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  1. Home
  3. Effect Of Anticoagulant Therapy For 6 Weeks Vs 3 Months On Recurrence And Bleeding Events In Patients Younger Than 21 Years Of Age With Provoked Venous Thromboembolism: The Kids-dott Randomized Clinical Trial.
  1. Home
  3. Effect Of Anticoagulant Therapy For 6 Weeks Vs 3 Months On Recurrence And Bleeding Events In Patients Younger Than 21 Years Of Age With Provoked Venous Thromboembolism: The Kids-dott Randomized Clinical Trial.

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Effect of Anticoagulant Therapy for 6 Weeks vs 3 Months on Recurrence and Bleeding Events in Patients Younger Than 21

Neil A Goldenberg1,2,3, John M Kittelson4,5, Thomas C Abshire6

  • 1Institute for Clinical and Translational Research, Cancer and Blood Disorder Institute, and Heart Institute, Johns Hopkins All Children's Hospital, St Petersburg, Florida.

JAMA
|January 11, 2022

View abstract on PubMed

Summary
This summary is machine-generated.

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For children and adolescents with provoked venous thromboembolism, a 6-week anticoagulant therapy duration is as safe and effective as a 3-month duration. This shorter treatment reduces bleeding risk without increasing recurrence risk.

Area of Science:

  • Pediatric Hematology
  • Cardiovascular Medicine
  • Clinical Trials

Background:

  • Optimal anticoagulant therapy duration for pediatric venous thromboembolism (VTE) is not well-established.
  • Provoked VTE in patients under 21 years requires further investigation regarding treatment length.

Purpose of the Study:

  • To determine if 6-week anticoagulant therapy is noninferior to 3-month therapy for provoked VTE in patients younger than 21 years.
  • To evaluate the trade-off between recurrent VTE and bleeding events with different anticoagulant durations.

Main Methods:

  • A randomized clinical trial involving 417 pediatric patients with acute, provoked VTE across 42 international centers.
  • Patients were randomized to either 6 weeks or 3 months of anticoagulant therapy.
  • Primary outcomes included symptomatic recurrent VTE and clinically relevant bleeding events within 1 year, with noninferiority analysis in the per-protocol population.

Main Results:

  • Noninferiority was demonstrated, with 1-year cumulative incidence of recurrent VTE at 0.66% for 6 weeks vs 0.70% for 3 months.
  • Clinically relevant bleeding incidence was 0.65% for 6 weeks vs 0.70% for 3 months.
  • Fewer adverse events were observed in the 6-week group (26%) compared to the 3-month group (32%).

Conclusions:

  • Six-week anticoagulant therapy for provoked VTE in patients under 21 years is noninferior to 3-month therapy.
  • Shorter duration therapy demonstrated a favorable balance between VTE recurrence and bleeding risk.
  • These findings support shorter anticoagulant treatment durations in pediatric provoked VTE.