The Drug And Pace Health cliNical Evaluation (DAPHNE) study: A randomized trial comparing sotalol versus β-blockers to treat symptomatic atrial fibrillation in patients with brady-tachycardia syndrome implanted with an antitachycardia pacemaker Alessandro Capucci, MD, a GianLuca Botto, MD, b Giulio Molon, MD, c Andrea Spampinato, MD, d Stefano Favale, MD, e Alessandro Proclemer, MD, f Antonio Porfilio, MD, g Tiziana Marotta, MS, h Marco Vimercati, MS, h and Giuseppe Boriani, MD, PhD i on behalf of the DAPHNE study investigators j Piacenza, Como, Negrar, Roma, Udine, Milan, and Bologna, Italy 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 β-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 b .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 β-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. (Am Heart J 2008;156:373.e1-373.e8.) Atrial fibrillation (AF) is currently treated mainly by administering antiarrhythmic drugs. The attending physician determines the type, class, and dose of antiarrhythmic agents on a patient-by-patient basis to limit progression of the illness and to manage adverse effects. Nonpharmacologic therapies are becoming important alternatives in AF treatment because a rhythm-control strategy based only on drugs has proved to be ineffective. 1 The bradycardia-tachycardia form of sinus node disease (BT-SND) is an established indication to cardiac pacing according to the current international guidelines. 2 Results of trials on the prevention and/or termination of atrial tachyarrhythmias (ATAs) in such patient populations have been extensively published. 3-10 From the a Cardiology Department, Civile Hospital, Piacenza, Italy, b Cardiology Department, S. Anna Hospital, Como, Italy, c Cardiology Department, S. Cuore Hospital, Negrar, Italy, d Cardiology Department, C.d.C. Villa Tiberia, Roma, Italy, e Institute of Cardiology, University of Bari, Udine, Italy, f Cardiology Department, S.M. della Misericordia Hospital, Udine, Italy, g Cardiology Department, Fatebenefratelli-Villa S. Pietro Hospital, Roma, Italy, h Medtronic Italia, Clinical Department, Milan, Italy, and i Institute of Cardiology, University of Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy. j See Appendix for list of DAPHNE study investigators and steering and publication committee. Tiziana Marotta, Marco Vimercati are employees of Medtronic Italy affiliate to Medtronic Inc, Minneapolis, MN. Submitted June 20, 2007; accepted January 24, 2008. Reprint requests: Alessandro Capucci, MD, Ospedale Civile di Piacenza, Via Taverna 49, 29100 Piacenza (PC), Italy. E-mail: progettovita@hotmail.com 0002-8703/$ - see front matter © 2008, Mosby, Inc. All rights reserved. doi:10.1016/j.ahj.2008.01.032