Efficacy and safety of direct oral anticoagulants in children in real clinical practice

Abstract

Introduction. As well as standard anticoagulants, direct oral anticoagulants (DOAC) have been approved for treatment of thromboembolism in children, recently. Several clinical trials provide promising data on efficacy and safety of DOAC in children and young adults. But further studies aimed at evaluating the efficacy and safety of these drugs in children and adolescents are still needed.The aim of the study is to evaluate the safety and effectiveness of the use DOACs in children.Materials and methods. We have retrospectively analyzed the medical records of patients (0–17 years) of from 2013 to 2022 at our tertiary care Centre and selected patients, who were treated with apixaban, rivaroxaban or dabigatran for more than 14 days. Patients with arterial thrombosis, children, who were treated with combined anticoagulant therapy and those who were unable for follow-up were excluded. We assessed the rates of bleeding and recurrent venous thromboembolism (VTE).Results. There were 67 patients, who were treated with DOAC in our center. Patients were divided into 2 groups: those, who received prophylactic anticoagulation (group 1 – 6 patients), and patients, who received DOAC therapy after venous thromboembolism (group 2 – 61 patients). The median follow-up time was 46 (25–365) days in the group 1, and 4 months (2 weeks – 36 month) in the group 2. There were no VTE episodes and 1 minor bleeding in group 1, while 1 (2 %) major, 4 (6 %) minor bleeding episodes in group 2. There were 4 (6 %) patients with recurrent VTE in group 2.Conclusion. The majority of patients in this study received rivaroxaban (79 %). We found a moderately increased recurrence rate of VTE, which could be the result of a long follow-up period, and a comparable rate of bleeding, all of which were associated with rivaroxaban therapy. In the future, of particular interest, in our opinion, are prospective studies of DOACs as primary antithrombotic prophylaxis, as well as secondary prophylaxis in the highest-risk groups, and the results of an analysis of their use in real clinical practice.