Dronedarone could prevent progression to permanent AF/atrial flutter
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Dronedarone was associated with lower incidence of permanent atrial fibrillation/atrial flutter, more return to permanent sinus rhythm and lower AF/atrial flutter burden vs. placebo, according to a post hoc analysis of the ATHENA trial.
“ATHENA is the largest clinical trial to date assessing clinical outcomes in AF patients using an antiarrhythmic drug,” Carina Blomström-Lundqvist, MD, PhD, professor in the department of cardiology at the School of Medical Sciences, faculty of medicine and health at Orebro University Hospital in Orebro, Sweden, and colleagues wrote. “In this post hoc analysis, the effect of dronedarone on the progression of AF/atrial flutter was evaluated using the cumulative incidence of presumed permanent AF/atrial flutter and estimated AF/atrial flutter burden using the modified Rosendaal method. To our knowledge, this is the first study to apply this methodology in the context of estimating AF/atrial flutter burden.”
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Blomström-Lundqvist and colleagues conducted a post hoc analysis of the randomized controlled ATHENA trial that tested the efficacy of dronedarone (Multaq, Sanofi) for the prevention of CV hospitalization or death in patients with paroxysmal or persistent AF/atrial flutter.
As Healio previously reported, in the main results of ATHENA, dronedarone reduced CV hospitalizations or death in patients with AF/atrial flutter by 24% compared with placebo and reduced time to first hospitalization by 25.5%.
For the present analysis of ATHENA trial, Blomström-Lundqvist and colleagues evaluated the effect of dronedarone on the progression of AF/atrial flutter to presumed permanent AF/atrial flutter estimated using a modified Rosendaal method and available ECGs, and regression to sinus rhythm compared with placebo.
Permanent AF/atrial flutter was defined as 6 months or more of AF/atrial flutter until the end of the study, and permanent sinus rhythm was defined as 6 months or more of sinus rhythm until the end of the study.
The analysis included 4,439 ATHENA participants, of whom 2,208 received dronedarone and 2,231 received placebo, between whom baseline characteristics were well balanced, according to the study.
The findings were published in EP Europace.
The researchers observed progression to permanent AF/atrial flutter in 13.8% of the dronedarone group compared with 20.4% of the placebo group (P < .0001).
Compared with placebo, dronedarone was associated with:
- lower cumulative incidence of permanent AF/atrial flutter (HR = 0.65; 95% CI, 0.56-0.75; log-rank P < .001);
- higher incidence of permanent sinus rhythm (HR = 1.19; 95% CI, 1.09-1.29; log-rank P < .001); and
- lower AF/atrial flutter burden over time estimate using the modified Rosendaal method (P from day 14 to month 21 < .01).
“The positive effects on progression, regression, and AF/atrial flutter burden suggest that dronedarone may reverse atrial and ventricular remodeling,” the researchers wrote. “The positive effects on AF/atrial flutter burden, and on AF progression and regression by dronedarone in the current study suggest dronedarone may be a preferred treatment option early in the course of AF, particularly given its low pro-arrhythmic risk.”
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