BACKGROUND: The use of vitamin-K antagonists in pediatric patients is rare and information on quality and safety of the treatment with acenocoumarol and phenprocoumon is limited.
OBJECTIVES: To assess the quality, safety and effectiveness during the first year of acenocoumarol and phenprocoumon treatment in pediatric patients in the Netherlands.
METHODS: The Children Anticoagulation and Pharmacogenetics Study (CAPS) was designed as a multicenter retrospective follow-up study. Patients, who used acenocoumarol or phenprocoumon at an age of ≤18 years, were selected in four pediatric hospitals and one anticoagulation clinic in the Netherlands. The quality of treatment was assessed by calculating the percentage of time in therapeutic INR range (TTR) for the first month and for every three months of use during the first year of treatment. Effectiveness and safety were assessed by the number of thromboembolic and bleeding events.
RESULTS: In total 213 patients participated, of whom 187 (155 acenocoumarol; 32 phenprocoumon) patients were included in this analysis. The mean TTR was 47.0% and 51.4% in the first month of use, for acenocoumarol and phenprocoumon, respectively. After the first 3 months the mean TTR was for both VKAs above 64%. In 14.6% (acenocoumarol) and 31.3% (phenprocoumon) of the patients a bleeding event occurred during the first year of treatment, no thrombotic events were reported.
CONCLUSIONS: The quality of anticoagulation treatment was low during the first month of use and leaves room for improvement. After the first month it increased to an acceptable level. However, bleeding events occurred frequently during the first year. This article is protected by copyright. All rights reserved.