Use of Direct Oral Anticoagulants in Children and Adolescents

Albisetti, Manuela

doi:10.1055/s-0039-3400491

Cited by 20 publications

(18 citation statements)

References 36 publications

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“…Another trial assessed the safety and efficacy of rivaroxaban in central venous thrombosis compared with standard of care, and no differences were evident between the two treatments in recurrences and bleeding risks [121]. Trials in pediatric populations evaluating the safety and efficacy of other factor Xa inhibitors (edoxaban and apixaban) are also ongoing [122][123][124][125].…”

Section: Direct Oral Anticoagulantsmentioning

confidence: 99%

Managing Antiphospholipid Syndrome in Children and Adolescents: Current and Future Prospects

et al. 2021

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Pediatric antiphospholipid syndrome (APS) is a rare acquired multisystem autoimmune thromboinflammatory condition characterized by thrombotic and non-thrombotic clinical manifestations. APS in children and adolescents typically presents with large-vessel thrombosis, thrombotic microangiopathy, and, rarely, obstetric morbidity. Non-thrombotic clinical manifestations are frequently seen in pediatric APS and may be present even before the vascular thrombotic events occur. We review insights into the pathogenesis of APS and discuss potential targets for therapy. The identification of multiple immunologic abnormalities in patients with APS reveals molecular targets for current or future treatment. Management strategies, especially for APS in adolescents, require screening for additional prothrombotic risk factors and consideration of counseling regarding contraceptive strategies, lifestyle recommendations, treatment adherence, and mental health issues associated with this autoimmune thrombophilia. The main goal of therapy in pediatric APS is the prevention of thrombosis. The management of acute thrombosis events in children and adolescents is the same as for primary APS, which involves isolated occurrences, and secondary APS, which is seen in association with another autoimmune disease, e.g., systemic lupus erythematosus. A pediatric hematologist should be consulted so other differential thrombophilic conditions can be eliminated. Therapy includes unfractionated heparin or low-molecular-weight heparin followed by vitamin K antagonists. Treatment of catastrophic APS involves triple therapy (anticoagulation, intravenous corticosteroid pulse therapy, and plasma exchange) and may include intravenous immunoglobulin for children and adolescents with this condition. New drugs such as eculizumab and sirolimus seem to be promising drugs for APS.

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Section: Direct Oral Anticoagulantsmentioning

confidence: 99%

Managing Antiphospholipid Syndrome in Children and Adolescents: Current and Future Prospects

et al. 2021

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“…This important field is discussed by Dr Albisetti. 7 Similarly, oral anticoagulant therapy in geriatric patients remains a challenge in daily practice. Drs Herold and Bauersachs point out pitfalls and areas of uncertainty in treating this constantly growing patient population.…”

Section: Dear Colleaguesmentioning

confidence: 99%

64th Annual Congress of the Gesellschaft für Thrombose- und Hämostaseforschung e.V. in Bremen

Renné¹

2020

Hamostaseologie

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“…Direct oral anticoagulants can be administered orally, are antithrombin independent, have a rapid onset and offset of action, few drug and food interactions, and predictable pharmacokinetics with no need of routine monitoring of anticoagulation activity. 17 Recently, two phase 3 direct oral anticoagulant trials for paediatric venous thromboembolism have been published. 18,19 The rivaroxaban phase 3 study showed that rivaroxaban was as safe and effective as standard anticoagulants in children with venous thromboembolism.…”

mentioning

confidence: 99%

ENNOBLE-ATE trial: an open-label, randomised, multi-centre, observational study of edoxaban for children with cardiac diseases at risk of thromboembolism

et al. 2021

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Children with cardiac diseases suffer from significant morbidity and mortality secondary to thromboembolic complications. Anticoagulant agents currently used for thromboprophylaxis have many limitations, including subcutaneous administration (low molecular weight heparins) and requirement for frequent monitoring via venipuncture (vitamin K antagonists). Edoxaban is an oral direct factor Xa inhibitor without need of monitoring. In the treatment of venous thromboembolism in adults, edoxaban has shown to be effective and safe. This manuscript summarises the rationale and design of a phase 3, open-label, randomised controlled trial to evaluate and compare the safety and efficacy of edoxaban against standard of care (namely, vitamin K antagonist and low molecular weight heparin) in children with cardiac diseases. A goal of 150 children with cardiac diseases at risk of thromboembolic complications who need primary or secondary anticoagulant prophylaxis will be recruited. Eligible children between 6 months and <18 years of age will be randomised in a ratio of 2 to 1 for edoxaban versus standard of care. Randomisation will be stratified based on underlying cardiac disease and concomitant use of aspirin for patients other than Kawasaki disease. The primary outcome will be safety, comprised of major and clinically relevant non-major bleeding in first 3 months of treatment. Bleeding beyond 3 months, symptomatic and asymptomatic thromboembolic events, and pharmacokinetic and pharmacodynamic parameters will be evaluated as secondary outcomes. Randomised controlled anticoagulation trials are challenging in children. This study will evaluate a potentially valuable alternative of oral anticoagulant prophylactic use in children with cardiac diseases.

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Use of Direct Oral Anticoagulants in Children and Adolescents

Cited by 20 publications

References 36 publications

Managing Antiphospholipid Syndrome in Children and Adolescents: Current and Future Prospects

Managing Antiphospholipid Syndrome in Children and Adolescents: Current and Future Prospects

64th Annual Congress of the Gesellschaft für Thrombose- und Hämostaseforschung e.V. in Bremen

ENNOBLE-ATE trial: an open-label, randomised, multi-centre, observational study of edoxaban for children with cardiac diseases at risk of thromboembolism

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