Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease - ENNOBLE-ATE

Dec 06, 2022
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Daiichi Sankyo
Date Published:
12/05/2022
Original Posted Date:
12/06/2022
References

Contribution To Literature:

The ENNOBLE-ATE trial showed that edoxaban was safe for treatment of children at high risk for thromboembolism.

Description:

The goal of the trial was to evaluate edoxaban compared with standard of care anticoagulants among children at high risk for thromboembolism.

Study Design

  • Randomized
  • Parallel
  • Open-label
  • Stratified

Children with cardiac disease who were at high risk for thromboembolism were randomized to edoxaban (n = 109) vs. standard of care anticoagulants (n = 58). Standard of care anticoagulants included low molecular weight heparin and vitamin K antagonists.

  • Total number of enrollees: 167
  • Duration of follow-up: 12 months
  • Mean patient age: 8 years
  • Percentage female: 35%

Inclusion criteria:

  • Children >38 weeks to <18 years of age
  • Cardiac disease and at high risk for thromboembolism requiring ≥3 months of anticoagulant prophylaxis

Exclusion criteria:

  • Symptomatic or asymptomatic arterial or venous thromboembolism
  • Asymptomatic intracardiac thrombosis
  • Mechanical heart valve
  • Active bleeding or at high risk for bleeding

Other salient features/characteristics:

  • Fontan surgery: 44%
  • Kawasaki disease: 22%
  • Heart failure: 4%

Principal Findings:

The primary outcome, major or clinically relevant nonmajor bleeding, occurred in 0.9% of the edoxaban group vs. 1.7% of the standard of care anticoagulant group.

Secondary outcomes:

  • Thromboembolic events: 0% in the edoxaban group vs. 1.7% in the standard of care anticoagulant group
  • Treatment emergent adverse events: 46.8% in the edoxaban group vs. 41.4% in the standard of care anticoagulant group

Interpretation:

Among children at high risk for thromboembolism, edoxaban was safe. Edoxaban was associated with a low rate of clinically relevant major bleeding and thromboembolic events. Due to safety profile, once daily dosing, and no need for monitoring, edoxaban may be considered for treatment of children at high risk for thromboembolism.

References:

Portman MA, Jacobs JP, Newburger JW, et al., on behalf of the ENNOBLE-ATE Trial Investigators. Edoxaban for Thromboembolism Prevention in Pediatric Patients With Cardiac Disease. J Am Coll Cardiol 2022;80:2301-10.

Editorial Comment: Choueiter NF. Advancing Anticoagulation for Children With Cardiac Disease. J Am Coll Cardiol 2022;80:2311-3.

Clinical Topics: Anticoagulation Management, Cardiac Surgery, Congenital Heart Disease and Pediatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Prevention, Cardiac Surgery and Arrhythmias, Cardiac Surgery and CHD and Pediatrics, Cardiac Surgery and Heart Failure, Congenital Heart Disease, CHD and Pediatrics and Arrhythmias, CHD and Pediatrics and Interventions, CHD and Pediatrics and Prevention, CHD and Pediatrics and Quality Improvement, Acute Heart Failure, Interventions and Structural Heart Disease

Keywords: Anticoagulants, Fontan Procedure, Heart Defects, Congenital, Heart Failure, Hemorrhage, Heparin, Low-Molecular-Weight, Pediatrics, Primary Prevention, Standard of Care, Thromboembolism, Vitamin K


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