Edoxaban prevents thromboembolism in children with cardiac disease
Edoxaban may be used as an alternative treatment for thromboembolism (TE) prevention in children with cardiac disease showing low rates of clinically relevant bleeding and TE, suggests a study. Some of its advantages include once-daily dosing and infrequent monitoring requirement.
A phase III, multinational, prospective, randomized, open-label, blinded-endpoint trial was conducted in patients aged <18 years with cardiac disease.
The investigators randomly assigned these children to age-and weight-based oral edoxaban once daily or standard of care for 3 months (main study period), stratified by cardiac diagnosis. Both groups could then continue in an open-label edoxaban extension arm through 1 year.
Adjudicated clinically relevant bleeding was the primary outcome, while symptomatic TE or asymptomatic intracardiac thrombosis was the secondary outcome.
A total of 167 children were included in the modified intention-to-treat cohort. One patient in each group had a nonmajor clinically relevant bleeding during the main study period.
Treatment-emergent adverse events occurred in 51 (46.8 percent) of 109 children treated with edoxaban and 24 (41.4 percent) of 58 patients who received standard of care. One patient in the latter arm experienced two TE events (deep vein thrombosis with pulmonary embolism).
Among 147 children who proceeded to the extension phase of the trial, one (0.7 percent) had clinically relevant bleeding, and four (2.8 percent) experienced TEs (two stroke and two of 33 Kawasaki disease patients with coronary artery thromboses and/or myocardial infarctions).
“Standard of care anticoagulation for TE prevention in children with cardiac disease includes low molecular weight heparins or vitamin K antagonists,” the investigators said. “Limited data exists for alternate use of direct oral anticoagulants in children.”