Abstract Number: OC 12.1
Meeting: ISTH 2020 Congress
Background: In children, current standard of care (SOC) with heparins or vitamin K antagonists is limited by parenteral administration and frequent monitoring. Dabigatran etexilate (DE) is an effective oral treatment of venous thromboembolism (VTE) in adults.
Aims: Evaluate DE efficacy and safety versus SOC, and the appropriateness of a DE dosing algorithm in children aged < 2 years (yrs) with VTE compared with older children (≥2yrs-< 18yrs).
Methods: This was a subgroup analysis of the open-label, randomized, active-controlled, multi-centre, phase IIb/III DIVERSITY trial (NCT01895777; consent obtained and ethics committee approved). Children (birth-< 6 months [< 6mos]; ≥6mos-< 2yrs; ≥2yrs-< 18yrs) with an objectively confirmed VTE diagnosis and initially treated with unfractionated heparin or low-molecular-weight heparin were randomized (2:1) to DE (capsules/pellets/oral suspension, using an age- and body weight-adjusted dosing algorithm) or SOC, and treated up to 3 months. Primary efficacy endpoint: VTE recurrence, VTE-related death, and complete thrombus resolution. Safety endpoints: bleeding events (BEs) and adverse events (AEs).
Results: Of 267 children in the randomized set, 35 were < 2yrs (22 received DE, 13 SOC; 14 were < 6mos [11 DE, 3 SOC]) and 232 were ≥2yrs-< 18yrs (155 DE, 77 SOC). Across all age groups (Table), DE was as effective as SOC for the combined efficacy endpoint, and the frequency of major BEs with DE and SOC was similar. The frequency of minor BEs was higher with DE in children < 2 years (event numbers were low in the two youngest age groups); in those ≥2yrs-< 18yrs, fewer BEs were observed with DE versus SOC. The frequency of serious AEs was comparable for DE versus SOC across all age groups.
Conclusions: This DIVERSITY subgroup analysis study suggests favourable efficacy and comparable safety of DE versus SOC in this vulnerable population aged < 2yrs, when dosed according to an age- and body weight-adjusted algorithm.
[Table. Efficacy and safety results of paediatric patients with VTE: Comparison of patients aged from birth-<2yrs versus ≥2yrs-<18yrs]
To cite this abstract in AMA style:Halton J, Brandão L, Luciani M, Bomgaars L, Chalmers E, Mitchell L, Nurmeev I, Sharathkumar A, Svirin P, Gorbatikov K, Tartakovsky I, Simetzberger M, Huang F, Sun Z, Kreuzer J, Gropper S, Reilly P, Brueckmann M, Albisetti M, on Behalf of the Study Investigators . Efficacy and Safety of Dabigatran Etexilate for Treatment of Venous Thromboembolism in Paediatric Patients Aged from Birth to < 2 Years - Results of the DIVERSITY Trial [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/efficacy-and-safety-of-dabigatran-etexilate-for-treatment-of-venous-thromboembolism-in-paediatric-patients-aged-from-birth-to-2-years-results-of-the-diversity-trial/. Accessed May 6, 2021.
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