Background Non-valvular atrial fibrillation (NVAF) is the most common cardiac arrhythmia in clinical practice, affecting nearly 1% of the general population. In Spain, the following recommendations are set for the choice of anticoagulant: novel oral anticoagulants (NOACs) are used in the case of poor INR control (<65% of the time in the target range (TTR)), vitamin K antagonist (VKA) intolerance or adverse events, impediment in INR controls or patients with history of stroke.1
Purpose To determine whether NOAC prescriptions fulfil the criteria of the Ministry of Health in Spain.
Material and methods Observational, non-interventional retrospective cohort study of adult patients diagnosed with NVAF during the study period (June 2010–June 2014) and treated with NOACs. TTR calculation was performed using the Rosendaal method. We estimated a right TTR if 65% or more of the time was in the range 2–3.
Results 952 patients were included in the study with a diagnosis of NVAF treated with NOACs, of whom 37% (n = 351) were treated with rivaroxaban, 57% (n = 541) with dabigatran and 6% (n = 60) with apixaban. 48% (n = 457) were male and 52% (n = 495) female, and mean age was 75.9 ± 10.7 years.
The results showed that only 64% (n = 609) met the criteria issued by the Ministry of Health, of which 11% (n = 102) were due to AVK intolerance or adverse event, 42% (n = 398) due to poor INR control (48.41 ± 19.5% mean of days in target range), 2% (n = 23) due to impediment in the INR control and 3% (n = 33) due to switching from another NOAC.
According to the different NACOs, 44% (n = 242) of dabigatran treatments did not follow the recommendations of the Ministry of Health, compared with 26% (n = 93) of treatments with rivaroxaban and 13% (n = 8) of treatments with apixaban.
Conclusion There was a high percentage (36%) of patients treated with NOACs that did not meet the criteria of the Ministry of Health.
There was a high percentage (42%) of patients who could benefit from these new anticoagulant drugs.
References and/or Acknowledgements
Criterios y recomendaciones generales para el uso de nuevos anticoagulantes orales (NACO). INFORME DE POSICIONAMIENTO TERAPÉUTICO UT/V4/23122013. 23 diciembre de 2013. In http://www.aemps.gob.es/
References and/or AcknowledgementsNo conflict of interest.
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