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Hot Line Session Results
Edoxaban is an effective and safe alternative to anticoagulation therapy for AF patients undergoing electrical cardioversion, according to the ENSURE-AF study presented in a Hot Line yesterday. The findings were published simultaneously in The Lancet.
ENSURE-AF is the largest prospective randomised trial to date of anticoagulation for cardioversion in patients with AF. Principal investigator Andreas Goette said the advantage of this new approach was ‘very convenient and very fast’.
‘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 cardioversion if they have access to transoesophageal echocardiography or three weeks prior to that,’ said Goette, from St Vincenz-Hospital, Paderborn, Germany.
Current guidelines for AF patients having cardioversion recommend three weeks of therapeutic anticoagulation prior to the procedure. This is followed by continuation of anticoagulation for four weeks - or longer in patients at risk of AF recurrence or those with stroke risk factors present.
VKAs have traditionally been used successfully as oral anticoagulants around cardioversion. However, they have major limitations in that VKAs require regular monitoring to ensure target INR range of 2.0-3.0. This can delay cardioversion sometimes for several weeks.
Trials have suggested that NOACs could be a safe alternative to VKAs, but there is limited data on the NOAC endoxaban in this role. ENSURE-AF was thus designed to assess the efficacy and safety of edoxaban when compared to the conventional therapy (enoxaparin/warfarin) in patients with non-valvular AF having cardioversion. It aimed to demonstrate that once-daily edoxaban is a feasible treatment option for patients undergoing cardioversion.
The phase 3b study involved 239 study sites in 19 countries in Europe and the US, with 2199 patients with documented non-valvular AF recruited. All were scheduled for electrical cardioversion after anticoagulation therapy.
A total of 1095 were randomised to edoxaban, and 1104 to enoxaparin/warfarin with dosing varied depending on patient characteristic. A total of 90.2% (n=988) were cardioverted electrically and 87.5% (n=966) were cardioverted spontaneously, some with TEE.
The study’s primary efficacy objective was to compare incidences of the composite endpoint of stroke, MI and CV death between the two groups at day 28 (ITT analysis).
The endpoint occurred at a comparable rate in both groups, that is in 0.5% in the edoxaban arm versus 1.0% in the enoxaparin/warfarin arm (OR=0.46; 95% CI, 0.12-1.43).
The primary safety outcome was a composite endpoint of major and clinically relevant non-major bleeding events at 30 days. This also occurred at a comparable rate of 1.5% and 1.0% respectively.
Overall, edoxaban had similar rates of major bleeding and thromboembolism compared to well-managed optimised enoxaparin/warfarin therapy. Results were also similar whether TEE-guidance was used or not, whether patients had received prior anticoagulation or not, and in patients with a broad range of associated comorbidities.
Professor Goette said: ‘Results suggest that edoxaban is an effective and safe alternative to standard enoxaparin/warfarin VKA therapy.’
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