Efficacy and Safety of Dabigatran in the Treatment and Secondary Prevention of Venous Thromboembolism in Children with Central Line or Implantable Device–related Thrombosis

M. Albisetti¹, I. Tartakovsky², J. Halton³, L. Bomgaars⁴, E. Chalmers⁵, L. Mitchell⁶, M. Luciani⁷, I. Nurmeev⁸, K. Gorbatikov⁹, I. Gergei^2,10, E. Kleine¹¹, M. Brueckmann^2,10, L. Brandão^12,13

¹Hematology Department, University Children’s Hospital, Zürich, Switzerland, ²Boehringer Ingelheim International GmbH, Ingelheim, Germany, ³Children’s Hospital of Eastern Ontario, University of Ottawa, Ottawa, Canada, ⁴Department of Pediatrics, Texas Children’s Cancer Center, Baylor College of Medicine, Houston, United States, ⁵Royal Hospital for Children, Glasgow, United Kingdom, ⁶University of Alberta, Edmonton, Canada, ⁷Pediatric Hematology/Oncology Department, Pediatric Hospital Bambino Gesù, Rome, Italy, ⁸Pediatric Hospital, Republic of Tatarstan, Kazan Medical University, Kazan, Russian Federation, ⁹Pediatric Cardiovascular Surgery, Regional Hospital #1, Tyumen region, Russian Federation, ¹⁰Faculty of Medicine Mannheim of the University of Heidelberg, Mannheim, Germany, ¹¹Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. K.G., Ingelheim, Germany, ¹²The Hospital for Sick Children, University of Toronto, Toronto, Canada, ¹³Dalla Lana School of Public Health, University of Toronto, Toronto, United States

Abstract Number: OC 69.2

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. Further data on efficacy/safety of DE in the subgroup of children with a central venous catheter (CVC) or implantable device (ID) are of interest.

Aims: Subgroup analyses evaluating treatment of CVC/ID-related thrombosis and secondary VTE prophylaxis in children with continued CVC/ID use.

Methods: DIVERSITY trial: children (birth to <18 years) 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/VTE-related death. Secondary VTE prevention trial: children (>3 months to <18 years) with continued CVC/ID use received DE for up to 12 months. Eligible children had previous VTE treatment with SOC for ≥3 months or had completed either treatment in DIVERSITY. Primary endpoints: VTE recurrence and bleeding events (BEs).

Results: In DIVERSITY, 58 children (21.7%) had CVC/ID-related thrombosis. They were younger than the subgroup without CVC/ID thrombosis (mean 5.7 vs. 12.4 years for the DE cohort; mean 5.3 vs. 13.1 years for the SOC cohort). In those with CVC/ID thrombosis, 67.6% treated with DE versus 66.7% treated with SOC achieved the primary endpoint, whereas 40.6% versus 33.3%, respectively, met the primary endpoint in the non-CVC/ID subgroup (Table 1). In the secondary prevention trial, no recurrent VTE occurred in the 14 patients with CVC/ID (Table 2). Rates of major/clinically relevant nonmajor (CRNM) BEs were low.

Conclusions: In a cohort of children with CVC/ID-related VTE we found similar rates of efficacy endpoints with DE or SOC. Children with continued CVC/ID use and DE for secondary VTE prevention had no VTE recurrence and low rates of major and CRNM BEs.

Table 1: Acute VTE treatment trial: outcomes for CVC/ID* thrombosis subgroup analysis

Table 2: Secondary VTE prevention trial: outcomes for continued CVC/ID* use subgroup analysis

To cite this abstract in AMA style:

Albisetti M, Tartakovsky I, Halton J, Bomgaars L, Chalmers E, Mitchell L, Luciani M, Nurmeev I, Gorbatikov K, Gergei I, Kleine E, Brueckmann M, Brandão L. Efficacy and Safety of Dabigatran in the Treatment and Secondary Prevention of Venous Thromboembolism in Children with Central Line or Implantable Device–related 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-central-line-or-implantable-device-related-thrombosis/. Accessed December 7, 2021.

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