ASSESSMENT OF ADHERENCE TO NEW ORAL ANTICOAGULANTS IN ATRIAL FIBRILLATION PATIENTS WITHIN THE OUTPATIENT REGISTRY PROFILE. PROSPECTIVE OBSERVATIONAL STUDY (ANTEY study)

Rationale

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.

Primary Study Objectives

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

Secondary Study Objective(s)

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)

Material and methods

.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

Inclusion Criteria (detailed)

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 CHA2DS2-VASc score of ≥1 or patients with CHA2DS2-VASc score = 0, who are already taking OAK

Exclusion Criteria

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 CHA2DS2-VASc score of 0 (OACs are not indicated)

Pregnancy, lactation

Planned surgery

Known hypersensitivity to ingredients of medications used in the study

Visit schedule

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 CHA2DS2-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.

Primary Outcome

The proportion of complete, partial adherent and non-adherent patients according to the original questionnaire

Secondary Outcomes

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.

Safety Outcomes

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.