Sotalol versus propafenone for long-term maintenance of normal sinus rhythm - Sotalol versus propafenone for long-term maintenance of normal sinus rhythm
The goal of the trial was to evaluate treatment with sotalol versus propafenone for long-term maintenance of normal sinus rhythm in patients with recurrent symptomatic atrial fibrillation (AF).
Patients Enrolled: 254
Mean Follow Up: Up to 48 months
Mean Patient Age: Mean age 63 years
Age >18 years; electrocardiographic documentation of AF; symptoms such as light-headedness, palpitation, chest pain, and dyspnea in association with AF; and successful chemical or electrical cardioversion to sinus rhythm in patients who had chronic AF
Acute myocardial infarction <7 days before entry into the trial; cardiogenic shock; transient AF related to an ongoing process, such as pneumonia, pulmonary embolism, recent cardiac surgery, or uncontrolled congestive heart failure; unstable hepatic or renal function; echocardiographic ejection fraction <40%; hyperthyroidism; other major medical syndromes in which the patient had a life expectancy of <1 year; and previous unsuccessful treatment with sotalol, propafenone, or amiodarone
After restoration of sinus rhythm, patients were randomized to sotalol (80 mg twice daily initially, titrated upward to 480 mg daily; n=85), propafenone (150-300 mg orally initially, followed by 150 mg three times per day maintenance dose; n=86), or placebo (three tablets per day; n=83).
Baseline characteristics were similar between the three groups. The mean number of months since AF diagnosis was eight months in the sotalol group, nine months in the propafenone group, and eight months in the placebo group. Baseline ejection fraction was 52%, 54%, and 53%, respectively.
AF relapse or side effects were reported in 69 of the 85 patients in the sotalol group after a mean period of 18 months, which was a higher rate and a short time to event compared with the propafenone group (45 of 86 patients had an event after mean period of 26 months; p<0.001). The highest rate and the shortest time to event was in the placebo group (73 of 83 patients had an event after a mean period of 11 months; p<0.001 vs. sotalol and vs. propafenone). The study drug was discontinued due to significant side effects in 5 of the 69 patients who received sotalol and 5 of the 45 patients who received propafenone.
Among patients with recurrent symptomatic AF, long-term treatment with propafenone was associated with a reduction in AF relapse and side effects compared with both sotalol and placebo, while sotalol was associated with a reduction in AF relapse and side effects compared with placebo. The Kaplan-Meier event rate curves for the frequency of AF relapse or side effects began to diverge in the propafenone group after six months and continued through follow-up, suggesting benefit throughout the long-term treatment.
Kochiadakis GE, Igoumenidis NE, Hamilos ME, et al. Sotalol versus propafenone for long-term maintenance of normal sinus rhythm in patients with recurrent symptomatic atrial fibrillation. Am J Cardiol 2004;94:1563–6.
Keywords: Follow-Up Studies, Dizziness, Chest Pain, Heart Conduction System, Electric Countershock, Propafenone, Sotalol, Electrocardiography, Dyspnea
< Back to Listings