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Randomized Controlled Trial
. 2013 May;34(20):1489-97.
doi: 10.1093/eurheartj/eht120. Epub 2013 Apr 16.

Lack of evidence of increased mortality among patients with atrial fibrillation taking digoxin: findings from post hoc propensity-matched analysis of the AFFIRM trial

Mihai Gheorghiade  1 , Gregg C Fonarow, Dirk J van Veldhuisen, John G F Cleland, Javed Butler, Andrew E Epstein, Kanan Patel, Inmaculada B Aban, Wilbert S Aronow, Stefan D Anker, Ali Ahmed
Affiliations
Randomized Controlled Trial

Lack of evidence of increased mortality among patients with atrial fibrillation taking digoxin: findings from post hoc propensity-matched analysis of the AFFIRM trial

Mihai Gheorghiade et al. Eur Heart J. 2013 May.

Abstract

Aims: Digoxin is recommended for long-term rate control in paroxysmal, persistent, and permanent atrial fibrillation (AF). While some analyses suggest an association of digoxin with a higher mortality in AF, the intrinsic nature of this association has not been examined in propensity-matched cohorts, which is the objective of the current study.

Methods and results: In Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM), 4060 patients with paroxysmal and persistent AF were randomized to rate (n = 2027) vs. rhythm (n = 2033) control strategies. Of these, 1377 received digoxin as initial therapy and 1329 received no digoxin at baseline. Propensity scores for digoxin use were estimated for each of these 2706 patients and used to assemble a cohort of 878 pairs of patients receiving and not receiving digoxin, who were balanced on 59 baseline characteristics. Matched patients had a mean age of 70 years, 40% were women, and 11% non-white. During the 3.4 years of the mean follow-up, all-cause mortality occurred in 14 and 13% of matched patients receiving and not receiving digoxin, respectively [hazard ratio (HR) associated with digoxin use: 1.06; 95% confidence interval (CI): 0.83-1.37; P = 0.640]. Among matched patients, digoxin had no association with all-cause hospitalization (HR: 0.96; 95% CI: 0.85-1.09; P = 0.510) or incident non-fatal cardiac arrhythmias (HR: 0.90; 95% CI: 0.37-2.23; P = 0.827). Digoxin had no multivariable-adjusted or propensity score-adjusted associations with these outcomes in the pre-match cohort.

Conclusions: In patients with paroxysmal and persistent AF, we found no evidence of increased mortality or hospitalization in those taking digoxin as baseline initial therapy.

Keywords: Atrial fibrillation; Digoxin; Hospitalization; Mortality; Propensity score.

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Figures

Figure 1
Figure 1
Flow chart displaying assembly of study cohorts.
Figure 2
Figure 2
Love plot displaying absolute standardized differences for 59 baseline characteristics between patients with atrial fibrillation receiving and not receiving digoxin as initial baseline therapy in AFFIRM, before and after propensity score matching (NYHA = New York Heart Association; BL = Therapy at baseline or at randomization to rate vs. rhythm control strategies; 6M = Therapy during 6 months prior to randomization to rate vs. rhythm control strategies).
Figure 3
Figure 3
Kaplan–Meier plots for all-cause mortality in propensity-matched AFFIRM patients with atrial fibrillation receiving and not receiving digoxin as initial therapy at baseline. *These percentages derived from Kaplan–Meier analysis are different from raw percentages presented in Table 3.
Figure 4
Figure 4
Association of the use of digoxin as baseline initial therapy with all-cause mortality in subgroups of propensity-matched AFFRIM participants with atrial fibrillation (*based on available data).
See this image and copyright information in PMC

Comment in

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