DOI: 10.5281/zenodo.5040652
title: ASSESSMENT OF ADHERENCE TO NEW ORAL ANTICOAGULANTS IN ATRIAL FIBRILLATION PATIENTS WITHIN THE OUTPATIENT REGISTRY PROFILE. PROSPECTIVE OBSERVATIONAL STUDY (ANTEY study)

description: <strong>Rationale</strong> Prevention of stroke and thromboembolic complications in non-valvular atrial fibrillation is one of the most common indications for the use of all NOACs and warfarin in cardiology. The issue of regular intake of all OACs, i.e. the issue of adherence to anticoagulation therapy, is paramount for better treatment. The problem of assessment of different aspects of adherence to OACs in patients with atrial fibrillation within an outpatient registry is of current interest. <strong>Primary</strong> <strong>Study</strong> <strong>Objectives</strong> The aim of the present study is to assess adherence to therapy and factors associated with adherence in patients with CV disease complicated by non-valvular atrial fibrillation requiring OAC treatment within the outpatient registry PROFILE (prospective, observational study). Data collection in patients with non-valvular atrial fibrillation requiring OAC treatment included in the registry Evaluation of actual patient adherence to OACs <strong>Secondary Study Objective(s)</strong> Evaluation of potential patient adherence to OACs Determination of most significant factors associated with adherence to OACs in patients with non-valvular AF Validation of new original questionnaire Evaluation of doctor’s adherence to OAC prescription according to Guidelines (ESC). Management of atrial fibrillation,2016) <strong>Material and methods</strong> .The study included 201 patients with nonvalvular AF from the outpatient "PROFILE" registry, 118 (58,7%) males. The mean age was 71,1 ±8,7 years. The study protocol consisted of the inclusion visit (V0), 6-month follow-up visit (V1), and phone contact 1 year after V0 (follow-up, FU). In V0, all patients were prescribed one of the NOACs. At V1 doctors could recommend warfarin or another NOAC to patients, who have refused to take prescribed NOAC. Medical adherence was determined using the original questionnaire <strong>Inclusion Criteria (detailed)</strong> Men and women above 18 years of age who were included in the "PROFILE" registry by the start of the observational study Presence of written informed consent to participate in the study, fill in the study questionnaires, and have personal data analyzed Presence of any form of non-valvular atrial fibrillation with CHA<sub>2</sub>DS<sub>2</sub>-VASc score of ≥1 or patients with CHA<sub>2</sub>DS<sub>2</sub>-VASc score = 0, who are already taking OAK <strong>Exclusion Criteria</strong> Patients with high bleeding risk, including patients with: Congenital or acquired bleeding disorders Uncontrolled resistant hypertension Exacerbation of gastric and duodenal ulcer Vascular retinopathy Recent history of intracranial or intracerebral hemorrhage Pathology of the brain and spinal cord vessels Recent history of the brain, spinal cord, or eye surgery History of bronchiectasis or pulmonary hemorrhage A CHA<sub>2</sub>DS<sub>2</sub>-VASc score of 0 (OACs are not indicated) Pregnancy, lactation Planned surgery Known hypersensitivity to ingredients of medications used in the study <strong>Visit schedule</strong> Visit schedule Two visits at 6-month intervals are scheduled for each patient as part of routine clinical practice: Visit 0– visit at study entry: receiving written informed consent to participate in research from patients inclusion in the program assessment of inclusion and exclusion criteria verification of non-valvular atrial fibrillation diagnosis (according to medical documentation, confirming the history of atrial fibrillation: ECG, Holter monitoring, etc..) collecting information on received medication therapy, including OACs physical examination of patients (measurements of blood pressure, heart rate, height, weight, waist circumference) questioning of patients to determine potential and actual adherence to OACs computation of points on the scale CHA<sub>2</sub>DS<sub>2</sub>-VASc and HAS-BLED to determine the indications for the appointment of the OACs and the identification of an increased risk of bleeding to determine the INR in patients who agreed to replace the use of warfarin with one of the NOACs prescription of OACs according to routine clinical practice and official labels for these medications instructing patients (according to the specifically designed scheme) to regularly take prescribed medications, be aware of precautionary measures when taking OACs, telling them about the pros and cons of treatment with OACs Visit 1 – visit at 6 months after the Visit 0: collecting information on patients’ compliance with doctor’s recommendations collecting information on patients’ actual medication therapy collecting information on the safety of treatment with OACs (in case the patient has been taking them), recording all adverse events that occurred during the study period measurements of blood pressure, heart rate as a part of routine clinical practice questioning of patients to determine potential and actual adherence to OACs FU - follow-up calls to patients (one year) Phone contact to determine patient’s life status, possible (fatal and non-fatal complications of non-valvular atrial fibrillation) and fill (after receiving patient’s consent) the original questionnaire. <strong>Primary Outcome</strong> The proportion of complete, partial adherent and non-adherent patients according to the original questionnaire <strong>Secondary Outcomes </strong> The proportion of potentially adherent patients (according to the original questionnaire) Identification of baseline characteristics associated with adherence The proportion of doctors prescribed OAC according to guidelines. <strong>Safety Outcomes </strong> Adverse events and outcomes were recorded from the start of treatment with the OAC until the end of the observational study period. The doctor evaluated the severity of adverse events and outcomes if necessary took measures for their medical treatment according to current clinical practice.
description: This research was funded by AG BAYER with the reference number IIR-RU-2016-3743. The sponsor had no role in data collection, and analysis, the decision to publish, or preparation manuscripts.