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in the MADIT-CRT trial

BACKGROUND Digoxin’s pharmacological, hemodynamic, and electrophysiological properties are well understood. However, in modern heart failure (HF) treatment, itseffecthas yet to be fully investigated. OBJECTIVE The aim of the present study was to determine the effects of digoxin on outcomes in patients with mild HF implanted with an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy with defibrillator (CRT-D) device. METHODS We investigated the effect of digoxin treatment on the end points of HF/death, HF alone, death alone, and ventricular tachycardia or ventricular fibrillation (VT/VF) in 1820 patients with mild HF (New York Heart Association class I and II), prolonged QRS duration (Z130 ms), and reduced left ventricular ejection fraction (r30%) enrolled in the Multicenter Automatic Defibrillator Implantation Trial – Cardiac Resynchronization Therapy trial. Multivariate Cox proportional hazards regression models were used to determine the effect of time-dependent digoxin usage on the end points. RESULTS Digoxin therapy was not associated with an increased or decreased risk of HF/death (hazard ratio [HR] 1.07; 95% confidence interval [CI] 0.86–1.33; P ¼ .0.56), HF alone (HR 1.1.04; 95% CI 0.82–1.32; P ¼ .76), or death alone (HR 0.93; 95% CI 0.67–1.32; P ¼ .71). However, digoxin was associated with a significant 41% increased risk of VT/VF (HR 1.41; 95% CI 1.14–1.75; P ¼ .002), which was driven by a significantly increased risk of VT/VF with heart rate Z200 beats/min (HR 1.65; 95% CI 1.27–2.15; P r .001), whereas no increased risk of VT/VF with heart rate o200 beats/min was evident (HR 1.20; 95% CI 0.92–1.57; P ¼ .19). No significant differences in digoxin’s effect on any of the end points were found between patients with ICD and patients with CRTD (interaction P 4 .5). CONCLUSION The use of digoxin in patients with mild HF implanted with an ICD or CRT-D device was not associated with reductions in HF/death events. However, digoxin therapy was associated with an increased risk of high-rate VT/VF (Z200 beats/min).