The following is a summary of “Edoxaban for Thromboembolism Prevention in Pediatric Patients With Cardiac Disease,” published in the December 2022 issue of Cardiology by Portman, et al.
Low molecular weight heparins or vitamin K antagonists are part of standard of care (SOC) anticoagulation for thromboembolism (TE) prophylaxis in children with heart illness. For alternative uses of direct oral anticoagulants in children, there was a paucity of information. For a study, researchers sought information on the safety and effectiveness of edoxaban in youngsters.
They conducted the ENNOBLE-ATE [Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Due to Cardiac Disease] trial, which was a phase 3 multinational prospective, randomized, open-label, blinded-endpoint trial in patients <18 years of age with cardiac disease. For 3 months (the primary trial period), patients were randomized 2:1 to once-daily oral edoxaban based on age and weight vs. SOC, stratified by cardiac diagnosis. Through one year, both teams might stay in the open-label edoxaban extension arm. The primary endpoint was adjudicated clinically relevant bleeding (CRB). Asymptomatic intracardiac thrombosis or symptomatic TE was the primary secondary objective.
Over 167 kids were part of the modified intention-to-treat cohort. During the main period, one patient in each group developed a nonmajor CRB. 46.8% (51 of 109) of edoxaban users experienced treatment-emergent adverse events, compared to 41.4% (24 of 58) of SOC users. Two TE episodes occurred in one SOC patient (DVT with PE). 1 CRB incident (0.7%) and 4 TEs (2.8%; 2 strokes and 2 of 33 Kawasaki disease patients with coronary artery thromboses &/or myocardial infarctions) occurred among the 147 children in the extension.
Edoxaban had the advantages of a once-daily dose and occasional monitoring requirements, making it a viable alternative method of thromboprophylaxis for children with heart illness.
Reference: jacc.org/doi/10.1016/j.jacc.2022.09.031
