Abstract Number: OC 12.2
Meeting: ISTH 2020 Congress
Background: Anticoagulant treatment of pediatric central venous catheter-related venous thromboembolism (CVC-VTE) has not been prospectively evaluated. In the EINSTEIN-Jr. trial, 500 children with any VTE were randomized to rivaroxaban or standard anticoagulants.
Aims: Predefined analysis of the CVC-VTE subgroup of the EINSTEIN-Jr. population.
Methods: Children with CVC-VTE, aged birth-17 years, received open-label rivaroxaban or standard anticoagulants (2:1 ratio) for 1 month (children < 2 years) or 3 months (all other children). Predefined study outcomes were recurrent VTE, other clinically relevant VTE, radiographic change in thrombotic burden, and bleeding. CVC-associated infections were recorded. Predictors for continuation of anticoagulation beyond the study period were evaluated by logistic regression analysis.
Results: 126 children with CVC-VTE, 50 (40%) with symptomatic VTE, received either rivaroxaban (n=90) or standard anticoagulants (n=36) for a median follow-up of 31 days (IQR 29-35; 1-month group) and 91 days (IQR 86-95; 3-month group). Recurrent VTE or major bleeding was not observed (95% confidence interval [CI], 0.0-2.8%), 3 children had clinically relevant non-major bleeding (2.4%; 95%CI, 0.7-6.5%), and 2 had clinically relevant VTE in other locations (1.6%; 95%CI, 0.3-5.4%) (table). Complete or partial vein recanalization occurred in 57 (55%) and 38 (37%) of 103 evaluable children, respectively. CVC-associated infection occurred in 3 (4.3%) of 69 children with normalized repeat imaging and in 6 (11.3%) of 53 children with residual VTE (odds ratio [OR] 0.36, 95%CI, 0.85-1.50). Anticoagulation was continued beyond the study period with residual VTE on repeat imaging (OR, 28.8; p=0.0004) in children < 2 years, continued CVC use (OR 6.8; p=0.002), and potentially with symptomatic initial CVC-VTE (OR 2.6; p=0.057).
Conclusions: In children with CVC-VTE, anticoagulation was efficacious and safe and resulted in a reduced clot burden in over 90% of children. Prolonged anticoagulation was associated with residual VTE on repeat imaging in children < 2 years, continued CVC use, and symptomatic initial CVC-VTE.
|Outcome n (%)||Rivaroxaban n=90||Standard anticoagulants n=36||Absolute risk difference (95%CI)|
|Recurrent VTE||0||0||0% (-11 to 4.2%)|
|Other clinically relevant venous thrombosis||1 (1.1)||1 (2.8)||-1.7% (-14 to 3.6%)|
|Major bleeding||0||0||0% (-11 to 4.2%)|
|Clinically relevant non-major bleeding||3 (3.3)||0||3.3% (-6.4 to 9.7%)|
|CVC related bloodstream infection||7 (7.8)||3 (8.3)||-0.6% (-10 to 11.4%)|
|Repeat VTE imaging – normalised||42 (47)||15 (42)|
|Repeat VTE imaging – improved||26 (29)||12 (33)|
|Repeat VTE imaging – unchanged||2 (2.2)||5 (14)|
|Repeat VTE imaging – deteriorated||1 (1.1)||0|
[Clinical outcomes and radiographic change in thrombus burden by treatment group]
To cite this abstract in AMA style:Thom K, Lensing AWA, Kubitza D, Pap AF, Prins MH, Kenet G, Massicotte MP, Chan AK, Monagle P, Young G, Male C, EINSTEIN Jr CVC-VTE Investigators . Safety and Efficacy of Anticoagulant Therapy in Pediatric Catheter-related Venous Thrombosis (EINSTEIN-Jr. CVC-VTE): A Pre-specified Substudy [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/safety-and-efficacy-of-anticoagulant-therapy-in-pediatric-catheter-related-venous-thrombosis-einstein-jr-cvc-vte-a-pre-specified-substudy/. Accessed September 24, 2023.
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