Among pediatric patients with cerebral venous thrombosis (CVT), those treated with rivaroxaban or standard anticoagulants had a lower risk of both venous thromboembolism (VTE) and bleeding, according to a predefined subgroup analysis published in Blood Advances.
CVT, which occurs in about 0.7 per 100,000 pediatric patients annually, poses a serious risk if left untreated, and is associated with severe headache, problems with vision, seizure, focal neurologic deficits, and death. Risk factors for CVT include birth complications, infection, cancer, traumatic head injury, thrombophilia, and hormonal contraceptive–use.
While anticoagulant therapy is widely used in this setting, there is scant published support for its use. Recently, a phase 3 trial suggested that anticoagulant therapy, as well as rivaroxaban, a direct factor Xa inhibitor, appear to be safe and effective among pediatric patients presenting with VTE. For this subgroup analysis, researchers evaluated the safety and efficacy of rivaroxaban and standard anticoagulation among those who presented with CVT in the larger study.
Overall, 114 pediatric patients with confirmed CVT were randomly assigned to receive rivaroxaban (73 patients) or standard anticoagulation (41 patients). In the rivaroxaban and standard anticoagulation groups, 46 patients (63%) and 23 patients (56%) were male, respectively, and 51 patients (70%) and 30 patients (73%) presented with headache; the largest age group in all cohorts was 6 to 11 years.
After 3 months, 0 patients in the rivaroxaban group and 1 patient (2.4%) in the standard anticoagulant group had symptomatic and recurrent VTE. Clinically relevant bleeding was noted in 5 patients (6.8%) in the rivaroxaban group and 1 patient (2.5%) in the standard anticoagulation group. The bleeding events were nonmajor and noncerebral in the rivaroxaban group; however, the 1 case in the standard anticoagulation group was considered major.
In the rivaroxaban group, 18 patients (25%) and 39 patients (53%) had complete and partial sinus recanalization, respectively, compared with 6 patients (15%) and 24 patients (59%) in the standard anticoagulation group.
“In summary, most children with acute CVT had favorable clinical outcomes,” the authors wrote. “Both rivaroxaban and standard anticoagulants were associated with low risks of recurrent thrombosis and major bleeding.”
Disclosure: Some authors have declared affiliations with or received funding from the pharmaceutical industry. Please refer to the original study for a full list of disclosures.
Connor P, Sánchez van Kammen M, Lensing AWA, et al for the EINSTEIN-Jr Cerebral Venous Thrombosis trial investigation. Safety and efficacy of rivaroxaban in pediatric cerebral venous thrombosis (EINSTEIN-Jr CVT). Blood Adv. 2020;4(24):6250-8. doi:10.1182/bloodadvances.2020003244