Safety and efficacy of rivaroxaban in pediatric cerebral venous thrombosis (EINSTEIN-Jr CVT)

Content Provider	Scilit
Author	Connor, Philip Kammen, Mayte Sánchez Van Lensing, Anthonie W. A. Chalmers, Elizabeth Kállay, Krisztián Hege, Kerry Simioni, Paolo Biss, Tina Bajolle, Fanny Bonnet, Damien Grunt, Sebastian Kumar, Riten Lvova, Olga Bhat, Rukhmi Damme, An Van Palumbo, Joseph Santamaria, Amparo Saracco, Paola Payne, Jeanette Baird, Susan Godder, Kamar Labarque, Veerle Male, Christoph Martinelli, Ida Soto, Michelle Morales Motwani, Jayashree Shah, Sanjay Hooimeijer, Helene L. Prins, Martin H. Kubitza, Dagmar Smith, William T. Berkowitz, Scott D. Pap, Akos F. Majumder, Madhurima Monagle, Paul Coutinho, Jonathan M.
Copyright Year	2020
Description	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], −2.6% 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, −6.7% 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.
Related Links	https://ashpublications.org/bloodadvances/article-pdf/4/24/6250/1795575/advancesadv2020003244.pdf
Ending Page	6258
Page Count	9
Starting Page	6250
DOI	10.1182/bloodadvances.2020003244
Journal	Blood advances
Issue Number	24
Volume Number	4
Language	English
Publisher	American Society of Hematology
Publisher Date	2020-12-22
Access Restriction	Open
Subject Keyword	Hematology Safety Children Treatment Efficacy Cvt Standard Anticoagulant Rivaroxaban Or Standard Journal: Blood advances (Vol- 138, Issue- 24)
Content Type	Text
Resource Type	Article