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.
Author(s): Sanatani S, Potts JE, Reed JH, Saul JP, Stephenson EA, Gibbs KA, Anderson CC,
Mackie AS, Ro PS, Tisma-Dupanovic S, Kanter RJ, Batra AS, Fournier A, Blaufox AD,
Singh HR, Ross BA, Wong KK, Bar-Cohen Y, McCrindle BW, Etheridge SP.
Affiliation(s): Division of Pediatric Cardiology, British Columbia Children's Hospital,
Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada.
Publication date & source: 2012, Circ Arrhythm Electrophysiol. , 5(5):984-91
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
METHODS AND RESULTS: This was a randomized, double-blind, multicenter study of
infants <4 months with SVT (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.