Efficacy and Safety of Flecainide Versus Amiodarone for the Cardioversion of paroxysmal Atrial Fibrillation in Patients with Coronary Artery Disease without evidence of residual ischemia: The FLECA-ED Randomized Clinical Trial

BACKGROUND: Flecainide has been contraindicated in patients with coronary artery disease (CAD) since the Cardiac Arrhythmia Suppression Trial. OBJECTIVE: We compared intravenous flecainide with intravenous amiodarone for cardioversion of recent-onset paroxysmal atrial fibrillation (AF) in patients with documented CAD without residual or active ischemia presenting to the emergency department. METHODS: In this investigator-initiated, multicenter, open-label, randomized trial, adults with paroxysmal AF and CAD without residual or active ischemia were assigned 1:1 to intravenous flecainide or amiodarone. All patients underwent 24-hour ambulatory ECG monitoring. The primary efficacy end point was conversion to sinus rhythm within 6 hours. The primary safety end point was the composite of nonsustained ventricular tachycardia, ventricular tachycardia, premature ventricular complexes, significant hypotension, and bradycardia below 50 bpm within 6 hours. RESULTS: Eighty-seven patients underwent randomization (42 flecainide, 45 amiodarone). Conversion to sinus rhythm within 6 hours occurred in 85.7% of patients in the flecainide group and 40.0% in the amiodarone group (P<0.001). Median time to conversion was 20 minutes versus 244 minutes (P<0.001), and hospital admission occurred in 14.3% versus 60.0%, respectively (P<0.001). No ventricular proarrhythmic events occurred within 24 hours in either group and no deaths were recorded through 30 days. CONCLUSION: In patients with paroxysmal AF and CAD without evidence of residual and active ischemia, intravenous flecainide was superior to amiodarone for acute cardioversion, with faster conversion to sinus rhythm and fewer hospital admissions. No serious ventricular proarrhythmia through 24 hours was observed, a hypothesis-generating finding.