Comparing TEE‐ vs non–TEE‐guided cardioversion of atrial fibrillation: The ENSURE‐AF trial
European Journal of Clinical Investigation Apr 03, 2020
Kozieł M, Merino JL, De Caterina R, et al. - In ENSURE‐AF (NCT 02072434), assessment of therapy with edoxaban vs enoxaparin‐warfarin was performed in patients with nonvalvular atrial fibrillation (AF) undergoing elective electrical cardioversion (ECV). Researchers here examined patients awaiting ECV of AF with a transesophageal echocardiography (TEE)‐guided vs a non–TEE‐guided strategy for their clinical features and primary efficacy (composite of stroke, systemic embolic events, myocardial infarction and cardiovascular mortality during study period) and safety endpoints (composite of major and clinically relevant nonmajor bleeding during on‐treatment period). Randomization of 2,199 patients to edoxaban 60 mg once‐daily (30 mg for creatinine clearance 15‐50 mL/min, weight ≤ 60 kg and/or concomitant use of P‐glycoprotein inhibitor) or enoxaparin‐warfarin was done in this prospective, randomized, open‐label, blinded endpoint study. The TEE‐guided strategy was applied to a total of 589 patients from the edoxaban stratum and 594 from the enoxaparin‐warfarin stratum. TEE use was observed in independent correlation with history of ischaemic stroke/ transient ischaemic attack, hypertension and valvular heart disease. Outcomes revealed no differences in thromboembolic and bleeding events between patients undergoing TEE‐guided strategy and in those undergoing an optimized conventional anticoagulation approach for ECV of AF. They identified independent predictive value of mean CHA2DS2VASc and HAS‐BLED score for the efficacy endpoint whilst mean age was identified to be an independent predictor of the safety endpoint.
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