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

Manuela Albisetti, M.D.
University Children’s Hospital
Zurich, Switzerland

On Wednesday, July 21, 2021, Manuela Albisetti, Head of the Hemophilia Center of the University Children’s Hospital in Zurich, Switzerland, presented results from research that looked at the efficacy and safety of dabigatran in treatment and secondary prevention of venous thromboembolism (VTE) in children with central venous catheter (CVC)- or implantable device (ID)-related thrombosis. Evidence to date demonstrates the effectiveness of dabigatran for acute VTE, and a relatively favorable safety profile in secondary VTE prevention in children.

The DIVERSITY trial, a large phase 2b/3 pediatric study, was done to assess the efficacy and safety of dabigatran relative to standard of care and to document the appropriateness of the proposed dabigatran dosing algorithm for use in patients from birth to less than 18 years of age. Albisetti had commented that with this particular study, there was a hyper focus on complete thrombus resolution and freedom from VTE recurrence/VTE-related death and bleeding events. What was observed in this analysis was that for a specific cohort of children with CVC-/ID-related VTE, similar rates of efficacy endpoints were achieved with either dabigatran or standard of care. Children with continued CVC/ID use and dabigatran for secondary VTE prevention had no VTE recurrence and low rates of major and clinically relevant nonmajor bleeding.
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