Please use this identifier to cite or link to this item: http://hdl.handle.net/10995/103208
Title: Safety and efficacy of rivaroxaban in pediatric cerebral venous thrombosis (Einstein-Jr CVT)
Authors: Connor, P.
van Kammen, M. S.
Lensing, A. W. A.
Chalmers, E.
Kállay, K.
Hege, K.
Simioni, P.
Biss, T.
Bajolle, F.
Bonnet, D.
Grunt, S.
Kumar, R.
Lvova, O.
Bhat, R.
van Damme, A.
Palumbo, J.
Santamaria, A.
Saracco, P.
Payne, J.
Baird, S.
Godder, K.
Labarque, V.
Male, C.
Martinelli, I.
Soto, M. M.
Motwani, J.
Shah, S.
Hooimeijer, H. L.
Prins, M. H.
Kubitza, D.
Smith, W. T.
Berkowitz, S. D.
Pap, A. F.
Majumder, M.
Monagle, P.
Coutinho, J. M.
EINSTEIN-Jr, Cerebral, Venous, Thrombosis, trial, investigators
Issue Date: 2020
Publisher: American Society of Hematology
Citation: Safety and efficacy of rivaroxaban in pediatric cerebral venous thrombosis (Einstein-Jr CVT) / P. Connor, M. S. van Kammen, A. W. A. Lensing, et al. — DOI 10.1182/bloodadvances.2020003244 // Blood Advances. — 2020. — Vol. 4. — Iss. 24. — P. 6250-6258.
Abstract: Anticoagulant treatment of pediatric cerebral venous thrombosis has not been evaluated in randomized trials. We evaluated the safety and efficacy of rivaroxaban and standard anticoagulants in the predefined subgroup of children with cerebral venous thrombosis (CVT) who participated in the EINSTEIN-Jr trial. Children with CVT were randomized (2:1), after initial heparinization, to treatment with rivaroxaban or standard anticoagulants (continued on heparin or switched to vitamin K antagonist). The main treatment period was 3 months. The primary efficacy outcome, symptomatic recurrent venous thromboembolism (VTE), and principal safety outcome, major or clinically relevant nonmajor bleeding,were centrally evaluated by blinded investigators. Sinus recanalization on repeat brain imaging was a secondary outcome. Statistical analyses were exploratory. In total, 114 children with confirmed CVT were randomized. All children completed the follow-up. None of the 73 rivaroxaban recipients and 1 (2.4%; CVT) of the 41 standard anticoagulant recipients had symptomatic, recurrent VTE after 3 months (absolute difference, 2.4%; 95% confidence interval [CI], 22.6% to 13.5%). Clinically relevant bleeding occurred in 5 (6.8%; all nonmajor and noncerebral) rivaroxaban recipients and in 1 (2.5%; major [subdural] bleeding) standard anticoagulant recipient (absolute difference, 4.4%; 95% CI, 26.7% to 13.4%). Complete or partial sinus recanalization occurred in 18 (25%) and 39 (53%) rivaroxaban recipients and in 6 (15%) and 24 (59%) standard anticoagulant recipients, respectively. In summary, in this substudy of a randomized trial with a limited sample size, children with CVT treated with rivaroxaban or standard anticoagulation had a low risk of recurrent VTE and clinically relevant bleeding. This trial was registered at clinicaltrials.gov as #NCT02234843. © 2020 by The American Society of Hematology
Keywords: ANTIVITAMIN K
FONDAPARINUX
RIVAROXABAN
ADOLESCENT
ARTICLE
BLEEDING
CEREBRAL SINUS THROMBOSIS
CHILD
CONTROLLED STUDY
DRUG EFFICACY
DRUG SAFETY
DRUG SUBSTITUTION
DRUG WITHDRAWAL
FEMALE
FOLLOW UP
FUNCTIONAL NEUROIMAGING
HEPARINIZATION
HUMAN
LOW RISK POPULATION
MAJOR CLINICAL STUDY
MALE
MULTICENTER STUDY
PATIENT PARTICIPATION
PHASE 3 CLINICAL TRIAL
PRIORITY JOURNAL
RANDOMIZED CONTROLLED TRIAL
RECANALIZATION
SAMPLE SIZE
SCHOOL CHILD
TREATMENT DURATION
TREATMENT OUTCOME
VENOUS THROMBOEMBOLISM
URI: http://hdl.handle.net/10995/103208
Access: info:eu-repo/semantics/openAccess
SCOPUS ID: 85098051228
PURE ID: 20453790
552d50c2-36ea-48f2-b2aa-0debdb0768ef
ISSN: 24739529
DOI: 10.1182/bloodadvances.2020003244
metadata.dc.description.sponsorship: This study was supported by Bayer AG and Janssen Research and Development.
Appears in Collections:Научные публикации, проиндексированные в SCOPUS и WoS CC

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