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 were part of standard of care (SOC) anticoagulation for thromboembolism (TE) prophylaxis in children with heart illness. There was a paucity of information for alternative uses of direct oral anticoagulants in children. For a study, researchers sought to gather 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 three 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. Both teams might stay in the open-label edoxaban extension arm through one year. Clinically relevant bleeding (CRB) was the primary end-point. Asymptomatic intracardiac thrombosis or symptomatic TE was the primary, secondary objective.
About 167 kids were part of the modified intention-to-treat cohort. During the main period, one patient in each group developed a nonmajor CRB. As a result, 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). Around 1 CRB incident (0.7%) and 4 TEs (2.8%; 2 strokes & 2 of 33 Kawasaki disease patients with coronary artery thromboses and/or myocardial infarctions) occurred among the 147 kids in the extension.
Edoxaban was a viable substitute for warfarin in children with a heart illness who had low rates of CRB and TEs and benefited from requiring daily dosage and rarely monitoring.