Amiodarone and sotalol are equally efficacious in converting atrial fibrillation (AF) to sinus rhythm, according to the results of a randomized trial published in the May 5 issue of the New England Journal of Medicine. However, amiodarone is superior for maintaining sinus rhythm.
“The optimal pharmacologic means to restore and maintain sinus rhythm in patients with atrial fibrillation remains controversial,” write Bramah N. Singh, MD, DSc, from the Department of Veterans Affairs Medical Center in West Los Angeles, California, and colleagues. “The double-blind Sotalol Amiodarone Atrial Fibrillation Efficacy Trial (SAFE-T) compared the ability of sotalol and amiodarone to restore and maintain sinus rhythm in patients with atrial fibrillation.”
In the SAFE-T study, 665 patients who were receiving anticoagulants and had persistent AF were randomized to receive amiodarone (n = 267), sotalol (n = 261), or placebo (n = 137) and were monitored for one to 4.5 years. The main outcome measure was the time to recurrence of AF beginning on day 28, determined by weekly transtelephonic monitoring.
Spontaneous conversion occurred in 27.1% of the amiodarone group, in 24.2% of the sotalol group, and in 0.8% of the placebo group. Direct-current (DC) cardioversion failed in 27.7%, 26.5%, and 32.1%, respectively. On the basis of intent-to-treat (ITT), the median times to recurrence of AF were 487 days for amiodarone, 74 days for sotalol, and six days for placebo. According to treatment received, median times were 809, 209, and 13 days, respectively.
In terms of efficacy, amiodarone was superior to sotalol (P < .001) and to placebo (P < .001), and sotalol was superior to placebo (P < .001). In patients with ischemic heart disease (IHD), the median time to recurrence of AF was 569 days with amiodarone and 428 days with sotalol (P = .53). Restoration and maintenance of sinus rhythm were significantly associated with quality of life (QOL) and exercise capacity. Major adverse events occurred with similar frequency in all three groups.
Study limitations include lack of power to evaluate mortality differences.
“Amiodarone and sotalol are equally efficacious in converting atrial fibrillation to sinus rhythm,” the authors write. “Amiodarone is superior for maintaining sinus rhythm, but both drugs have similar efficacy in patients with ischemic heart disease. Sustained sinus rhythm is associated with an improved quality of life and improved exercise performance.”
The Cooperative Studies Program of the Department of Veterans Affairs Office of Research and Development in Washington, D.C.; Berlex Laboratories, the maker of sotalol; and Wyeth-Ayerst Laboratories, the maker of amiodarone, supported this study.