Key result
DOAC use linked to an ~8% rate of recurrent or progressive thrombosis in pediatric oncology.
Why the study?
Pivotal trials supporting DOAC approvals enrolled few children with cancer-associated thrombosis, leaving a need for observational studies to address evidence gaps.
Cohort (n=51)
Yes
In a real-world pediatric oncology cohort, DOAC use for VTE was associated with higher rates of clinically relevant bleeding and recurrent thrombosis compared to clinical trials, emphasizing the complexity of anticoagulation in this high-risk population.
Supports clinical caution with DOACs in pediatric oncology; hypothesis-generating and should not yet change practice.
Background: Pivotal, phase 3 randomized controlled trials have led to the approval of direct oral anticoagulants (DOACs) for both the management of venous thromboembolism (VTE) and thromboprophylaxis in children. However, few children with cancer-associated thrombosis were enrolled in these trials. There is consequently a need for well-designed observational studies to address current gaps in the pediatric literature. Objectives: The principal objective of this retrospective cohort study was to investigate the safety and efficacy of DOACs for both treatment and prophylaxis of cancer-associated VTE in children. Methods: Prospectively maintained databases at 2 quaternary care children's hospitals were queried for children diagnosed with cancer who received a DOAC for either treatment of VTE or thromboprophylaxis. Medical records of eligible subjects were reviewed for clinical and radiological characteristics. Results: Fifty-one patients (53% female) met eligibility. Forty-seven (92%) patients received DOACs in the setting of a VTE diagnosis (treatment and secondary thromboprophylaxis), while 4 (8%) patients received DOACs for primary thromboprophylaxis. The median age at VTE diagnosis was 14.4 years. Rivaroxaban and apixaban were used in 55% and 45% of patients, respectively. Therapeutic and prophylactic-intensity DOACs were administered in 86% and 78% of patients, respectively, with many patients receiving both. Recurrent/progressive thrombosis occurred in 4 patients (8%). Major and clinically relevant nonmajor bleeding were reported in 6% and 20% of patients, respectively. No deaths were attributed to thrombosis or anticoagulant-related bleeding. Conclusion: Rates of recurrent/progressive thrombosis and clinically relevant bleeding in our cohort of children with cancer-associated thrombosis are higher than those reported in previous studies, highlighting the importance of real-world data.
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Kumar et al. (2026) conducted a cohort in Cancer-associated venous thromboembolism (n=51). Direct oral anticoagulants (DOACs) was evaluated on Recurrent/progressive thrombosis. In a real-world cohort of pediatric oncology patients, direct oral anticoagulants resulted in an 8% rate of recurrent/progressive thrombosis, 6% major bleeding, and 20% nonmajor bleeding.
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