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Oral Propafenone To Convert Recent-Onset Atrial Fibrillation in Patients with and without Underlying Heart Disease: A Randomized, Controlled Trial

Giuseppe Boriani, MD; Mauro Biffi, MD; Alessandro Capucci, MD; Gian Luca Botto, MD; Tiziana Broffoni, MD; Ida Rubino, MD; Stefano Della Casa, MD; Mario Sanguinetti, MD; and Bruno Magnani, MD
[+] Article and Author Information

From Universita degli Studi di Bologna, Bologna, Italy; Ospedale Civile di Piacenza, Piacenza, Italy; Ospedale S. Anna, Como, Como, Italy; and Presidio Ospedaliero di Lugo, Lugo, Italy. Acknowledgment: The authors thank Antonio Mininno (Clinical Engineering, St. Jude Medical, Italy) for assistance with data analysis. Requests for Reprints: Giuseppe Boriani, MD, Istituto di Cardiologia, Universita degli Studi di Bologna, Via Massarenti 9, 40138 Bologna, Italy. Current Author Addresses: Drs. Boriani, Biffi, and Magnani: Istituto di Cardiologia, Universita degli Studi di Bologna, Via Massarenti 9, 40138 Bologna, Italy.


Copyright ©2004 by the American College of Physicians


Ann Intern Med. 1997;126(8):621-625. doi:10.7326/0003-4819-126-8-199704150-00006
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Background: The effectiveness of oral propafenone in converting recent-onset atrial fibrillation to sinus rhythm has been established by controlled trials. However, it is not clear whether the effectiveness of propafenone is affected by the presence or absence of underlying heart disease.

Objectives: To investigate the safety and effectiveness of oral propafenone and the role of underlying heart disease.

Design: Randomized, single-blind, controlled study.

Setting: 3 teaching hospitals.

Patients: 240 hospitalized patients with recent-onset atrial fibrillation.

Intervention: Propafenone (one 600-mg oral dose) or placebo.

Measurements: Conversion rates at 3 and 8 hours.

Results: Propafenone was more effective than placebo for converting atrial fibrillation to sinus rhythm at 3 hours: Fifty-four of 119 patients (45%) receiving propafenone and 22 of 121 patients (18%) receiving placebo had conversion (P < 0.001). It was also more effective at 8 hours: Ninety-one of 119 patients (76%) receiving propafenone and 45 of 121 patients (37%) receiving placebo had conversion (P < 0.001). Subgroup analysis showed that among patients without heart disease, 78% of those receiving propafenone and 56% of those receiving placebo converted to sinus rhythm within 8 hours (P = 0.02). In those with hypertension, the rate was 70% for those receiving propafenone and 27% for those receiving placebo (P < 0.001); in patients with structural heart disease, the rate was 81% for those receiving propafenone and 17% for those receiving placebo (P < 0.001).

Conclusions: Oral loading of propafenone was more effective than placebo for conversion to sinus rhythm within 8 hours and had a favorable safety profile. The rate of spontaneous conversion to sinus rhythm was higher in patients without structural heart disease; this finding has important implications for the assessment of drug effectiveness in recent-onset atrial fibrillation.

Figures

Grahic Jump Location
Figure 1.
Conversion to sinus rhythm within 8 hours in patients receiving propafenone or placebo.

Rates are shown for the whole population and for three subgroups: patients without heart disease, patients with hypertension, and patients with heart disease.

Grahic Jump Location

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