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. 2020 Oct 13;4(19):4632-4639.
doi: 10.1182/bloodadvances.2020002637.

Safety and efficacy of anticoagulant therapy in pediatric catheter-related venous thrombosis (EINSTEIN-Jr CVC-VTE)

Katharina Thom  1 , Anthonie W A Lensing  2 , Ildar Nurmeev  3 , Fanny Bajolle  4 , Damien Bonnet  4 , Gili Kenet  5   6 , M Patricia Massicotte  7 , Zeynep Karakas  8 , Joseph S Palumbo  9 , Paola Saracco  10 , Pascal Amedro  11 , Juan Chain  12 , Anthony K Chan  13 , Takanari Ikeyama  14 , Joyce C M Lam  15 , Cynthia Gauger  16 , Ákos Ferenc Pap  2 , Madhurima Majumder  17 , Dagmar Kubitza  2 , William T Smith  17 , Scott D Berkowitz  17 , Martin H Prins  18 , Paul Monagle  19 , Guy Young  20 , Christoph Male  1
Affiliations

Safety and efficacy of anticoagulant therapy in pediatric catheter-related venous thrombosis (EINSTEIN-Jr CVC-VTE)

Katharina Thom et al. Blood Adv. .

Abstract

Anticoagulant treatment of pediatric central venous catheter-related venous thromboembolism (CVC-VTE) has not been specifically evaluated. In EINSTEIN-Jr, 500 children with any VTE received rivaroxaban or standard anticoagulants. A predefined analysis of the CVC-VTE cohort was performed. Children with CVC-VTE (age, birth to 17 years) were administered rivaroxaban or standard anticoagulants during the 1-month (children <2 years) or 3-month (all other children) study period. Predefined outcomes were recurrent VTE, change in thrombotic burden on repeat imaging, and bleeding. Predictors for continuation of anticoagulant therapy beyond the study period were evaluated. One hundred twenty-six children with symptomatic (n = 76, 60%) or asymptomatic (n = 50, 40%) CVC-VTE received either rivaroxaban (n = 90) or standard anticoagulants (n = 36). There was no recurrent VTE (0%; 95% confidence interval [CI], 0.0%-2.8%). Three children had the principal safety outcome: none had major bleeding and 3 children had clinically relevant nonmajor bleeding (2.4%; 95% CI, 0.7%-6.5%), all in the rivaroxaban arm. Complete or partial vein recanalization occurred in 57 (55%) and 38 (37%) of 103 evaluable children, respectively. Results were similar for symptomatic and asymptomatic CVC-VTE. Continuation of anticoagulant therapy beyond the study period occurred in 61 (48%) of children and was associated with residual VTE but only in children <2 years (odds ratio [OR], 20.9; P = .003) and continued CVC use (OR, 6.7; P = .002). Anticoagulant therapy appeared safe and efficacious and was associated with reduced clot burden in most children with symptomatic or asymptomatic CVC-VTE. Residual VTE and continued CVC use were associated with extended anticoagulation. This trial was registered at www.clinicaltrials.gov as #NCT02234843.

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Conflict of interest statement

Conflict-of-interest disclosure: K.T. reports study patient fees paid to her institution from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, and Pfizer. F.B. reports fees paid to her institution from Bayer and Daiichi-Sankyo. D.B. received personal fees from Bayer, Actelion Pharmaceuticals, Janssen, Novartis, Bristol-Myers Squibb, and Abbott and fees paid to his institution from Bayer and Daiichi-Sankyo. G.K. received personal fees from Bayer, Boehringer Ingelheim, and Daiichi-Sankyo and fees paid to her institution from Pfizer. M.P.M. received personal fees from Bayer. A.K.C. received personal fees from Bayer and fees paid to his institution from Bayer, Pfizer, Daiichi Sankyo, and Bristol-Myers Squibb. M.H.P. received personal fees from Bayer AG. G.Y. received personal fees from Bayer AG, Daiichi-Sankyo, and Portola. C.M. received personal fees from Bayer AG, Bristol-Myers Squibb, and Pfizer and fees paid to his institution from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, and Pfizer. I.N., Z.K., P.A., and J.C.M.L. received fees paid to their institution from Bayer AG. A.W.A.L., A.F.P., M.M., D.K., W.T.S., and S.D.B. are employees of Bayer. The remaining authors declare no competing financial interests.

Figures

None
Graphical abstract
Figure 1.
Figure 1.
Flowchart of selection of patients for the EINSTEIN-Jr CVC-VTE substudy.
See this image and copyright information in PMC

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