Abstract
PurposeThe purpose of the present study was to compare the long-term effectiveness and safety of newly initiated anticoagulation with edoxaban (EDO) versus uninterrupted vitamin K antagonist (VKA) therapy in patients with atrial fibrillation (AF) scheduled for transesophageal echocardiogram (TEE)-guided direct electrical current cardioversion (DCC).MethodsA propensity score-matched cohort observational study was performed comparing the safety and effectiveness of edoxaban versus well-controlled VKA therapy among a cohort of consecutive non-valvular AF patients scheduled for DCC. The primary safety outcome was major bleeding. The primary efficacy outcome was the composite of stroke, transient ischemic attack (TIA), and systemic embolism (SE).FindingsA total of 130 AF patients receiving edoxaban 60-mg (EDO) treatment were compared with the same number of VKA recipients. The cumulative incidence of major bleedings was 1.54% in the EDO group and 3.08% in the VKA group (P = 0.4). The cumulative incidence of thromboembolic events was 1.54% in the EDO group and 2.31% in the VKA group (P = 0.9). A non-significant trend in improved adherence was observed between the EDO and VKA groups with a total anticoagulant therapy discontinuation rate of 4.62% (6/130) vs 6.15% (8/130), respectively (P = 0.06).ImplicationsOur study provides the evidence of a safe and effective use of edoxaban in this clinical setting, justified by no significant difference in major bleedings and thromboembolic events between edoxaban and well-controlled VKA treatments.
Highlights
Cardioversion in atrial fibrillation (AF) patients is associated with an increased risk of thromboembolic events [1, 2] and an adequate level of periprocedural anticoagulation is essential to reduce this risk
We identified 495 consecutive patients with persistent AF scheduled for transesophageal echocardiogram (TEE)-guided direct current cardioversion (DCC) during the time period from January 2017 to January 2019 who received edoxaban (n = 230) or vitamin K antagonist (VKA) treatment (n = 210)
Propensity score matching identified 130 edoxaban and the same number of VKA recipients scheduled for DCC who were comparable with respect to demographic and clinical characteristics
Summary
Cardioversion (both electric and pharmacological) in AF patients is associated with an increased risk of thromboembolic events [1, 2] and an adequate level of periprocedural anticoagulation is essential to reduce this risk. Federico II, Naples, Italy increasing [3,4,5,6,7,8,9], even in the setting of patients with AF undergoing electrical cardioversion [10,11,12,13], and the current guidelines recommend initiating anticoagulation with DOACs as soon as possible before every cardioversion of AF [14, 15]. Edoxaban (EDO), a direct oral factor Xa inhibitor, was demonstrated to be non-inferior to enoxaparin-warfarin therapy in terms of composite net clinical benefit outcome of stroke, systemic embolic event, transient ischemic attack, myocardial infarction, cardiovascular mortality, and major bleeding events in patients undergoing cardioversion of atrial fibrillation [16]. The aim of the present study was to investigate the safety and effectiveness of newly initiated
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