Estudio Piloto Argentino de Muerte Subita y Amioda rone (Argentine Pilot Study of Sudden Death and Amiodarone) - EPAMSA
Amiodarone for 1-year mortality in patients with reduced LV function.
Amiodarone will reduce sudden death by 50%, and therefore overall mortality by 25%, in patients with poor ventricular function and asymptomatic complex ventricular arrhythmias (ACVA).
Patients Screened: Not given
Patients Enrolled: 106
Mean Follow Up: 12 months
Mean Patient Age: 61 ± 9 years
Female: Amiodarone = 18%; control group = 27%
Mean Ejection Fraction: 27 ± 7%
Age 40 to 75 years
Left ventricular ejection fraction at rest < 35%
ACVA without clinical heart failure or electrolyte abnormalities
Results of routine laboratory analysis within normal limits
Requirement for antiarrhythmic therapy as determined by the physician
Clinical instability (acute myocarditis, unstable angina, acute myocardial infarction (MI), or cardiac surgery in the preceding 3 months, cardiac failure decompensation or terminal disease)
Contraindications for the use of amiodarone
Congestive heart failure death
Other cardiac death
Amiodarone, 800 mg/day for 2 weeks, 400 mg/day thereafter for 12 months
Vasodilators, mainly angiotensin-converting enzyme inhibitors (88%)
Amiodarone reduced the overall mortality rate (10.5% vs 28.6% in control group; odds ratio 0.29; 95% confidence interval [CI] 0.19 to 0.84; log-rank test 0.02)
Amiodarone also reduced the sudden-death rate (7.0%% vs 20.4% in control group; odds ratio 0.29; 95% CI 0.08 to 1.00; log-rank test 0.04)
Side effects were rare; in only 3 patients did amiodarone treatment have to be discontinued.
Amiodarone treatment was associated with a 71% reduction in overall and sudden death mortality at 1 year in patients with poor ventricular function and ACVA of diverse causes. Nevertheless, because the sample was small, these findings required further confirmation in more extensive randomized trials.
1. Am Heart J 1995;130:494-500. Final results
Keywords: Tachycardia, Ventricular, Ventricular Fibrillation, Heart Failure, Stroke Volume, Ventricular Function, Death, Sudden, Cardiac
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