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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.

Author(s): Capucci A, Botto G, Molon G, Spampinato A, Favale S, Proclemer A, Porfilio A, Marotta T, Vimercati M, Boriani G, DAPHNE Study Investigators

Affiliation(s): Cardiology Department, Civile Hospital, Piacenza, Italy. progettovita@hotmail.com

Publication date & source: 2008-08, Am Heart J., 156(2):373.e1-8. Epub 2008 Jun 9.

Publication type: Comparative Study; Multicenter Study; Randomized Controlled Trial

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.

Page last updated: 2008-08-10

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