Intravenous propafenone in paroxysmal atrial fibrillation: a randomized, placebo-controlled, double-blind, multicenter clinical trial. Paroxysmal Atrial Fibrillation Italian Trial (PAFIT)-2 Investigators

Clin Cardiol. 1996 May;19(5):409-12. doi: 10.1002/clc.4960190515.

Abstract

Background: Pharmacological conversion of paroxysmal atrial fibrillation is frequently necessary. The aim of this study was to compare intravenous propafenone, a class Ic antiarrhythmic agent, with placebo in paroxysmal atrial fibrillation (AF) of recent onset (< 72 h).

Patients and methods: We randomly allocated 75 patients, aged 18 to 70 years, with paroxysmal AF to receive intravenous propafenone (2 mg/kg in 15 min followed by 1 mg/kg in 2 h) or the matching placebo. Patients were followed for 3 h. Exclusion criteria were the presence of one of the following: clinical heart failure, recent acute myocardial infarction, hypotension, atrioventricular block, Wolff-Parkinson-White syndrome, or current treatment with antiarrhythmic agents or digitalis.

Results: No sign of heart disease was found in 74.7% of the patients. Echocardiographically determined left atrium diameter was similar in the two groups. Conversion to sinus rhythm occurred in 24 of 41 patients allocated to propafenone and in 10 of 34 patients allocated to placebo (odds ratio 3.2, 95% confidence intervals 1.3-7.9; p < 0.01). Mean conversion time was 34 +/- 29 and 71 +/- 55 min, respectively, for propafenone and placebo. Mean heart rate in nonconverters decreased from 146 to 109 beats/min in patients treated with propafenone while it remained virtually unchanged in those treated with placebo. Only minor side effects were noted.

Conclusions: Intravenous propafenone is an effective therapeutic option for restoring sinus rhythm in patients with paroxysmal AF of recent onset.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Anti-Arrhythmia Agents / administration & dosage
  • Anti-Arrhythmia Agents / adverse effects
  • Anti-Arrhythmia Agents / therapeutic use*
  • Atrial Fibrillation / diagnostic imaging
  • Atrial Fibrillation / drug therapy*
  • Atrial Fibrillation / physiopathology
  • Double-Blind Method
  • Echocardiography
  • Electrocardiography
  • Female
  • Heart Rate / drug effects
  • Humans
  • Infusions, Intravenous
  • Male
  • Middle Aged
  • Propafenone / administration & dosage
  • Propafenone / adverse effects
  • Propafenone / therapeutic use*
  • Ventricular Dysfunction, Left / diagnostic imaging
  • Ventricular Dysfunction, Left / drug therapy*
  • Ventricular Dysfunction, Left / physiopathology

Substances

  • Anti-Arrhythmia Agents
  • Propafenone