Thromboprophylaxis for Children Post‐Fontan Procedure: Insights From the UNIVERSE Study

Background Patients with single‐ventricle physiology who undergo the Fontan procedure are at risk for thrombotic events associated with significant morbidity and mortality. The UNIVERSE Study evaluated the efficacy and safety of a novel liquid rivaroxaban formulation, using a body weight–adjusted do...

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Autores principales:	Brian W. McCrindle, Alan D. Michelson, Andrew H. Van Bergen, Estela Suzana Horowitz, Juan Pablo Sandoval, Henri Justino, Kevin C. Harris, John L. Jefferies, Liza Miriam Pina, Colleen Peluso, Kimberly Nessel, Wentao Lu, Jennifer S. Li
Formato:	article
Lenguaje:	EN
Publicado:	Wiley 2021
Materias:	children Fontan major bleeding rivaroxaban thrombotic events Diseases of the circulatory (Cardiovascular) system RC666-701
Acceso en línea:	https://doaj.org/article/de980047a9544d9ca47211e41db285b2
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spelling	oai:doaj.org-article:de980047a9544d9ca47211e41db285b22021-11-16T10:22:43ZThromboprophylaxis for Children Post‐Fontan Procedure: Insights From the UNIVERSE Study10.1161/JAHA.120.0217652047-9980https://doaj.org/article/de980047a9544d9ca47211e41db285b22021-11-01T00:00:00Zhttps://www.ahajournals.org/doi/10.1161/JAHA.120.021765https://doaj.org/toc/2047-9980Background Patients with single‐ventricle physiology who undergo the Fontan procedure are at risk for thrombotic events associated with significant morbidity and mortality. The UNIVERSE Study evaluated the efficacy and safety of a novel liquid rivaroxaban formulation, using a body weight–adjusted dosing regimen, versus acetylsalicylic acid (ASA) in children post‐Fontan. Methods and Results The UNIVERSE Study was a randomized, multicenter, 2‐part, open‐label study of rivaroxaban, in children who had undergone a Fontan procedure, to evaluate its dosing regimen, safety, and efficacy. Part A was the single‐arm part of the study that determined the pharmacokinetics/pharmacodynamics and safety of rivaroxaban in 12 participants before proceeding to part B, whereby 100 participants were randomized 2:1 to open‐label rivaroxaban versus ASA. The study period was 12 months. A total of 112 participants were enrolled across 35 sites in 10 countries. In part B, for safety outcomes, major bleeding occurred in one participant on rivaroxaban (epistaxis that required transfusion). Clinically relevant nonmajor bleeding occurred in 6% of participants on rivaroxaban versus 9% on ASA. Trivial bleeding occurred in 33% of participants on rivaroxaban versus 35% on ASA. For efficacy outcomes, 1 participant on rivaroxaban in part B had a pulmonary embolism (2% overall event rate); and for ASA, 1 participant had ischemic stroke and 2 had venous thrombosis (9% overall event rate). Conclusions In this study, participants who received rivaroxaban for thromboprophylaxis had a similar safety profile and fewer thrombotic events, albeit not statistically significant, compared with those in the ASA group. Registration URL: https://www.clinicaltrials.gov. Identifier: NCT02846532.Brian W. McCrindleAlan D. MichelsonAndrew H. Van BergenEstela Suzana HorowitzJuan Pablo SandovalHenri JustinoKevin C. HarrisJohn L. JefferiesLiza Miriam PinaColleen PelusoKimberly NesselWentao LuJennifer S. LiWileyarticlechildrenFontanmajor bleedingrivaroxabanthrombotic eventsDiseases of the circulatory (Cardiovascular) systemRC666-701ENJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease, Vol 10, Iss 22 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	children Fontan major bleeding rivaroxaban thrombotic events Diseases of the circulatory (Cardiovascular) system RC666-701
spellingShingle	children Fontan major bleeding rivaroxaban thrombotic events Diseases of the circulatory (Cardiovascular) system RC666-701 Brian W. McCrindle Alan D. Michelson Andrew H. Van Bergen Estela Suzana Horowitz Juan Pablo Sandoval Henri Justino Kevin C. Harris John L. Jefferies Liza Miriam Pina Colleen Peluso Kimberly Nessel Wentao Lu Jennifer S. Li Thromboprophylaxis for Children Post‐Fontan Procedure: Insights From the UNIVERSE Study
description	Background Patients with single‐ventricle physiology who undergo the Fontan procedure are at risk for thrombotic events associated with significant morbidity and mortality. The UNIVERSE Study evaluated the efficacy and safety of a novel liquid rivaroxaban formulation, using a body weight–adjusted dosing regimen, versus acetylsalicylic acid (ASA) in children post‐Fontan. Methods and Results The UNIVERSE Study was a randomized, multicenter, 2‐part, open‐label study of rivaroxaban, in children who had undergone a Fontan procedure, to evaluate its dosing regimen, safety, and efficacy. Part A was the single‐arm part of the study that determined the pharmacokinetics/pharmacodynamics and safety of rivaroxaban in 12 participants before proceeding to part B, whereby 100 participants were randomized 2:1 to open‐label rivaroxaban versus ASA. The study period was 12 months. A total of 112 participants were enrolled across 35 sites in 10 countries. In part B, for safety outcomes, major bleeding occurred in one participant on rivaroxaban (epistaxis that required transfusion). Clinically relevant nonmajor bleeding occurred in 6% of participants on rivaroxaban versus 9% on ASA. Trivial bleeding occurred in 33% of participants on rivaroxaban versus 35% on ASA. For efficacy outcomes, 1 participant on rivaroxaban in part B had a pulmonary embolism (2% overall event rate); and for ASA, 1 participant had ischemic stroke and 2 had venous thrombosis (9% overall event rate). Conclusions In this study, participants who received rivaroxaban for thromboprophylaxis had a similar safety profile and fewer thrombotic events, albeit not statistically significant, compared with those in the ASA group. Registration URL: https://www.clinicaltrials.gov. Identifier: NCT02846532.
format	article
author	Brian W. McCrindle Alan D. Michelson Andrew H. Van Bergen Estela Suzana Horowitz Juan Pablo Sandoval Henri Justino Kevin C. Harris John L. Jefferies Liza Miriam Pina Colleen Peluso Kimberly Nessel Wentao Lu Jennifer S. Li
author_facet	Brian W. McCrindle Alan D. Michelson Andrew H. Van Bergen Estela Suzana Horowitz Juan Pablo Sandoval Henri Justino Kevin C. Harris John L. Jefferies Liza Miriam Pina Colleen Peluso Kimberly Nessel Wentao Lu Jennifer S. Li
author_sort	Brian W. McCrindle
title	Thromboprophylaxis for Children Post‐Fontan Procedure: Insights From the UNIVERSE Study
title_short	Thromboprophylaxis for Children Post‐Fontan Procedure: Insights From the UNIVERSE Study
title_full	Thromboprophylaxis for Children Post‐Fontan Procedure: Insights From the UNIVERSE Study
title_fullStr	Thromboprophylaxis for Children Post‐Fontan Procedure: Insights From the UNIVERSE Study
title_full_unstemmed	Thromboprophylaxis for Children Post‐Fontan Procedure: Insights From the UNIVERSE Study
title_sort	thromboprophylaxis for children post‐fontan procedure: insights from the universe study
publisher	Wiley
publishDate	2021
url	https://doaj.org/article/de980047a9544d9ca47211e41db285b2
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Thromboprophylaxis for Children Post‐Fontan Procedure: Insights From the UNIVERSE Study

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