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Trial question
Is antiarrhythmic therapy superior to no antiarrhythmic therapy in patients with coronary artery disease, a LVEF of ≤ 40%, and asymptomatic, unsustained VT in whom sustained ventricular tachyarrhythmias were induced by programmed stimulation?
Study design
Multi-center
Single blinded
RCT
Population
Characteristics of study participants
10.0% female
90.0% male
N = 704
704 patients (70 female, 634 male)
Inclusion criteria: patients with coronary artery disease, an LVEF of ≤ 40%, and asymptomatic, unsustained VT in whom sustained ventricular tachyarrhythmias were induced by programmed stimuation
Key exclusion criteria: history of syncope, or sustained VT or fibrillation > 48 hours after the onset of acute myocardial infarction; systemic disease likely to be fatal in < 2 years; and ≥ 80 years of age
Interventions
N=351 antiarrhythmic therapy (drugs and implantable defibrillators, as indicated by the results of electrophysiologic testing)
N=353 no antiarrhythmic therapy (electrophysiologic testing without antiarrhythmic therapy)
Primary outcome
Cardiac arrest or death from arrhythmia
25
32
32.0 %
24.0 %
16.0 %
8.0 %
0.0 %
Antiarrhythmic therapy
No antiarrhythmic therapy
Significant decrease ▼
NNT = 14
Significant decrease in cardiac arrest or death from arrhythmia (25% vs. 32%; RR 0.73, 95% CI 0.53 to 0.99)
Secondary outcomes
No significant difference in death at 5 years (42% vs. 48%; RR 0.8, 95% CI 0.64 to 1.01)
Significant decrease in cardiac arrest or death from arrhythmia (12 vs. 56 ; RR 0.24, 95% CI 0.13 to 0.45)
Conclusion
In patients with coronary artery disease, an LVEF of ≤ 40%, and asymptomatic, unsustained VT in whom sustained ventricular tachyarrhythmias were induced by programmed stimuation, antiarrhythmic therapy was superior to no antiarrhythmic therapy with respect to cardiac arrest or death from arrhythmia.
Reference
Buxton AE, Lee KL, Fisher JD et al. A randomized study of the prevention of sudden death in patients with coronary artery disease. Multicenter Unsustained Tachycardia Trial Investigators. N Engl J Med. 1999 Dec 16;341(25):1882-90.
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