Comparison of intravenously administered dofetilide versus amiodarone in the acute termination of atrial fibrillation and flutter. A multicentre, randomized, double-blind, placebo-controlled study.

Objective: This study compared the efficacy and safety of intravenous dofetilide with amiodarone and placebo in converting atrial fibrillation or flutter to sinus rhythm.

Results: One hundred and fifty patients with atrial fibrillation or flutter (duration range 2 h-6 months) were given 15-min intravenous infusions of 8 microg. kg(-1)of dofetilide (n=48), 5 mg. kg(-1)of amiodarone (n=50), or placebo (n=52) and monitored continuously for 3 h. Sinus rhythm was restored in 35%, 4%, and 4% of patients, respectively (P<0.001, dofetilide vs placebo;P=ns, amiodarone versus placebo). Dofetilide was more effective in atrial flutter than in atrial fibrillation (cardioversion rates 75% and 22%, respectively;P=0.004). The mean time to conversion with dofetilide was 55+/-15 min. Dofetilide prolonged the QTc interval (+16% at 20 min). Amiodarone substantially decreased the ventricular rate in non-converters (-18 beats. min(-1)at 30 min). Two patients given dofetilide (4%) had non-sustained ventricular tachycardias, and four (8%) had torsade de pointes, in one case requiring electrical cardioversion.

Conclusions: Intravenous dofetilide is significantly more effective than amiodarone or placebo in restoring sinus rhythm in patients with atrial fibrillation or flutter. However, when infused intravenously at this dose and rate, dofetilide causes a significant incidence of torsade de pointes.