Abstract

Acute onset supraventricular arrhythmias can contribute to haemodynamic compromise in septic shock. Both amiodarone and propafenone are available interventions, but their clinical effects have not yet been directly compared. In this two-centre, prospective controlled parallel group double blind trial we recruited 209 septic shock patients with new-onset arrhythmia and a left ventricular ejection fraction above 35%. The patients were randomised 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 24h after the start of the infusion, time to restoration of the first sinus rhythm and the proportion of patients with arrhythmia recurrence. Out of 209 randomized patients, 200 (96%) received the study drug. After 24h, 77 (72.8%) and 71 (67.3%) were in sinus rhythm (p = 0.4), restored after a median of 3.7h (95% CI 2.3-6.8) and 7.3h (95% CI 5-11), p = 0.02, with propafenone and amiodarone, respectively. The arrhythmia recurred 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 18h (95% CI 2.8; 24.7) in propafenone, p = 0.05). Propafenone does not provide better rhythm control at 24h yet offers faster cardioversion with fewer arrhythmia recurrences than with amiodarone, especially in patients with a non-dilated left atrium. No differences between propafenone and amiodarone on the prespecified short- and long-term outcomes were observed.

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