Journal article

A Multicenter, Randomized Trial Comparing Heparin/Warfarin and Acetylsalicylic Acid as Primary Thromboprophylaxis for 2 Years After the Fontan Procedure in Children

Paul Monagle, Andrew Cochrane, Robin Roberts, Cedric Manlhiot, Robert Weintraub, Barbara Szechtman, Marina Hughes, Maureen Andrew, Brian W McCrindle

Journal of the American College of Cardiology | ELSEVIER SCIENCE INC | Published : 2011


OBJECTIVES: The purpose of this study was to compare the safety and efficacy of acetylsalicylic acid (ASA) and warfarin for thromboprophylaxis after the Fontan procedure. BACKGROUND: Fontan surgery is the definitive palliation for children with single-ventricle physiology. Thrombosis is an important complication; the optimal thromboprophylaxis strategy has not been determined. METHODS: We performed a multicenter international randomized trial of primary prophylactic anticoagulation after Fontan surgery. Patients were randomized to receive for 2 years either ASA (5 mg/kg/day, no heparin phase) or warfarin (started within 24 h of heparin lead-in; target international normalized ratio: 2.0 to 3..

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Awarded by Heart and Stroke Foundation of Ontario

Funding Acknowledgements

This work was supported by a research grant from the Heart and Stroke Foundation of Ontario (grant-in-aid NA-3565), National Heart Foundation of Australia project grant, the Henderson Research Centre, Hamilton, and the CIBC World Markets Children's Miracle Foundation Endowed Chair in Child Health Research. Presented at the 2008 Scientific Sessions of the American Heart Association, November 8-12, 2008, New Orleans, Louisiana. Dr. McCrindle has served as a consultant to Bristol-Myers Squibb, Daiichi Sankyo, and Merck; and has received research support from Schering-Plough and AstraZeneca. All other authors have reported that they have no relationships to disclose. Dr. Andrew is deceased.