Research in context
Evidence before this study
Post-hoc studies of cardioversion, although limited because of lengthy anticoagulation before the cardioversion, have shown a good safety profile for non-vitamin K antagonist oral anticoagulants (NOACs). One prospective study evaluating rivaroxaban against non-optimised vitamin K antagonist management suggested a good safety profile of this agent. All of these studies are limited by small numbers. Data about the use of NOACs for peri-cardioversion have been provided by post-hoc subgroup analyses from large phase 3 stroke prevention trials and one randomised trial. There are limited data with edoxaban in the setting of electrical cardioversion of non-valvular atrial fibrillation.
Added value of this study
The ENSURE-AF study is the largest randomised clinical trial of anticoagulation for cardioversion in patients with atrial fibrillation, with findings showing very low event rates against exceptionally well controlled warfarin. This trial also provides the largest prospective trial data for an NOAC (ie, edoxaban) in this clinical setting. Edoxaban was also compared against optimised standard care (warfarin with enoxaparin bridging), with the time in the therapeutic range on warfarin being more than 70%, and excellent adherence to edoxaban therapy with more than 99% compliance.
Implications of all the available evidence
The NOACs seem to be safe and user friendly, and provide rapid onset of oral anticoagulation; they provide an alternative to heparin plus warfarin.