In pediatric cerebral vein thrombosis (CVT) patients, those treated with rivaroxaban or standard anticoagulants had a lower risk of 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. It is associated with severe headaches, visual disturbances, seizures, focal neurological deficits, and death. Risk factors for CVT include birth complications, infections, cancer, traumatic head injuries, thrombophilia, and hormonal contraceptives.
While anticoagulation therapy is widespread in this setting, there is little published support for its use. Recently, a phase 3 study showed that anticoagulation therapy and rivaroxaban, a direct factor Xa inhibitor, appear safe and effective in pediatric patients with VTE. For this subgroup analysis, the researchers evaluated the safety and effectiveness of rivaroxaban and standard anticoagulation in those who presented CVT in the larger study.
A total of 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, and 51 patients (70%) and 30 patients (73%) had 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 not major and not cerebral in the rivaroxaban group; However, case 1 in the standard anticoagulation group was considered severe.
In the rivaroxaban group, 18 patients (25%) and 39 patients (53%) had complete or partial recanalization of the paranasal sinuses, 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 a low risk of recurrent thrombosis and major bleeding.”
Disclosure: Some authors have declared their affiliation with the pharmaceutical industry or received funding from it. For a full list of information, see the original study.
Connor P, Sánchez van Kammen M, Lensing AWA et al. For the investigation of the EINSTEIN-Jr Cerebral Venous Thrombosis Study. Safety and efficacy of rivaroxaban in pediatric cerebral vein thrombosis (EINSTEIN-Jr CVT). Blood Adv. 2020; 4 (24): 6250- 8. doi: 10.1182 / bloodadvances.2020003244
This article originally appeared on Hematology Advisor