoagulation works well, it has a major limitation in that it requires regular monitoring and dose adjustment to ensure that patients reach anticoagulation targets, which means cardioversion can sometimes be delayed for several weeks.

“Edoxaban,” he continued “may allow prompt cardioversion to be performed following the start of anticoagulation.”

Discussant of the study at the hotline session, Dr Riccardo Cappato (Policlinico San Donato, Milan, Italy) said: “Edoxaban administered at the maximally tolerated single daily dose in the peri-procedural phase of elective AF cardioversion can be considered a safe and effective alternative to VKA therapy”.

The study was simulataneously published in The Lancet (doi: 10.1016/S0140-6736(16)31474-X) on August 30th 2016.

Published on: October 19, 2016

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  • ArrhythmiaAlliance
  • Stars
  • Anticoagulation Europe
  • Atrial Fibrillation Association

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