On April 14, 1997, the National Institutes of Health announced that it had
stopped the Antiarrhythmics Vs. Implantable Defibrillator Trial (AVID). This
action was prompted by a significant reduction in mortality in patients
treated with an implantable cardioverter-defibrillator (ICD).
This landmark study represents the first multi-center, randomized,
controlled trial to demonstrate that the ICD improves overall survival in
patients with life-threatening ventricular arrhythmias.
The AVID trial enrolled patients with a history of life-threatening
arrhythmias, defined as ventricular fibrillation or ventricular tachycardia.
Since the study began in 1993, 1016 patients were enrolled at over 50
centers around the United States. The mean age of these patients was 65
years. Patients were randomized to treatment with an implantable
cardioverter-defibrillator or treatment with the antiarrhythmic drugs
amiodarone or sotalol.
After one year, patients in the defibrillator group experienced a 38%
reduction in deaths as compared to patients treated with antiarrhythmic
drugs. A 25% reduction in mortality was demonstrated over years 2 and 3 of
follow-up. The difference at 3 years remained highly significant. As Dr.
Claude Lenfant, Director of the National Heart, Lung and Blood Institute,
stated in the official press release, "If we apply the results of AVID to
the population at risk, over 1000 lives would be saved each year in the
U.S."
The Arrhythmia Service at St. Luke's-Roosevelt Hospital Center, a leading
enroller nationally, was made aware of the results and early termination of
the trial at an investigators meeting on April 9. Our offices immediately
began notifying patients of the results, which were soon to be released to
the public. Our recommendation to patients randomized to antiarrhythmic drug
therapy who have been under treatment for less than 1 year is to undergo
early ICD implantation. After the initial 1 year period, mortality rates are
not significantly different; patients should be treated on an individual
basis. If you have questions regarding any of your patients who have
participated in the trial or to whom the results may apply, please contact
the Arrhythmia Service directly at (212) 523-4007.
Full results of the trial, including details of the mortality differences
between the treatment groups and cost and quality-of-life analysis which
were also a major part of the trial, will be made available in a
presentation to be made at the upcoming meeting of the North American
Society of Pacing and Electrophysiology (NASPE) in May. As these results
become available to us, we will forward them to you through direct
communications and through The Arrhythmia News.
In summary, the AVID trial represents the first large-scale, controlled
trial to demonstrate that the ICD improves overall survival in patients with
life-threatening ventricular arrhythmias. This study demonstrates that
patients presenting with cardiac arrest as the result of ventricular
fibrillation or ventricular tachycardia should be treated with a
defibrillator!