PB0619 - Safety and Efficacy of Direct Oral Anticoagulants for Treatment of Venous Thromboembolism in Pediatric Patients: a Single Centre Experience

Background: Recently, the role of DOACs in the therapy of pediatric patients has been significantly expanded. Despite the promising results of clinical trials, we considered that further studies aimed at evaluating the efficacy and safety of these drugs in children and adolescents are still essential.

Aims: To evaluate the safety and efficacy of the use of DOAC in children.

Methods: The study was a retrospective monocenter study. Case histories of inpatients and outpatients aged 0 to 17 years receiving apixaban, rivaroxaban or dabigatran were analyzed. Exclusion criteria were arterial thrombosis, DOAC therapy for less than 14 days, combined anticoagulant therapy, and failure to follow-up. The incidence of retrombosis and bleeding was assessed.

Results: During the period 2013-2022, 67 patients receiving DOAC were followed up at the Dmitry Rogachev National Research Center. The patients were divided into 2 groups: Group 1 - 6 patients receiving DOAC as primary prophylactic anticoagulant therapy, and Group 2 - 61 patients receiving DOAC as secondary antithrombotic prophylaxis after deep vein thrombosis. The median follow-up time was 46 (25-365) days in group 1 and 120 (14-1100) days in group 2. There were no episodes of venous thromboembolism (VTE) in group 1, and 1 (16.7%) minor bleeding was reported; group 2 had 1 (2%) major and 4 (6%) minor bleeding. Four (6 %) patients in group 2 had recurrences of VTE.

Conclusion(s): The majority of patients in this study received rivaroxaban (82%). We found a moderately increased rate of VTE recurrences, which could be the result of a longer follow-up period, and a comparable rate of bleeding, all of which were associated with rivaroxaban therapy. Prospective studies of DOAC use as primary and secondary antithrombotic prophylaxis in pediatric patients are of significant clinical interest.