Acronym: A Trial with Dronedarone to Prevent Hospitalization or DEath in PatieNts With Atrial Fibrillation
Purpose: Evaluated dronedarone versus placebo in patients with paroxysmal or persistent atrial fibrillation.
Format: randomized, double-blind, placebo-controlled
Treatment Group: dronedarone 400 mg
Control Group: placebo
Number of Patients: 4,628
Number of Centers: 551 centers in 37 countries
- Paroxysmal or persistent atrial fibrillation or flutter
- AND at least one of the following requirements:
- Age of at least 70 years
- Arterial hypertension (with ongoing therapy involving at least two antihypertensive drugs of different classes); diabetes mellitus
- Previous stroke, transient ischemic attack, or systemic embolism
- Left atrial diameter greater than or equal to 50 mm
- Left ventricular ejection fraction less than or equal to 40%
- Permanent atrial fibrillation
- An unstable hemodynamic condition
- New York Heart Association (NYHA) class IV congestive heart failure planned major surgery
- Acute myocarditis
- Bradycardia with a heart rate of less than 50 beats per minute or a PR interval of more than 0.28 second
- Previous clinically significant sinus-node disease
Primary Endpoints: first hospitalization due to CV events or all-cause mortality
Follow-up: days 7 and 14 and at months 1, 3, 6, 9, and 12 and every 3 months thereafter until December 30, 2007
In the ATHENA trial, there was a 24% relative risk reduction in cardiovascular hospitalization or death, 30% reduction in cardiovascular death, 45% reduction in deaths from arrhythmia and a non-significant 17% reduction in all-cause mortality with those randomly assigned dronedarone compared with placebo.
Hohnloser SH, et al. N Engl J Med. 2009;doi:10.1056/NEJMoa0803778.