INR Control and Atrial Fibrillation in Primary Care in Spain (PAULA)
Status:
Completed
Trial end date:
2014-10-01
Target enrollment:
Participant gender:
Summary
The primary objective of this study was to determine rates of INR control of patients with
nonvalvular AF daily attended in primary care in Spain.
PAULA is an observational retrospective/cross-sectional and multicenter study. Patients aged
≥18 years old, with nonvalvular AF, treated with VKAs for at least one year in primary care
were included in the study. To be included, at least 80% of INR values during the past 12
months should be available. Before inclusion, patients provided written consent.
Clinical data (biodemographic data, comorbidities, treatments, and thromboembolic/bleeding
risk) were recorded from the clinical history of patients at the moment of inclusion. INR
values were taken from the previous 12 months of inclusion.
Poor INR control was considered when percent time in therapeutic INR range (TTR) was <65%
(calculated by Rosendaal method) or <60% by direct method (proportion of INR values).
A total of 1,524 patients have been included in the study.