Cardiovascular Outcomes in the AFFIRM Trial (Atrial Fibrillation Follow-Up Investigation of Rhythm Management): An Assessment of Individual Antiarrhythmic Drug Therapies Compared With Rate Control With Propensity Score-Matched Analyses

Study Questions:

How do individual rhythm-control agents affect cardiovascular outcomes in patients with atrial fibrillation (AF)?


In this post hoc analysis of the AFFIRM trial, the primary outcome of all-cause mortality or first cardiovascular hospitalization was evaluated in patients (mean age 70 years) with AF treated with amiodarone (n = 729), sotalol (n = 606), and flecainide or propafenone (n = 268). These groups were compared to propensity-score-matched subgroups treated with a rate-control strategy.


Compared to rate control, the primary outcome occurred significantly more often in the amiodarone (hazard ratio [HR], 1.18) and sotalol (HR, 1.32) groups. The rate of first cardiovascular hospitalization at 3 years was significantly higher in the amiodarone, sotalol, and flecainide/propafenone groups (47%, 50%, and 44%, respectively) than in the matched rate-control groups (36-40%). Cardiovascular mortality did not differ significantly between any of the groups. Compared to the rate-control cohort, noncardiovascular mortality was higher in the amiodarone group (HR, 1.11).


In the AFFIRM trial, rhythm-control agents had no effect on all-cause mortality, but were associated with an increased risk of cardiovascular hospitalizations. Amiodarone, but not sotalol or flecainide/propafenone, was associated with an 11% increase in the risk of noncardiovascular mortality.


Prior studies have suggested that amiodarone may be associated with an increased risk of death from pulmonary disease or cancer, and this may explain the higher risk of noncardiovascular death in the amiodarone group in this study.

Clinical Topics: Arrhythmias and Clinical EP, EP Basic Science

Keywords: Neoplasms, Follow-Up Studies, Propensity Score, Electric Countershock, Propafenone, Sotalol, Flecainide, Lung Diseases

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