In patients with a history of life-threatening ventricular arrhthmias, can treatment with ICD of antiarrthmic drugs improve outcomes?
ICD implantation is superior to antiarrhythmic drugs in patients with a history of ventricular arrhythmia.
This 1997 landmark study compared antiarrythmics (amiodarone or sotalol)to ICD implantation was stopped early when outcomes between the two groups reached statistical significance. Fewer deaths occurred among the patients assigned to receive an implantable defibrillator (80 deaths) than in the antiarrhythmic-drug group (122).
- Multicenter, randomized, controlled trial
- 6035 patients screened
- N= 1885 eligable, 1016 randomized.
- ICD implantation (n=507)
- Antiarrhythmic therapy (n=509)
- Mean follow-up: 18.2 months
- Analysis: Intention-to-treat
- Primary outcome: Death
- Patients resuscitated from near fatal ventricular fibrillation
- Patients with sustained ventricular tachycardia with syncope
- Patients with sustained ventricular tachycardia with an LVEF less than 40% and symptoms of hemodynamic compromise due to arryhthmia.
- If patients were revascularized, LVEF had to be less than 40%.
- Mean age: 65 years
- Male: 79%
- Mean LVEF 29%
- Randomized to ICD implantation or antiarrythmic therapy with amiodarone or sotalol.
- Patients evaluated every three months.
Comparisons are intensive therapy vs. standard therapy.
- Fewer deaths occurred among the patients assigned to receive an implantable defibrillator (80
deaths) than in the antiarrhythmic-drug group (122).
- Time to rehospitalization
- 83% in defibrillator group
- 75.5% in Antiarrhthmic drug group