This Study Observes the Use of New Oral Anticoagulants (NOACs) in Patients With a Heart Rhythm Disorder in Spain

Study Overview
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Brief Summary
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The primary objective of the study is to describe the usage of NOACs in patients with NVAF, in the hospital setting, based on the baseline characteristics at the time of first NOAC initiation.

Official Title
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Non-Interventional, Cross-sectional Study to Describe NOACs Management ss in Patients With Non-valvular Atrial Fibrillation (NVAF) in Spain.

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: NOAC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient is willing and provides written informed consent to participate in this study The patient is at least 18 years of age The patient has a diagnosis of non-valvular atrial fibrillation (NVAF) The patient is on treatment with NOAC according to its approved local SmPC and has initiated his first NOAC starting from November 2016 Exclusion Criteria: -if the current participating patient participate in any clinical trial of a drug or device will be excluded

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with NVAF<br>patients with Non Valvular Atrial Fibrillation | Drug: NOAC<br>* New Oral Anticoagulant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usage of NOAC Based on Baseline Characteristics: Age at the Time of the First NOAC Initiation | Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics; age, at the time of the start of the first NOAC initiation. | Start of the first NOAC treatment | 
| Usage of NOAC Based on Baseline Characteristics: CHA2DS2-VASc Scores at the Time of the First NOAC Initiation | Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics: Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc Score) at the time of the start of the first NOAC initiation. The CHA2DS2-VASc score is a clinical prediction rule to estimate the risk of stroke in patients with Atrial Fibrillation (AF); it is frequently used to determine the need for an anticoagulation therapy, relating the high scores to a great risk of stroke and a low score corresponds to a lower risk of stroke. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. | Start of the first NOAC treatment | 
| Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation | Number of patients on risk (Low, Moderate and High) based on CHA2DS2-VASc Scores at the time of the start of the first NOAC initiation. The total CHA2DS2-VASc Scores score was stratified by category according to the following classification: Low risk (score 0 in male; score 1 in female) Moderate risk (score 1 in male; score 2 in female) High risk (score ≥2 in male; score ≥3 in female) | Start of the first NOAC treatment | 
| Usage of NOAC Based on Baseline Characteristics: HAS-BLED Score at the Time of the First NOAC Initiation | Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics: Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs and Alcohol (HAS-BLED Score) at the time of the start of the first NOAC initiation. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. The high scores to a great risk of bleeding and a low score corresponds to a lower risk of bleeding. | Start of the first NOAC treatment | 
| Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation | Number of patients on risk (Low, Moderate and High) based on HAS-BLED Score at the time of the start of the first NOAC initiation. The total HAS-BLED Score was stratified by category according to the following classification: Low risk (score 0) Moderate risk (score 1-2) High risk (score ≥3) | Start of the first NOAC treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appropriateness of NOACs Prescription | Appropriateness of NOACs prescription based on national recommendations. For this, it was reviewed if the presence of at least one of the following clinical reason or reason related to International Normalized Ratio (INR) control were met. Reason 1: Patients with known hypersensitivity or with specific contraindications to the use of acenocoumarol or warfarin; Reason 2: Patients with a history of intracranial hemorrhage (ICH) (except during the acute phase); Reason 3: Patients with ischemic stroke who present high-risk clinical and neuroimaging criteria for ICH; Reason 4: Patients on VKA treatment who suffer from severe arterial thromboembolic events despite good INR control; Reason 5: Patients who have started treatment with VKA in which it is not possible to maintain INR control within range (2-3) despite good therapeutic compliance; Reason 6: impossibility of access to conventional INR control; Reason 7: Other reason; Reason 8; Unknown. | single visit (Day 1) | 
| Mean Number of Visits to the Physician Per Year | Mean number of visits to the physician per year considered for the NOAC Management. | 1 year (data collected during single visit on day 1) | 
| Duration of First NOAC, All NOAC and Subsequent NOAC Treatment | Duration of NOAC treatment (First NOAC, All NOAC and Subsequent NOAC). | Through the observational period with an average of 9.4 (first NOAC), 9.6 (All NOAC) and 5.1 (Subsequent NOAC) months, data collected during a single visit. | 
| Number of Patients Who Required Discontinuing the NOAC Treatment, to Adjust the NOAC Dose or to Change to a New NOAC | Number of patients who required discontinuing the NOAC treatment, to adjust the NOAC dose or to change to a new NOAC | single visit (Day 1) | 
| Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose | Number of patients who changed from one NOAC to a new NOAC type and dose. The treatment and its dose displayed below refer to the subsequent NOAC. | single visit (Day 1) | 
| Reason for Treatment Changes | Reason for treatment changes such as discontinuing the NOAC treatment, to adjust the NOAC dose or to change to a new NOAC. | Start of the first NOAC treatment | 
| Number of Patients With Previous Treatment With Vitamin K Antagonists | Number of patient with Previous Treatment with Vitamin K Antagonists. | single visit (Day 1) | 
| Duration of Previous VKA Treatment | Duration of previous VKA treatment is the time from start of the VKA treatment until stopped to start with the first NOAC | Through the observational period with an average of 43.8 months, data collected during a single visit. | 
| Patient's Knowledge About His Condition | At the time of the inclusion, the physician performed a following small questionnaire to the patients, to answer yes/no, in order to assess the patient's knowledge about his illness and the anticoagulant treatment prescribed. Question 1. Do you know why you are being treated with an anticoagulant? Question 2. Do you know which the effect of the anticoagulant treatment is? Question 3. Do you know what could happen if you don't take the anticoagulant treatment? Question 4. Do you mind taking the anticoagulant treatment? | single visit (Day 1) |