Background Non-valvular atrial fibrillation (NVAF) is the most common cardiac arrhythmia in clinical practice, affecting nearly 1% of the general population.1 In Spain, the stipulated recommendations to select anticoagulant are: use of novel oral anticoagulants (NOACs) in case of poor international normalised ratio (INR) control (<65% of the time in the target range (TTR)), intolerance to vitamin K antagonists (VKA) or adverse events, impediment in INR controls or patients with a medical history of stroke disease.
Purpose To determine whether NOAC prescriptions fulfil the established criteria by the Spanish Ministry of Health.
Material and methods An observational, non-interventional retrospective cohort study was conducted in adult patients diagnosed with NVAF during the study period (June 2010 to June 2014) and treated with NOACs. TTR calculation was performed using the Rosendaal method. We estimated that correct TTR was in the range 2–3 at least 65% of the time.
Results 952 patients were included in the study. 37% of these patients (n=351) was treated with rivaroxaban, 57% (n=541) with dabigatran and 6% (n=60) with apixaban. 48% (n=457) were men and 52% (n=495) were women. Mean age of the patients was 75.9±10.7 years. The results showed that only 64% of patients (n=609) met the criteria issued by the Ministry of Health, of whom 11% (n=102) were due to VKA intolerance or adverse events, 42% (n=398) due to poor INR control (48.41±19.5% mean days in target range), 2% (n=23) due to impediment in the INR control and 3% (n=33) due to switch from another NOAC. According to the different types of NOACs, 44% (n=242) of dabigatran treatments did not follow the Ministry of Health recommendations, in contrast with 26% (n=93) of rivaroxaban treatments and 13% (n=8) of apixaban treatments.
Conclusion A high percentage (36%) of patients treated with NOACs do not meet the Ministry of Health criteria. A high percentage (42%) of patients might benefit from these new anticoagulant drugs.
References and/or acknowledgements 1. Criterios y recomendaciones generales para el uso de nuevos anticoagulantes orales (NACO). en pacientes con fibrilación auricular no valvular. In http://www.aemps.gob.es
No conflict of interest
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.