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Digoxin therapy and associated clinical outcomes in the MADIT-CRT trial
Andy Y Lee1, Valentina Kutyifa1, Martin H Ruwald2
1Heart Research Follow-Up Program, University of Rochester Medical Center, Rochester, New York.
Insights
Digoxin did not improve outcomes for mild heart failure patients with defibrillator devices. However, it increased the risk of high-rate ventricular tachycardia or fibrillation (VT/VF) in these patients.
Area of Science:
- Cardiology
- Pharmacology
- Medical Devices
Background:
- Digoxin's properties are known, but its role in modern heart failure (HF) treatment requires further investigation.
- Patients with mild HF often receive implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy with defibrillator (CRT-D) devices.
Purpose of the Study:
- To evaluate the impact of digoxin on clinical outcomes in patients with mild HF who have ICD or CRT-D devices.
- To determine if digoxin affects heart failure events, mortality, or life-threatening ventricular arrhythmias.
Main Methods:
- Analysis of 1820 patients with mild HF (NYHA class I-II), prolonged QRS, and reduced ejection fraction from the MADIT-CRT trial.
- Multivariate Cox regression models assessed the effect of time-dependent digoxin use on HF/death, HF alone, death alone, and ventricular tachycardia/fibrillation (VT/VF).
Main Results:
- Digoxin use was not linked to significant changes in HF/death, HF alone, or death alone.
- Digoxin was associated with a 41% increased risk of VT/VF, particularly high-rate VT/VF (≥200 beats/min).
- No significant differences in digoxin's effects were observed between ICD and CRT-D patients.
Conclusions:
- Digoxin does not reduce HF/death events in mild HF patients with ICD/CRT-D devices.
- Digoxin therapy is associated with an increased risk of high-rate VT/VF in this patient population.
Background:
Digoxin's pharmacological, hemodynamic, and electrophysiological properties are well understood. However, in modern heart failure (HF) treatment, its effect has 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 (≥130 ms), and reduced left ventricular ejection fraction (≤30%) 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 = .0.56), HF alone (HR 1.1.04; 95% CI 0.82-1.32; P = .76), or death alone (HR 0.93; 95% CI 0.67-1.32; P = .71). However, digoxin was associated with a significant 41% increased risk of VT/VF (HR 1.41; 95% CI 1.14-1.75; P = .002), which was driven by a significantly increased risk of VT/VF with heart rate ≥200 beats/min (HR 1.65; 95% CI 1.27-2.15; P ≤ .001), whereas no increased risk of VT/VF with heart rate <200 beats/min was evident (HR 1.20; 95% CI 0.92-1.57; P = .19). No significant differences in digoxin's effect on any of the end points were found between patients with ICD and patients with CRT-D (interaction P > .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 (≥200 beats/min).
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