Trial reportEuropace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology2025
Atrial fibrillation and implantable cardioverter-defibrillator in non-ischaemic heart failure with reduced ejection fraction: insights from the DANISH trial.
Trial report in Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00542945 (A DANish Randomized, Controlled, Multicenter Study to Assess the Efficacy of Implantable Cardioverter Defibrillator in Patients With Non-ischemic Systolic Heart Failure on Mortality. The DANISH Study), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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A DANish Randomized, Controlled, Multicenter Study to Assess the Efficacy of Implantable Cardioverter Defibrillator in Patients With Non-ischemic Systolic Heart Failure on Mortality. The DANISH Study
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Abstract
aimsAtrial fibrillation (AF) is associated with an increased risk of sudden cardiac death. Therefore, the effect of an implantable cardioverter-defibrillator (ICD) may be greater in patients with AF. We examined the long-term effects of primary prevention ICD implantation vs. usual clinical care according to AF status in DANISH. METHODS AND
resultsOutcomes were analysed according to AF status at baseline (history and/or on enrollment ECG). The primary outcome was all-cause death, and secondary outcomes were cardiovascular and sudden cardiovascular death. Of the 1116 patients with non-ischaemic heart failure with reduced ejection fraction randomized in DANISH, 418 (37.5%) had AF at baseline, of whom 24.2% had paroxysmal AF, 17.0% persistent AF, and 58.9% permanent AF. AF status did not significantly modify the effect of ICD implantation on all-cause death, although there was a suggestion of a greater effect in patients with [hazard ratio (HR) 0.78 (95% CI, 0.59-1.03)] vs. without AF [HR 0.98 (0.75-1.27)] (Pinteraction = 0.15). AF status significantly modified the effect of ICD implantation on cardiovascular death, such that ICD implantation was associated with a lower rate of this outcome in patients with AF [HR 0.67 (0.48-0.94)], but not in those without AF [HR 1.04 (0.76-1.41)] (Pinteraction = 0.04). Although AF status did not significantly modify the effect of ICD implantation on sudden cardiovascular death, there was a suggestion of a greater effect in patients with [HR 0.45 (0.24-0.82)] vs. without AF [HR 0.76 (0.41-1.38)] (Pinteraction = 0.20).
conclusionIn the DANISH trial, the presence of AF was associated with a greater effect of ICD implantation on cardiovascular death, and although similar trends were observed for all-cause and sudden cardiovascular death, the treatment-by-subgroup interaction was not statistically significant for these outcomes. REGISTRATION: URL: https://www.clinicaltrials.gov; unique identifier: NCT00542945.
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