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| Blood advances. pii: 474703. doi: 10.1182/bloodadvances.2020003244 |
| Safety and efficacy of rivaroxaban in pediatric cerebral venous thrombosis (EINSTEIN-Jr CVT). |
| Connor P1, Sánchez van Kammen M2, Lensing AWA3, Chalmers E4, Kállay K5, Hege K6, Simioni P7, Biss T8, Bajolle F9, Bonnet D10, Grunt S11, Kumar R12, Lvova O13, Bhat R14, Van Damme A15, Palumbo J16, Santamaria A17, Saracco P18, Payne J19, Baird S20, Godder K21, Labarque V22, Male C23, Martinelli I24, Morales Soto M25, Motwani J26, Shah S27, Hooimeijer HL28, Prins MH29, Kubitza D30, Smith WT31, Berkowitz SD32, Pap AF33, Majumder M34, Monagle P35, Coutinho JM36 |
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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], -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. |
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© 2020 by The American Society of Hematology. |
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Publikations ID: 33351120 Quelle: öffnen |
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