Impact of Dronedarone on Hospitalization Burden in Patients With Atrial Fibrillation: Results From the ATHENA Study

Study Questions:

What is the effect of dronedarone on hospitalizations in patients with atrial fibrillation (AF)?


This was a post hoc analysis of a double-blind, randomized clinical trial in which patients (mean age 72 years) with paroxysmal or persistent AF and ≥1 risk factor for stroke were treated with placebo (n = 2,327) or dronedarone, 400 mg twice daily (n = 2,301), and followed for a mean of 22 months. Hospitalizations were classified as cardiovascular or noncardiovascular.


The number of first cardiovascular hospitalizations was significantly lower by 26% in the dronedarone group. Dronedarone significantly decreased the number of hospitalizations for AF and acute coronary syndrome, but had no effect on noncardiovascular hospitalizations. The total number of cardiovascular hospitalization days was significantly lower in the dronedarone group (4,792 days) than in the placebo group (5,807 days), as was the total number of AF hospitalization days (2,092 and 2,837, respectively).


The authors concluded that the risk of cardiovascular hospitalization and the total hospitalization burden in patients with AF and ≥1 risk factor for stroke are significantly reduced by dronedarone.


In the ATHENA trial, dronedarone had a neutral effect on all-cause mortality. Of note is that a large randomized clinical trial of dronedarone in patients with permanent AF and ≥1 cardiovascular risk factor was prematurely suspended in July 2011, after enrollment of approximately 3,100 patients, because of a significantly greater event rate (i.e., cardiovascular death, myocardial infarction, stroke, embolism) in the dronedarone arm than in the placebo arm. Detailed results are not yet available, but for the present, it would seem prudent to limit the use of dronedarone to patients whose AF is not permanent and who do not have cardiovascular risk factors.

Clinical Topics: Acute Coronary Syndromes

Keywords: Myocardial Infarction, Acute Coronary Syndrome, Stroke, Risk Factors, Embolism, Hospitalization

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