Propafenone Treatment of Symptomatic Paroxysmal Atrial Fibrillation. A Randomized, Placebo-Controlled Trial in Patients With Oral Therapy.

Pozzer Domingo Luis; Fernandez Eva; Farias Eduardo

Abstract
Introduction: The maintenance of sinus rhythm in patients with recurrent paroxysmal atrial fibrilation (RPAF) is frequently hard, this situation is generated by the low effectiveness of antiarrythmic drugs.
Objectives: To evaluate if propafenone administered orally is effective and safe in prevent recurrent atrial fibrillation we conduct a randomized double blind clinical trial.
Methods: Patients with history of paroxystic atrial fibrillation successfully treated and actually with normal sinus rhythm without any other antiarrhythmic drug and left ventricular shortening fraction over 30 % were assigned to receive or placebo or 300 mg twice daily of propafenone, over a six month period. Exclusion criteria were recent myocardial infarction, severe heart failure, New York Heart functional class over III, severe conduction disorders in the EKG, systolic blood pressure less than 90 mm Hg.
Results: Thirty-six patients, 16 men and 20 women, (range of ages: 33 to 80 years) were included. The two groups were comparable with respect to baseline characteristics. Its etiology was related to hypertensive heart disease (39%), valvular heart disease (5%), or idiopathic (55.5%). The arrhythmia was symptomatic in all patients on inclusion.
At the end of follow up only 1 patients of the oral propafenone group (6.25 % CI 95 % 0.1–30%) and 4 of the placebo group (25% CI 95 % 7.2–52.4 %) suffered arrhythmic recurrence (p= 0.33). During the same period 1 patients in the placebo group dead of non-cardiovascular cause.
Discussion: The number of patients included in this study do not permit takes definitively conclusions, but there were less number of recurrences in the propafenone group, but this difference not reach statistically significance (6.25 % vs. 25 % p=0.3). The tolerance of the drug was good. The main limitation of this study was the low number of patients included, however propafenone seem to be effective and safe to prevent RPAF.
Conclusions: Oral propafenone seems to be effective and safe in reducing symptomatic paroxysmal atrial fibrillation.

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