Safety and efficacy of anticoagulant therapy in pediatric catheter-related venous thrombosis (EINSTEIN-Jr CVC-VTE).
Thom K, Lensing AWA, Nurmeev I, Bajolle F, Bonnet D, Kenet G, Massicotte MP, Karakas Z, Palumbo JS, Saracco P, Amedro P, Chain J, Chan AK, Ikeyama T, Lam JCM, Gauger C, Pap ÁF, Majumder M, Kubitza D, Smith WT, Berkowitz SD, Prins MH, Monagle P, Young G, Male C.
Blood Adv. 2020 Oct 13;4(19):4632-4639. doi: 10.1182/bloodadvances.2020002637
Take Home Points:
- Both rivaroxaban and standard anticoagulants (heparin and vitamin K antagonists) seem to be a safe treatment for children with central venous catheter related venous thromboembolism (CVC-VTE).
- Persistent need of the CVC and residual venous thromboembolism in children younger than 2 years were associated with continuation of anticoagulant therapy beyond the study period.
Commentary from Dr. Inga Voges (Kiel, Germany), section editor of Pediatric/Fetal Cardiology Journal Watch: The EINSTEIN-Jr study compared rivaroxaban to standard anticoagulants in 500 children of all ages for treatment of acute venous thromboembolism (VTE) of any type. Pediatric patients were randomized in a 2:1 ratio to rivaroxaban or comparator (heparin or vitamin K antagonist).
In this subanalysis of the EINSTEIN-Jr study the authors analyzed the safety of anticoagulation and the clinical risk profile and characteristics of children with central venous catheter (CVC) related thromboembolism (CVC-VTE). They also evaluated if the risk factor profile affects the duration of anticoagulant treatment. Children with CVC-VTE were included if they were treated with unfractionated heparin, low-molecular weight heparin or fondaparinux.
CVC-related, non–CVC-related recurrent deep VTE or other venous thrombosis as well as major or clinically relevant non-major bleeding were documented. In patients with no symptomatic recurrent VTE repeated imaging was performed and compared to baseline to assess vein recanalization.
Overall, 126 patients with CVC-VTE were included (Figure 1). 90 patients received rivaroxaban and 36 were treated with standard anticoagulants. 76 patients were symptomatic, and 50 patients had asymptomatic CVC-VTE. Clinically significant venous thrombosis occurred in 2 children and 3 children on rivaroxaban were diagnosed with clinically relevant non-major bleeding (Table 2). 103 patients received a repeat imaging test. Complete vein recanalization was found in 55%, incomplete recanalization in 37%, no change in 6,8% and asymptomatic deterioration in 1% of the patients.
Residual VTE on repeat imaging (limited to children younger than 2 years) and presence of a CVC at the end of the study were associated with continued anticoagulant therapy beyond the study period.
Although the sample size was small, the authors were able to demonstrate the safety of rivaroxaban and standard anticoagulant medication in patients with CVC-VTE. However, the authors also mention that larger multicenter studies are needed.