Dronedarone for the control of ventricular rate in permanent atrial fibrillation: the Efficacy and safety of dRonedArone for the cOntrol of ventricular rate during atrial fibrillation (ERATO) study.

BACKGROUND: Dronedarone is a new multichannel blocker for atrial fibrillation (AF) previously demonstrated to have both rhythm and rate control properties in paroxysmal and persistent AF. The Efficacy and safety of dRonedArone for The cOntrol of ventricular rate during atrial fibrillation (ERATO) trial assessed the efficacy of dronedarone in the control of ventricular rate in patients with permanent AF, when added to standard therapy. METHODS: In this randomized, double-blind, multinational trial, dronedarone, 400 mg twice a day (n = 85), or matching placebo (n = 89) was administered for 6 months to adult patients with permanent AF, in addition to standard therapy. The primary end point was the change in mean ventricular rate between baseline and day 14, as assessed by 24-hour Holter. Ventricular rate was also assessed during submaximal and maximal exercise. RESULTS: Dronedarone significantly decreased mean 24-hour ventricular rate. Compared with placebo, the mean treatment effect at day 14 was a reduction of 11.7 beats per minute (beat/min; P < .0001). Comparable reductions were sustained throughout the 6-month trial. During maximal exercise and compared to placebo, there was a mean reduction of 24.5 beat/min (P < .0001), without any reduction in exercise tolerance as measured by maximal exercise duration. The effects of dronedarone were additive to those of other rate-control agents, including beta-blockers, calcium antagonists, and digoxin. Dronedarone was well tolerated, with no organ toxicities or proarrhythmia. CONCLUSION: In addition to its reported rhythm-targeting and rate-targeting therapeutic actions in paroxysmal and persistent AF, dronedarone improves ventricular rate control in patients with permanent AF. Dronedarone was well tolerated with no evidence of organ toxicities or proarrhythmias in this short-term study.

A comparison of rate control and rhythm control in patients with recurrent persistent atrial fibrillation.

BACKGROUND: Maintenance of sinus rhythm is the main therapeutic goal in patients with atrial fibrillation. However, recurrences of atrial fibrillation and side effects of antiarrhythmic drugs offset the benefits of sinus rhythm. We hypothesized that ventricular rate control is not inferior to the maintenance of sinus rhythm for the treatment of atrial fibrillation. METHODS: We randomly assigned 522 patients who had persistent atrial fibrillation after a previous electrical cardioversion to receive treatment aimed at rate control or rhythm control. Patients in the rate-control group received oral anticoagulant drugs and rate-slowing medication. Patients in the rhythm-control group underwent serial cardioversions and received antiarrhythmic drugs and oral anticoagulant drugs. The end point was a composite of death from cardiovascular causes, heart failure, thromboembolic complications, bleeding, implantation of a pacemaker, and severe adverse effects of drugs. RESULTS: After a mean (+/-SD) of 2.3+/-0.6 years, 39 percent of the 266 patients in the rhythm-control group had sinus rhythm, as compared with 10 percent of the 256 patients in the rate-control group. The primary end point occurred in 44 patients (17.2 percent) in the rate-control group and in 60 (22.6 percent) in the rhythm-control group. The 90 percent (two-sided) upper boundary of the absolute difference in the primary end point was 0.4 percent (the prespecified criterion for noninferiority was 10 percent or less). The distribution of the various components of the primary end point was similar in the rate-control and rhythm-control groups. CONCLUSIONS: Rate control is not inferior to rhythm control for the prevention of death and morbidity from cardiovascular causes and may be appropriate therapy in patients with a recurrence of persistent atrial fibrillation after electrical cardioversion.

The contribution of rate adaptive pacing with single or dual sensors to health-related quality of life.

AIMS: The characteristics of sensors to perform rate adaptive pacing are well established but whether their contribution improves health-related quality of life (QoL) remains disputable. To compare the effects on QoL with an integrated dual sensor [minute ventilation (MV) and acceleration, TT sensor] with a single MV sensor, and with no rate adaptive pacing. METHODS AND RESULTS: This Dutch multi centre, prospective, single- (patient) blind study was performed in patients after first pacemaker (PM) implant for sick sinus syndrome or AV block. After a 3-month 'sensor off'-period following DDD PM implantation, where the latter 2 months permitted the MV sensor to learn the intrinsic rhythm, a 2-month period of DDDR with TT sensor or 2 months of DDDR with MV sensor, subsequently the two modes were crossed over. Quality of life was determined with Aquarel, the disease-specific instrument for PM patients. Heart rate, percentages of sensor driven and intrinsic rhythm were retrieved from PM memories. Sixty-four patients completed the 7-month study. In sick sinus patients, percentages of sensor-driven pacing occurred significantly more frequently than in AV block patients After implant QoL improved significantly: before 71.3 and after 83.5% (P < 0.001) measured with Aquarel and in 3 of 9 SF-36 scales, but no significant additive QoL benefit with dual or MV sensor pacing was observed. Pacing diagnosis, percentages of rate adaptive pacing, and heart rate influencing medication did not influence this result. CONCLUSION: Pacemaker implantation strongly improves QoL, but neither single- nor dual- sensor-driven pacing offered additional improvement in QoL during the initial 8 months after the first PM implant.