TY - JOUR 
A1 - Lip, Gregory Y. H.
AU - Merino Llorens, José Luis
AU - Banach, Maciej
AU - Al‐Saady, Naab
AU - Jin, James
AU - Melino, Michael
AU - Winters, Shannon M.
AU - Kozieł, Monika
AU - Goette, Andreas
T1 - Clinical factors related to successful or unsuccessful cardioversion in the EdoxabaN versus warfarin in subjectS UndeRgoing cardiovErsion of Atrial Fibrillation (ENSURE‐AF) randomized trial
Y1 - 2020
SN - 1883-2148
UR - http://hdl.handle.net/11268/8920
AB - Background
EdoxabaN versus warfarin in subjectS UndeRgoing cardiovErsion of Atrial Fibrillation evaluated use of nonvitamin K antagonist oral anticoagulant edoxaban vs enoxaparin‐warfarin in patients with nonvalvular atrial fibrillation undergoing electrical cardioversion.

Hypothesis
To assess clinical factors related to successful or unsuccessful cardioversion. To evaluate whether differences in adverse events based on anticoagulation strategy may exist.

Methods
In this multicenter prospective randomized open‐label blinded end‐point evaluation trial, 2199 patients were randomized 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. Successful cardioversion was confirmed by 12‐lead electrocardiography‐documented sinus rhythm.

Results
Cardioversion was successful in 1578 patients; in 355 patients, cardioversion was unsuccessful. Male, high body weight, high body mass index (BMI), coronary artery disease, concomitant aspirin, or prior statins use were more common in patients with unsuccessful cardioversion; international normalized ratio control did not differ by cardioversion success. On multivariate analysis, gender (P < .05), body weight (P = .0196) and BMI (P = .0377) emerged as independent predictors of successful cardioversion. There were no significant differences in primary efficacy (a composite of stroke, systemic embolic event, myocardial infarction, and cardiovascular death during overall study period) regardless of cardioversion success. There were no significant differences in bleeding rates, regardless of cardioversion outcome; notwithstanding low numbers, edoxaban and enoxaparin‐warfarin did not differ.
KW - Enfermos cardíacos
KW - Medicamentos cardiovasculares
KW - Enfermedad cardiovascular
KW - Medicamento
LA - eng
ER -