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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 6250-6258 |
| Number of pages | 9 |
| Journal | Blood Advances |
| Volume | 4 |
| Issue number | 24 |
| DOIs | |
| State | Published - Dec 22 2020 |
Funding
Conflict-of-interest disclosure: P.C., K.K., P. Simioni, T.B., S.G., R.B., A.V.D., J. Palumbo, P. Saracco, J. Payne, S.B., K.G., V.L., I.M., M.M.S., J.M., S.S., H.L.H., P.M., and J.M.C. report fees paid to their institutions from Bayer. A.W.A.L., D.K., W.T.S., S.D.B., A.F.P. and M.M. are employees of Bayer. E.C. has received personal fees from Boehringer Ingelheim and Bristol-Myers Squibb and reports fees paid to her institution from Bayer. D.B. has received personal fees and grant support from Actelion Pharmaceuticals and Novartis and reports fees paid to his institution from Bayer. O.L. has received personal fees from Bayer and reports fees paid to her institution from Bayer, Pfizer, and Boehringer Ingelheim. C.M. has received personal fees and reports fees paid to his institution from Bayer, Bristol-Myers Squibb, and Pfizer and reports fees paid to his institution from Boehringer-Ingelheim. K.H., R.K., and A.S. have received personal fees and report fees paid to their institution from Bayer. M.H.P. has received personal fees from Bayer. M.S.v.K. and F.B. declare no competing financial interests. This study was supported by Bayer AG and Janssen Research and Development.
ASJC Scopus subject areas
- Hematology