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Edoxaban for Thromboembolism Prevention in Pediatric Patients with Cardiac Disease

Based on results of the phase 3 (ENNOBLE-ATE) trial, edoxaban provides an alternative to standard of care (SOC) anticoagulation for thromboprophylaxis in children with cardiac disease and has the advantages of once-daily dosing and infrequent monitoring. SOC anticoagulation for thromboembolism (TE) prevention in children with cardiac disease currently includes low molecular weight heparins or vitamin K antagonists; limited data exist about the use of direct oral anticoagulants in this patient population.

The trial used an open-label, blinded-endpoint design to study age- and weight-based oral edoxaban once daily versus SOC for 3 months (main study period). The primary endpoint was adjudicated clinically relevant bleeding (CRB). “The modified intention to treat cohort included 167 children,” the researchers report. “One patient per group experienced a non-major CRB in the main period. Treatment-emergent adverse events occurred in 46.8% (51/109) with edoxaban and 41.4% (24/58) with SOC. One SOC patient experienced 2 TE events (DVT with PE). Among 147 children in the extension, one CRB event (0.7%) and 4 TEs occurred (2.8%; 2 strokes and 2/33 [Kawasaki disease] patients with coronary artery thromboses and/or myocardial infarctions).”

Source: Journal of the American College of Cardiology