The Drug And Pace Health cliNical Evaluation (DAPHNE) study: a randomized trial comparing sotalol versus beta-blockers to treat symptomatic atrial fibrillation in patients with brady-tachycardia syndrome implanted with an antitachycardia pacemaker.

BACKGROUND

Atrial tachyarrhythmias (ATAs) are mainly treated by pharmacologic therapy for rate control or rhythm control. The aim of our study was to compare sotalol (S) versus beta-blocking agents (BB) in terms of prevention of ATA, cardioversions (CVs), and cardiovascular hospitalizations (H) in patients paced for bradycardia-tachycardia form of sinus node disease (BT-SND).

METHODS

One hundred thirty-five patients (67 males, aged 73 +/- 7 years) were enrolled in a prospective, parallel, randomized, single-blind, multicenter study. All patients received a dual chamber rate adaptive pacemaker; after 1 month, 66 patients were randomly assigned to BB (62 +/- 26 and 104 +/- 47 mg/d for atenolol and metoprolol, respectively) and 69 patients to S (167 +/- 66 mg/d).

RESULTS

After an observation period of 12 months, the percentage of patients free from ATA recurrences was 29% in both BB and S group. Cardioversion and H were significantly (P < .01) fewer in the 12 months after implantation than in the 12 months before both in patients treated with S (CV 69.4% vs 22.2%, H 91.7% vs 33.3%) and in patients treated with BB (CV 58.5% vs 17.1%, H 82.9% vs 26.8%). Kaplan-Meier survival analysis showed a nonsignificant trend toward a lower incidence of the composite end point (CV + H) among BB patients.

CONCLUSIONS

In the complex context of "hybrid therapy" in patients with BT-SND implanted with a modern dual chamber rate adaptive pacemaker device delivering atrial antitachycardia pacing, no differences were found between the use of beta-blocker and the use of S, at the relatively low dose achieved after clinical titration, in terms of prevention of cardiovascular H or need for atrial CV.