Blinded withdrawal of randomized treatment with low-dose digoxin or placebo in heart failure: the DECISION trial.
Peter van der Meer, Dirk J van Veldhuisen, Geert H D Voordes et al.
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In 30 seconds
This pre-specified analysis of the multicentre, randomised DECISION trial examined blinded withdrawal of long-term low-dose digoxin or placebo in patients with heart failure and reduced or mildly reduced ejection fraction receiving contemporary guideline-recommended therapy. After a median 36.5 months of treatment, 587 patients underwent withdrawal and were followed in person at 6 weeks. Cardiovascular death or worsening heart failure events after withdrawal occurred at 42.8 vs 5.9 events per 100 patient-years in the digoxin and placebo withdrawal groups, respectively (rate ratio 7.37, 95% CI 1.56-34.88; P = .012).
Key findings
- After withdrawal, 14 events occurred in the digoxin group versus two in the placebo group (rate ratio 7.37, 95% CI 1.56-34.88; P = .012).
- Event rates rose after digoxin withdrawal but not placebo withdrawal: 42.8 vs 5.9 events per 100 patient-years; interaction P = .036.
- Digoxin withdrawal was accompanied by increased heart rate (P = .003), lower systolic blood pressure (P = .014), and higher NT-proBNP (P = .002).
Why it matters
The findings suggest that stopping long-term digoxin may be followed by short-term clinical deterioration in patients with reduced or mildly reduced ejection fraction, even when receiving contemporary guideline-recommended therapy. The accompanying changes in heart rate, blood pressure, and NT-proBNP provide additional evidence of physiological change after withdrawal. This is relevant when weighing discontinuation, while recognising the limits of the withdrawal analysis.
What to keep in mind
The withdrawal analysis included 587 patients and assessed outcomes at a 6-week follow-up; the reported post-withdrawal observation was short.