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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.
Background:
Vitamin K antagonists (VKAs) are frequently prescribed to patients with congenital heart disease (CHD) for atrial arrhythmias or Fontan palliation, but there is a paucity of data regarding time spent in the therapeutic range (TTR). We sought to determine the TTR in patients with CHD and atrial arrhythmias or Fontan palliation prescribed VKAs and explore associations with thromboembolic and bleeding events.
Methods:
A multicentre North American cohort study was conducted on patients with CHD who received VKAs for sustained atrial arrhythmia or Fontan palliation. TTR was calculated using the Rosendaal linear interpolation method. Generalized estimating equations were used to explore factors associated with time outside the therapeutic range.
Results:
A total of 567 patients, aged 33 ± 17 years, 56% female, received VKAs for 11.5 ± 8.4 years for atrial arrhythmias (63.0%) or Fontan palliation (58.0%). CHD was simple, moderate, and complex in 10.8%, 20.3%, and 69.0%, respectively. Site investigators perceived good control over international normalized ratio (INR) levels in most patients (75.3%), with no or minor compliance or adherence issues (85.6%). The mean TTR was 41.9% (95% confidence interval [CI], 39.0%-44.8%). Forty-seven (8.3%) and 34 (6.0%) patients had thromboembolic and bleeding events, respectively. Thromboembolic events were associated with a higher proportion of time below the therapeutic range (31.3% vs 19.1%, P = 0.003) and bleeding complications with a higher proportion of time above the therapeutic range (32.5% vs 19.5%, P = 0.006).
Conclusions:
Patients with CHD who receive VKAs spend < 42% of their time with INR levels in the therapeutic range, with repercussions regarding thromboembolic and bleeding complications.
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