Differences in Thromboembolic Complications Between Paroxysmal and Persistent Atrial Fibrillation Patients Following Electrical Cardioversion (From the ENSURE-AF Study).

It is unclear if patients with paroxysmal atrial fibrillation (AF) and persistent AF have different outcomes following electrical cardioversion (ECV). ENSURE-AF-a multicenter, prospective, randomized, open-label, blinded-endpoint evaluation trial-compared once-daily edoxaban 60 mg with enoxaparin-warfarin in 2,199 subjects undergoing ECV of nonvalvular AF (NCT02072434). Patients received ≥3 weeks of proper anticoagulation or transesophageal echocardiogram before ECV paroxysmal AF was defined as AF with spontaneous conversion of duration of <7 days; persistent AF was defined as AF lasting ≥7 days without spontaneous conversion. Clinical characteristics and outcomes were compared between subjects based on type of AF present at baseline. In total, 415 subjects had paroxysmal AF; 1,777 had persistent AF. Patients with paroxysmal AF were older (65.8 ± 10.3 vs 63.9 ± 10.5, p = 0.001) with more hypertension (82.7% vs 77.2%, p = 0.01) versus persistent AF patients. Congestive heart failure was more common in persistent AF (46.7%) versus paroxysmal AF (31.3%, p <0.0001). CHA2DS2-VASc (score >2: 52.0% vs 49.5%, p = 0.4375) and prior myocardial infarction (6.5% vs 6.8%, p = 0.91) did not significantly differ between groups. After ECV, primary endpoint events were numerically higher in paroxysmal AF versus persistent AF (1.5% vs 0.6%, p = 0.0571), approaching statistical significance. Of note, myocardial infarction was observed in paroxysmal AF (n = 4 vs 0), whereas persistent AF was accompanied by stroke (n = 0 vs 5; p <0.05). In conclusion, patients with paroxysmal AF had more frequent major cardiovascular events than patients with persistent AF. Composite event rates were driven mainly by myocardial infarction in patients with paroxysmal AF and by stroke in those with persistent AF. Overall, the absolute number of events was low after ECV under anticoagulation.

Determinants of left atrium thrombi in scheduled cardioversion: an ENSURE-AF study analysis.

AIMS: ENSURE-AF (NCT02072434) was the largest prospective randomized clinical trial of anticoagulation for cardioversion in atrial fibrillation (AF), which also provides the largest prospective dataset for transoesophageal echocardiography (TOE) prior to cardioversion. This ancillary analysis investigated determinants of TOE-detected left atrium thrombi (LAT) in patients scheduled for electrical cardioversion (ECV). METHODS AND RESULTS: The ENSURE-AF multicentre PROBE evaluation trial compared edoxaban 60 mg once daily (QD) with enoxaparin/warfarin in 2199 subjects undergoing ECV of non-valvular AF. Patients were stratified by the use of TOE, anticoagulant experience, and selected edoxaban dose. Electrical cardioversion was cancelled or deferred when TOEdetected LAT. In total, 1183 subjects were stratified to the TOE arm and LAT was reported in 91 (8.2%). In univariate analysis, age ≥75 years (26.4% vs. 16.9%, P = 0.0308), lower weight (86.5 ± 15.0 vs. 90.7 ± 18.0 kg, P = 0.0309), lower creatinine clearance (80.1 ± 30.6 vs. 93.2 ± 33.9 mL/min, P = 0.0007), heart failure (59.3% vs. 43.0%, P = 0.0029), and diuretic treatment (53.9% vs. 40.1%, P = 0.0141) were more prevalent in the LAT group. Non-significant trends were seen for higher mean CHA2DS2-VASc score (3.0 ± 1.41 vs. 2.7 ± 1.48, P = 0.0571) and more prevalent anticoagulation use prior to enrolment (60.4% vs. 50.3%, P = 0.0795) in the LAT group. In logistic regression analysis, age (P = 0.0202) and heart failure (P = 0.0064) were independently associated with LAT. CONCLUSION: Elective ECV is commonly cancelled or deferred due to TOE-detected LAT in patients with non-valvular AF. Age ≥75 years and heart failure were associated with the presence of LAT.