Flecainide vs Amiodarone for the cardioversion of Atrial Fibrillation in the Emergency Department in patients with Coronary Artery Disease and preserved ejection fraction. FLECA-ED study

Abstract Background The increasing rates of AF-related ED visits and admissions underscore the need for efficient strategies to safely restore sinus rhythm [1,2]. Amiodarone remains the preferred choice for patients with coronary artery disease (CAD) due to its established safety profile. However, flecainide’s efficacy and safety in CAD patients is an area warranting further exploration, as recent analyses seem to suggest [3,4]. Purpose The primary objectives are to prove the superiority of flecainide over amiodarone in the successful cardioversion of PAF within 6 hours and to demonstrate that the safety of flecainide is non-inferior to amiodarone in patients with CAD without residual ischemia and an EF > 35%. The secondary goals of the study are to prove the superiority of flecainide over amiodarone in the reduction in hospitalizations from the ED, in the time taken to achieve cardioversion, and in the reduction in electrical cardioversion incidence. Methods The FLECA-ED trial (NCT05549752) is a randomized, controlled, multi-center study, enrolling patients with paroxysmal AF, CAD without residual ischemia and EF >35% based on with recent PCI/CABG and/or negative cardiac stress imaging. Continuous ECG monitoring is employed directly before randomization to IV flecainide or amiodarone for 24 hours post-administration, with 30-day follow-up. Study endpoints include SR restoration within 6 hours, time to cardioversion, and incidence of adverse events. Results To date, a total of 25 patients have been enrolled; 10 in the flecainide group and 15 in the amiodarone group. Initial analysis indicates that median time to cardioversion was 35 minutes (IQR 30.8) in the flecainide group and 679 minutes (IQR 1000) in the amiodarone group, p < 0.001. Ten out of 10 patients (100%) receiving flecainide were discharged safely from the ED in SR within 6 hours. 11 out of 15 (73%) patients who received amiodarone required hospitalization. One significant adverse event was reported in the amiodarone group which required hospitalization prolongation with the patient making full recovery. Conclusions Preliminary data from the FLECA-ED study suggest that flecainide may provide a faster and effective alternative to amiodarone for pharmacologic cardioversion in CAD patients with preserved EF. If these trends are confirmed, flecainide could represent a valuable option for enhancing ED efficiency and potentially reducing hospitalization rates.