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
In brief
Flecainide restored rhythm in 86% of patients with coronary disease
In this randomized trial of 87 patients with paroxysmal atrial fibrillation and coronary artery disease without active or residual ischemia, intravenous flecainide restored normal rhythm within 6 hours in 86%, compared with 40% receiving amiodarone. Conversion was faster and fewer patients were admitted, but the small trial cannot establish safety beyond its short follow-up; no serious ventricular rhythm events occurred within 24 hours.
- Journal
- Heart rhythm (Q1)
- Published
- 6 October 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Panagiotis-Anastasios Tsioufis, Dimitrios Tsiachris, Nikos Argyriou, Michail Botis, Ioannis Doundoulakis, Athanasios Kordalis, et al.
- PMID
- 42838320
- DOI
- 10.1016/j.hrthm.2026.09.051
Why clinicians should know about it
- Picked for Emergency Medicine (paper of the day, 7 October 2026): Flecainide vs amiodarone for acute cardioversion
Abstract
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.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.