Arrhythmias and Conduction Disturbances
Prospective Comparison of Flecainide Versus Sotalol for Immediate Cardioversion of Atrial Fibrillation

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Abstract

This study sought to compare the efficacy and safety of intravenous flecainide and sotalol for immediate cardioversion of atrial fibrillation. We performed a prospective, randomized, single-blind, multicenter trial, including 106 hemodynamically stable patients with atrial fibrillation, stratified according to duration of the arrhythmia. Exclusion criteria included severely reduced left ventricular systolic function, recent antiarrhythmic therapy, and hypokalemia. Patients were randomly assigned to receive either intravenous flecainide or intravenous sotalol. Trial medication was given at a dose of 1.5 mg/kg body weight (maximum 150 mg). Overall, 28 of 54 patients (52%) given flecainide and 12 of 52 patients (23%) given sotalol converted to sinus rhythm during the first 2 hours after start of the infusion (p = 0.003). Multivariate analysis confirmed that treatment allocation to flecainide, an arrhythmia duration of ≤24 hours, higher plasma magnesium level at baseline, higher age for men, and lower age for women independently increases the probability of conversion. The frequency of adverse effects was not significantly different in the 2 treatment groups.

Section snippets

Study patients

Patients were considered possible candidates for entry into the study if there was sustained AF lasting ≥15 minutes to ≤6 months with a ventricular rate ≥80 beats/min at rest. Patients with atrial flutter were not eligible. Exclusion criteria were clinical signs of congestive heart failure (New York Heart Association functional class >II), severely reduced left ventricular systolic function (mean left ventricular fractional shortening <20%), unstable angina pectoris, acute myocardial infarction

Patient characteristics

Altogether, 106 hospitalized patients meeting inclusion and exclusion criteria were enrolled into the trial (Table I). Regarding underlying disease, 31 patients had systemic hypertension (13 with and 18 without left ventricular hypertrophy), 15 had coronary artery disease (11 with prior myocardial infarction), 10 had valvular heart disease, 2 dilated cardiomyopathy, 3 acute pulmonary embolism, 1 chronic pulmonary hypertension, 3 previously undiagnosed hyperthyroidism, 1 sick sinus syndrome

Discussion

This study shows that flecainide is significantly more effective than sotalol for immediate conversion of recent-onset AF.

Acknowledgements

We thank Thomas Quinton, MD, Hans Keller, MD, and the staff of the intensive care units at the participating hospitals for their support and assistance in patient recruitment. We are indebted to Rodney H. Falk, MD, for critical review of the manuscript.

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    This study was supported by research grants from F. Joh. Kwizda GmbH, and Bristol-Myers Squibb GmbH, Vienna, Austria.

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