Abstract Number: OC 69.2
Meeting: ISTH 2021 Congress
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.
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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