England: Treatment with low-dose digoxin or bisoprolol in patients with permanent atrial fibrillation and heart failure symptoms did not make any significant difference in quality of life at 6 months, reveals a recent study in the journal JAMA.
The trial included 160 patients (aged 60 years and older) with permanent atrial fibrillation (defined as no plan to restore sinus rhythm) and dyspnea classified as New York Heart Association class II or higher. The patients were recruited from 3 hospitals and primary care practices in England from 2016 through 2018; last follow-up occurred in October 2019.
The patients were randomized to receive either digoxin (n = 80; dose range, 62.5-250 μg/d; mean dose, 161 μg/d) or bisoprolol (n = 80; dose range, 1.25-15 mg/d; mean dose, 3.2 mg/d). Among 160 patients 145 (91%) completed the trial and 150 (94%) were included in the analysis for the primary outcome.
The primary end point was patient-reported quality of life using the 36-Item Short Form Health Survey physical component summary score (SF-36 PCS) at 6 months (higher scores are better; range, 0-100), with a minimal clinically important difference of 0.5 SD.
Key findings of the study include:
- There was no significant difference in the primary outcome of normalized SF-36 PCS at 6 months (mean, 31.9 for digoxin vs 29.7 for bisoprolol).
- Of the 17 secondary outcomes at 6 months, there were no significant between-group differences for 16 outcomes, including resting heart rate (a mean of 76.9/min with digoxin vs a mean of 74.8/min with bisoprolol; difference, 1.5/min).
- The modified EHRA class was significantly different between groups at 6 months; 53% of patients in the digoxin group reported a 2-class improvement vs 9% of patients in the bisoprolol group (adjusted odds ratio, 10.3).
- At 12 months, 8 of 20 outcomes were significantly different (all favoring digoxin), with a median NT-proBNP level of 960 pg/mL in the digoxin group vs 1250 pg/mL in the bisoprolol group (ratio of geometric means, 0.77).
- Adverse events were less common with digoxin; 20 patients (25%) in the digoxin group had at least 1 AE vs 51 patients (64%) in the bisoprolol group.
- There were 29 treatment-related AEs and 16 serious AEs in the digoxin group vs 142 and 37, respectively, in the bisoprolol group.
"Among patients with permanent atrial fibrillation and symptoms of heart failure treated with low-dose digoxin or bisoprolol, there was no statistically significant difference in quality of life at 6 months, " wrote the authors.
"These findings support potentially basing decisions about treatment on other end points," they concluded.
"Effect of Digoxin vs Bisoprolol for Heart Rate Control in Atrial Fibrillation on Patient-Reported Quality of Life: The RATE-AF Randomized Clinical Trial," is published in the journal JAMA.
DOI: https://jamanetwork.com/journals/jama/fullarticle/2774407
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