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Efficacy and Safety of Dabigatran in the Treatment and Secondary Prevention of Venous Thromboembolism in Children with Cerebral Venous and Sinus Thrombosis

1The Hospital for Sick Children, University of Toronto, Toronto, Canada, 2Dalla Lana School of Public Health, University of Toronto, Toronto, United States, 3Boehringer Ingelheim International GmbH, Ingelheim, Germany, 4University of Ottawa, Ottawa, Canada, 5Department of Pediatrics, Texas Children’s Cancer Center, Baylor College of Medicine, Houston, United States, 6Royal Hospital for Children, Glasgow, United Kingdom, 7University of Alberta, Edmonton, Canada, 8Pediatric Hematology/Oncology Department, Pediatric Hospital Bambino Gesù, Rome, Italy, 9Faculty of Medicine Mannheim of the University of Heidelberg, Mannheim, Germany, 10Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. K.G., Ingelheim, Germany, 11Hematology Department, University Children’s Hospital, Zürich, Switzerland

Abstract Number: PB0787

Meeting: ISTH 2021 Congress

Theme: Pediatrics » Thrombosis in Neonates and Children

Background: Dabigatran etexilate (DE) has shown noninferiority versus standard of care (SOC) for treatment of acute venous thromboembolism (VTE), and a favorable safety profile in secondary VTE prevention in children. Efficacy and safety of DE in children with cerebral venous and sinus thrombosis (CVST) has not yet been evaluated.

Aims: Subgroup analyses evaluating DE for treatment and secondary prophylaxis of VTE in children with CVST, from two pediatric trials.

Methods: In the DIVERSITY trial, children with objectively confirmed VTE initially treated with heparin were randomized (2:1) to receive up to 3 months of DE or SOC. Primary composite efficacy endpoint: complete thrombus resolution and freedom from VTE recurrence and VTE-related death. A secondary VTE prevention trial treated children with DE for up to 12 months. Eligible children had VTE treated with SOC for ≥3 months or had completed either treatment in DIVERSITY. Primary endpoints included VTE recurrence and bleeding events (BEs).

Results: In DIVERSITY, 26 children (9.7%) had CVST. Within this subset, 45.0% of children treated with DE versus 16.7% treated with SOC achieved the primary endpoint, whereas 45.9% versus 44.0%, respectively, met the primary endpoint in the non-CVST subgroup (Table 1). Parameters of thrombus resolution and VTE recurrence (reflecting those of the primary endpoint) and BEs are shown in Table 1. Treatment by CVST interaction was not tested statistically due to the limited sample size. In the secondary prevention trial (24 patients with CVST), there was no recurrent VTE in patients with CVST and, overall, few major/clinically relevant nonmajor BEs (Table 2).

Conclusions: These subgroup analyses, in a small cohort of children with CVST, do not appear to contradict the efficacy and safety profile of DE versus SOC for treatment of acute VTE demonstrated in the overall trial, and show a favorable safety profile of DE for secondary VTE prevention.

Table 1: Acute VTE treatment trial: outcomes for CVST subgroup analysis

Table 2: Secondary VTE prevention trial: outcomes for CVST subgroup analysis

To cite this abstract in AMA style:

Brandão L, Tartakovsky I, Halton J, Bomgaars L, Chalmers E, Mitchell L, Luciani M, Gergei I, Kleine E, Brueckmann M, Albisetti M. Efficacy and Safety of Dabigatran in the Treatment and Secondary Prevention of Venous Thromboembolism in Children with Cerebral Venous and Sinus Thrombosis [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 2). https://abstracts.isth.org/abstract/efficacy-and-safety-of-dabigatran-in-the-treatment-and-secondary-prevention-of-venous-thromboembolism-in-children-with-cerebral-venous-and-sinus-thrombosis/. Accessed May 16, 2022.

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