Preliminary results of a prospective randomized study comparing the efficacy and safety of refralon and amiodarone in cardioversion in patients with paroxysmal atrial fibrillation and flutter

Aim . To compare the efficacy and safety of chemical cardioversion (CCV) with refralon and amiodarone in patients with paroxysmal atrial fibril­lation and flutter (AF/AFL). Material and methods . Fifty five patients (mean age, 65±11 years) with paroxysmal AF/AFL were included. All patients underwent a preliminary examination to rule out contraindications to CCV. Further, patients were randomized into groups of refralon (n=30) and amiodarone (n=28), respectively. CCV with refralon was carried out as follows: administration in doses of 5-5-10-10 µg/kg at intervals of 15 minutes. Patients of the second group were intravenously injected with amiodarone at a dose of 5 mg/kg of body weight for 20-60 minutes, depending on the drug tolerability. If AF/AFL persists after 60 minutes, infusion of amio­darone 100 mg/hour until restoration of sinus rhythm (SR) or reaching a dose of 1200 mg/day. Treatment efficacy was assessed by SR reco­very, absence of AF/AFL recurrence, and arrhythmia relief time, and safety was assessed by detection of ventricular arrhythmogenic effects, bradyarrhythmias, blood pressure reduction, and QT interval prolongation. The follow-up period lasted 24 hours. Results . SR was restored in 96,7% (n=29) of patients in the refralon group, of which 56,7% (n=17) after a dose of 5 mcg/kg. In the amio­darone group, SR was restored in 57,1% (n=16) of patients (p