ATHENA Trial

Trial Details

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

Inclusion Criteria:

• 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%

Exclusion Criteria:

• 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

Summary:

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.

Original Publication:

Hohnloser SH, et al. N Engl J Med. 2009;doi:10.1056/NEJMoa0803778.