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Randomized, Crossover, Controlled Comparison of Oral Loading Versus Intravenous Infusion of Propafenone in Recent‐Onset Atrial Fibrillation

A population of 123 patients witb recent‐onset (< 72 hours) atrial fibrillation (AF) without heart failure was randomly treated witb propafenone (PFN) intravenously (IV) (2 mg/kg bolus followed by 0.0078 mg/kg/min infusion) or in a single oral dose (os) (600 mg), or with placebo (PLA) (phase 1). If AF persisted 8 hours later, patients on active drugs received the alternative formulation (crossover), and patients receiving PLA remained on PLA (phase 2). A 24‐hour Holter monitoring was performed and conversion to sinus rhythm (SR) at 1,4, and 8 hours of each phase was used as the criterion of efficacy. Conversion to SR occurred within 1 hour in 48% of patients witb IV‐PFN, 15 % witb os‐PFN, and in 17% with PLA (both P<0.05 vs IV‐PFN). Oral PFN was superior to PLA at 4 hours (71 % vs 33%, P = 0.001) and 8 hours (78% vs 48%, P < 0.01), and 1 at 8 hours also superior to IV‐PFN (53%, P < 0.03). The mean conversion time within 4 hours was shorter with IV‐PFN (25 ± 15′) than with os‐PFN (167 ± 166, P < 0.001) or with PLA (156 ±107′, P < 0.001). The rates of conversion to SR with IV‐PFN after os‐PFN failure were comparable to PLA at any observation time, whereas nonresponders to IV‐PFN who received os‐PFN had significantly higher conversion rates than with placebo at both 4 hours (65% vs 19%) and 8 hours (76% vs 24%; both P < 0.045). Neither serious adverse effects nor episodes of regular tachycardia with 1:1 AV conduction were noted. PFN administered intravenously or in a single oral loading dose was safe and efficacious in converting recent‐onset AF to SR. The rates of conversion were different with different routes of administration: IV‐PFN was superior to os‐PFN over a short observation period, while the overall efficacy of os‐PFN was superior at 8 hours.