Propafenone versus Amiodarone for Supraventricular Arrhythmias in Septic Shock: A Randomised Controlled Trial

Abstract

Abstract Purpose Acute onset supraventricular arrhythmias contribute to haemodynamic compromise in septic shock. Both amiodarone and propafenone are drugs of choice, but their clinical effects have not yet been directly compared. Methods Two-centre, randomised prospective controlled parallel group double blind trial recruited 209 septic shock patients with new-onset arrhythmia and a left ventricular ejection fraction above 35%. The patients were randomly assigned in a 1:1 ratio to receive either intravenous propafenone (70mg bolus followed by 400-840mg/24h) or amiodarone (300mg bolus followed by 600-1800mg/24h). The primary outcomes were the proportion of patients who had sinus rhythm 24 hours after the start of the infusion, time to restoration of the first sinus rhythm and the proportion of patients with arrhythmia recurrence. Results Out of 209 randomized patients, 200(96%) received the study drug. After 24 hours, 77(72.8%) and 71(67.3%) were in sinus rhythm (p = 0.40), restored after a median of 4.3h (95%CI 2.8;7.3) and 7.8h (95%CI 5.9;11), p = 0.03, with propafenone and amiodarone, respectively. The arrhythmia recurred at least once in 54(52%) patients treated with propafenone and in 80(76%) with amiodarone, p˂0.001. Patients with a dilated left atrium had better rhythm control with amiodarone (6.4h (95%CI 3.5;14.1) until cardioversion vs 14.1h (95%CI 2.8;24.7) in propafenone, p = 0.05). Conclusion Propafenone administration in patients with septic shock does not provide better rhythm control at 24 hours yet offers faster cardioversion with fewer arrhythmia recurrences than with amiodarone, especially in patients with a non-dilated left atrium. Both drugs did not differ in their impacts on short- and long-term outcomes. Trial registration: ClinicalTrials.gov Identifier: NCT03029169, registered on 24th of January 2017