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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
Summary
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.
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