The study of antiarrhythmic medications in infancy (SAMIS): a multicenter, randomized controlled trial comparing the efficacy and safety of digoxin versus propranolol for prophylaxis of supraventricular tachycardia in infants.
Document Type
Article
Publication Date
10-2012
Identifier
DOI: 10.1161/CIRCEP.112.972620
Abstract
BACKGROUND: Supraventricular tachycardia (SVT) is one of the most common conditions requiring emergent cardiac care in children, yet its management has never been subjected to a randomized controlled clinical trial. The purpose of this study was to compare the efficacy and safety of the 2 most commonly used medications for antiarrhythmic prophylaxis of SVT in infants: digoxin and propranolol.
METHODS AND RESULTS: This was a randomized, double-blind, multicenter study of infants(atrioventricular reciprocating tachycardia or atrioventricular nodal reentrant tachycardia), excluding Wolff-Parkinson-White, comparing digoxin with propranolol. The primary end point was recurrence of SVT requiring medical intervention. Time to recurrence and adverse events were secondary outcomes. Sixty-one patients completed the study, 27 randomized to digoxin and 34 to propranolol. SVT recurred in 19% of patients on digoxin and 31% of patients on propranolol (P=0.25). No first recurrence occurred after 110 days of treatment. The 6-month recurrence-free status was 79% for patients on digoxin and 67% for patients on propranolol (P=0.34), and there were no first recurrences in either group between 6 and 12 months. There were no deaths and no serious adverse events related to study medication.
CONCLUSIONS: There was no difference in SVT recurrence in infants treated with digoxin versus propranolol. The current standard practice may be treating infants longer than required and indicates the need for a placebo-controlled trial. Clinical Trial Registration Information- http://clinicaltrials.gov; NCT-00390546.
Journal Title
Circ Arrhythm Electrophysiol
Volume
5
Issue
5
First Page
984
Last Page
991
MeSH Keywords
Anti-Arrhythmia Agents; Canada; Chi-Square Distribution; Digoxin; Double-Blind Method; Female; Humans; Infant; Infant, Newborn; Male; Proportional Hazards Models; Propranolol; Recurrence; Tachycardia, Supraventricular; Treatment Outcome; United States
Keywords
Anti-Arrhythmia Agents; Canada; Chi-Square Distribution; Digoxin; Double-Blind Method; Female; Humans; Infant; Infant, Newborn; Male; Proportional Hazards Models; Propranolol; Recurrence; Tachycardia, Supraventricular; Treatment Outcome; United States
Recommended Citation
Sanatani, S., Potts, J. E., Reed, J. H., Saul, J., Stephenson, E. A., Gibbs, K. A., Anderson, C. C., Mackie, A. S., Ro, P. S., Tisma-Dupanovic, S., Kanter, R. J., Batra, A. S., Fournier, A., Blaufox, A. D., Singh, H. R., Ross, B. A., Wong, K. K., Bar-Cohen, Y., McCrindle, B. W., Etheridge, S. P. The study of antiarrhythmic medications in infancy (SAMIS): a multicenter, randomized controlled trial comparing the efficacy and safety of digoxin versus propranolol for prophylaxis of supraventricular tachycardia in infants. Circ Arrhythm Electrophysiol 5, 984-991 (2012).
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