SOURCE: Washam JB, et al. Digoxin use in patients with atrial fibrillation and adverse cardiovascular outcomes: A retrospective analysis of the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF). Lancet 2015;385:2363-2370.

Beta-blockers, calcium channel blockers, and digoxin are among the commonly used choices for rate control in patients with atrial fibrillation (AF). The role of digoxin is based on limited data, most of which is not recent. Large clinical trials of novel anticoagulants for patients with AF have been completed within the last decade. Since a substantial minority of patients enrolled in AF anticoagulant trials were receiving digoxin as part of their therapeutic regimen, these data provide a window of observation about associations of digoxin with outcomes.

The Rivaroxaban Once Daily Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET-AF) enrolled more than 14,000 patients with AF to compare rivaroxaban with warfarin. More than 5000 AF patients were being treated with digoxin at baseline (37% of total ROCKET-AF participants).

At a median follow-up of approximately 2 years, digoxin treatment was associated with increased all-cause mortality (17% relative increase), vascular death (19% relative increase), and sudden death (36% relative increase).

Because these results have been obtained from a post-hoc analysis of a clinical trial, they cannot be regarded as definitive. Nonetheless, the results should prompt reconsideration of the various choices available for rate control in AF, and hopefully will stimulate performance of a randomized trial to provide more conclusive evidence.