Comparing TEE vs non‐TEE guided cardioversion of atrial fibrillation: The ENSURE‐AF trial
European Journal of Clinical Investigation Mar 18, 2020
Kozieł M, Merino JL, De Caterina R, et al. - In ENSURE‐AF (NCT 02072434), therapy with edoxaban vs enoxaparin–warfarin was assessed in patients with nonvalvular atrial fibrillation (AF) undergoing elective electrical cardioversion (ECV). Researchers here assessed patients awaiting ECV of AF with a transesophageal echocardiography (TEE)‐guided vs a non‐TEE guided strategy for 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). In this prospective randomized open‐label blinded endpoint study, randomization of 2,199 patients was done 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. The TEE‐guided strategy was allocated in 589 patients from the edoxaban stratum and 594 from the enoxaparin‐warfarin stratum. Outcomes revealed no differences regarding thromboembolic and bleeding events between patients undergoing TEE‐guided strategy and those undergoing an optimized conventional anticoagulation approach for ECV of AF. TEE use was observed in independent correlation with following factors: history of ischaemic stroke/ transient ischaemic attack, hypertension and valvular heart disease. Independent predictors of the efficacy endpoint were mean CHA2DS2VASc and HAS‐BLED score whilst mean age was an independent predictor of the safety endpoint.
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