Trial reportEuropean heart journal2026
Blinded withdrawal of randomized treatment with low-dose digoxin or placebo in heart failure: the DECISION trial.
Trial report in European heart journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
12 authors.
Funding
Abstract
BACKGROUND AND
aimsWhether digoxin withdrawal is safe in patients with heart failure (HF) optimized on contemporary guideline-recommended medical therapy remains unknown. This pre-specified analysis of the DECISION trial evaluated outcomes following blinded withdrawal of digoxin or placebo.
methodsIn DECISION, 1001 patients were randomized to low-dose digoxin or placebo and treated for a median of 36.5 months. At the end of the study, 587 patients on active treatment (digoxin 288 and placebo 299) underwent blinded withdrawal with an in-person follow-up visit at 6 weeks. All events were adjudicated.
resultsDuring the pre-withdrawal phase (100 days), incidence rates of cardiovascular (CV) death or worsening HF events were 5.7 vs 6.5 events per 100 patient-years in the digoxin vs placebo group; rate ratio (RR) 0.88; 95% confidence interval (CI) [0.24-3.10]. Following withdrawal, the incidence rate increased markedly in patients withdrawn from digoxin but not placebo (42.8 vs 5.9 events per 100 patient-years; time period-by-treatment interaction, P = .036). Fourteen events (12 hospitalizations and 2 urgent HF visits) occurred in the digoxin withdrawal arm vs two (one HF hospitalization and one CV death) in the placebo withdrawal arm (RR 7.37, 95% CI 1.56-34.88; P = .012). Withdrawal of digoxin was accompanied by an increase in heart rate (P = .003), reduction in systolic blood pressure (P = .014), and rise in NT-proBNP (P = .002).
conclusionsDiscontinuation of digoxin after long-term treatment is associated with clinical deterioration in patients with HF and a reduced or mildly reduced ejection fraction. These findings warrant caution when stopping digoxin.
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