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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Edoxaban for Thromboembolism Prevention in Pediatric Patients With Cardiac Disease
Journal of the American College of Cardiology, Volume 80, No. 24, Year 2022
Notification
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Description
Background: Standard of care (SOC) anticoagulation for thromboembolism (TE) prevention in children with cardiac disease includes low molecular weight heparins or vitamin K antagonists. Limited data exists for alternate use of direct oral anticoagulants in children. Objectives: The investigators aimed to obtain safety and efficacy data for edoxaban in children. Methods: We performed a phase 3, multinational, prospective, randomized, open-label, blinded-endpoint trial in patients <18 years of age with cardiac disease (ENNOBLE-ATE [Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease] trial). Patients were randomized 2:1 to age- and weight-based oral edoxaban once daily vs SOC for 3 months (main study period), stratified by cardiac diagnosis. Both groups could continue in an open-label edoxaban extension arm through 1 year. The primary endpoint was adjudicated clinically relevant bleeding (CRB). The main secondary endpoint was symptomatic TE or asymptomatic intracardiac thrombosis. Results: The modified intention-to-treat cohort included 167 children. One patient per group experienced a nonmajor CRB in the main period. Treatment-emergent adverse events occurred in 46.8% (51 of 109) with edoxaban and 41.4% (24 of 58) with SOC. One SOC patient experienced 2 TE events (DVT with PE). Among 147 children in the extension, 1 CRB event (0.7%) and 4 TEs occurred (2.8%; 2 strokes and 2 of 33 Kawasaki disease patients with coronary artery thromboses and/or myocardial infarctions). Conclusions: Edoxaban is a potential alternative mode of thromboprophylaxis in children with cardiac disease showing low rates of CRB and TEs with advantages of once daily dosing and infrequent monitoring requirement. (ENNOBLE-ATE [Edoxaban for Prevention of Blood Vessels Being Blocked by Clots] (Thrombotic Events) in Children at Risk Because of Cardiac Disease trial; NCT03395639). © 2022 American College of Cardiology Foundation
Authors & Co-Authors
Jacobs, Jeffrey Phillip
United States, Gainesville
University of Florida
Newburger, Jane W.
United States, Boston
Boston Children's Hospital
Berger, Felix
Germany, Berlin
Charité – Universitätsmedizin Berlin
Goldenberg, Neil Andrew
United States, St Petersburg
All Children's Hospital St. Petersburg
United States, Baltimore
Johns Hopkins School of Medicine
Canter, Charles E.
Unknown Affiliation
Dahdah, Nagib Salloum
Unknown Affiliation
Amédro, Pascal
Unknown Affiliation
Bonnet, Damien
Unknown Affiliation
Rimini, Alessandro
Unknown Affiliation
Patel, Jashvant
Unknown Affiliation
Bereczki, Csaba
Unknown Affiliation
Revel-Vilk, Shoshana
Unknown Affiliation
Özbek, Namik Yasar
Unknown Affiliation
Ünal, Şule
Unknown Affiliation
Patirog̈lu, Türkan E.
Unknown Affiliation
Malbora, Bariş
Unknown Affiliation
Ag̈in, Hasan
Unknown Affiliation
Karakaş, Zeynep
Unknown Affiliation
Chalmers, Elizabeth A.
Unknown Affiliation
Bu'Lock, Frances A.
Unknown Affiliation
Daubeney, Piers E.F.
Unknown Affiliation
Hamza, Hala Salah El Din
Unknown Affiliation
ElAlfy, Mohsen Saleh
Unknown Affiliation
Hassab, Hoda Mohammed Abo El Fotoh
Unknown Affiliation
Daou, Linda S.
Unknown Affiliation
Bitar, Fadi F.
Unknown Affiliation
Statistics
Citations: 10
Authors: 26
Affiliations: 7
Identifiers
Doi:
10.1016/j.jacc.2022.09.031
ISSN:
07351097
Research Areas
Health System And Policy
Maternal And Child Health
Noncommunicable Diseases
Study Design
Cohort Study