Problem High-risk permanent AF
Format Double-blinded multi-center RCT
Treatment Dronedarone
Control Placebo
Population 3236 patients
Inclusion criteria Permanent atrial fibrillation or flutter, as documented on electrocardiography performed both within 14 days before randomization and 6 or more months beforehand, who had no evidence of intervening sinus rhythm and for whom there was no plan to restore sinus rhythm

Aged >65 years with at least one of:

Coronary artery disease
Previous stroke or transient ischemic attack
Symptomatic heart failure, which was defined as current New York Heart Association class II or III symptoms and admission to the hospital for heart failure in the previous year (but not in the most recent month)
Left ventricular ejection fraction of 40% or less
Peripheral arterial disease

OR the combination of an age of 75 years or older, hypertension, and diabetes.
Exclusion criteria Paroxysmal or persistent atrial fibrillation
Use of an implantable cardioverter–defibrillator
Sustained daytime bradycardia of less than 50 beats per minute
QT interval corrected for heart rate of more than 500 msec (or >530 msec for patients with a paced ventricular rhythm).
Follow-up STOPPED EARLY - Median 3.5 months
Primary endpoint 2 Coprimary outcomes
1) Stroke, myocardial infarction, systemic embolism, or death from cardiovascular causes
2) Unplanned hospitalization for a cardiovascular cause or death.
Secondary endpoint(s) Death from cardiovascular causes
Death from arrhythmia
Recurrent hospitalization for cardiovascular causes
Total nights in the hospital for cardiovascular reasons
Acute coronary syndrome
Stroke or systemic embolism
Hospitalization for heart failure or heart-failure episode without hospitalization
Death from any cause.

Patients who were at least 65 years of age with at least a 6-month history of permanent atrial fibrillation and risk factors for major vascular events
Brief summary: Followed ATHENA; showed dronedarone kills high risk AF patients
PAPER: Dronedarone in High-Risk Permanent Atrial Fibrillation
Date 14 Nov 2011
Journal N Engl J Med. 2011 Nov 14. [Epub ahead of print]
Information N.B. STOPPED EARLY

Increased rates of
-Heart failure
-Death from cardiovascular causes