Estudio Piloto Argentino de Muerte Subita y Amioda rone (Argentine Pilot Study of Sudden Death and Amiodarone) - EPAMSA

Feb 04, 2002
Font Size
A
A
A
Date Published:
01/01/1995
Date Updated:
02/04/2002
Original Posted Date:
02/04/2002
References

Description:

Amiodarone for 1-year mortality in patients with reduced LV function.

Hypothesis:

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).

Study Design

Study Design:

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%

Patient Populations:

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

Exclusions:

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

Primary Endpoints:

Sudden death
Congestive heart failure death
Other cardiac death
Noncardiac death

Drug/Procedures Used:

Amiodarone, 800 mg/day for 2 weeks, 400 mg/day thereafter for 12 months

Concomitant Medications:

Vasodilators, mainly angiotensin-converting enzyme inhibitors (88%)

Principal Findings:

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.

Interpretation:

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.

References:

1. Am Heart J 1995;130:494-500. Final results

Keywords: Tachycardia, Ventricular, Ventricular Fibrillation, Heart Failure, Stroke Volume, Ventricular Function, Death, Sudden, Cardiac


< Back to Listings