Time in Therapeutic Range With Vitamin K Antagonists in Congenital Heart Disease: A Multicentre Study

Samir Basmaji1, Michelle Samuel1, Azadeh Shohoudi1

  • 1Montreal Heart Institute, Université de Montréal, Montréal, Québec, Canada.

Insights

Patients with congenital heart disease (CHD) on warfarin (Vitamin K antagonists) spent less than 42% of their time in the therapeutic range. This suboptimal anticoagulation control was linked to increased risks of blood clots and bleeding events.

Area of Science:

  • Cardiology
  • Pharmacology
  • Hematology

Background:

  • Vitamin K antagonists (VKAs) are crucial for managing atrial arrhythmias and Fontan palliation in congenital heart disease (CHD) patients.
  • Limited data exists on the time spent within the therapeutic range (TTR) for VKAs in this specific patient population.
  • This study addresses the knowledge gap concerning VKA efficacy and safety in CHD.

Purpose of the Study:

  • To determine the TTR in patients with CHD on VKAs for atrial arrhythmias or Fontan palliation.
  • To investigate the association between TTR and the occurrence of thromboembolic and bleeding events.
  • To identify factors influencing time outside the therapeutic range in this cohort.

Main Methods:

  • A multicentre North American cohort study involving patients with CHD receiving VKAs.
  • Time in therapeutic range (TTR) calculated using the Rosendaal linear interpolation method.
  • Generalized estimating equations employed to analyze factors associated with time outside the therapeutic range.

Main Results:

  • The study included 567 patients with a mean age of 33 years, predominantly female (56%).
  • Mean TTR was 41.9%, significantly below the recommended levels.
  • Thromboembolic events correlated with time below range (31.3% vs 19.1%), and bleeding events with time above range (32.5% vs 19.5%).

Conclusions:

  • Patients with CHD on VKAs achieve suboptimal TTR, spending less than 42% of monitoring time within the desired international normalized ratio (INR) range.
  • This limited TTR is associated with increased risks of both thromboembolic complications and bleeding events.
  • Improved anticoagulation management strategies are warranted for CHD patients on VKAs.
Abstract

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