This Study Observes the Usage of Non-vitamin K Antagonist Oral Anticoagulants (NOACs) in Elderly Patients With a Heart Rhythm Disorder in Spain
Study Details
Study Description
Brief Summary
This is an observational, multicenter and cross-sectional study in Non-valvular atrial fibrillation (NVAF) elderly patients currently on Non-vitamin K antagonist oral anticoagulant (NOAC) treatment for their stroke prevention.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
patients with NVAF
|
Drug: Non-vitamin K antagonist oral anticoagulant
Non-vitamin K antagonist oral anticoagulant
|
Outcome Measures
Primary Outcome Measures
- Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Current NOAC Dose According to Sex [At the single study visit (Day 1).]
Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to sex is reported.
- Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Sex [At the single study visit (Day 1).]
Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to sex is reported.
- Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Age (Categorical) [At the single study visit (Day 1).]
Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to patients' age is reported.
- Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Patient's Age (Categorical) [At the single study visit (Day 1).]
Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to patient's age (categorical) is reported.
- Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to a Prior Diagnosis of Heart Failure [At the single study visit (Day 1).]
Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to a prior diagnosis of heart failure is reported.
- Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to a Prior Diagnosis of Heart Failure [At the single study visit (Day 1).]
Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to a prior diagnosis of heart failure is reported.
- Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Coronary Artery Disease [At the single study visit (Day 1).]
Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the study visit according to patients' coronary artery disease is reported.
- Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Coronary Artery Disease [At the single study visit (Day 1).]
Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to patients' coronary artery disease is reported.
- Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Diabetes [At the single study visit (Day 1).]
Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to patients' diabetes is reported.
- Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Diabetes [At the single study visit (Day 1).]
Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to patients' diabetes is reported.
- Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Chronic Kidney Disease [At the single study visit (Day 1).]
Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to patients' chronic kidney disease is reported.
- Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Chronic Kidney Disease [At the single study visit (Day 1).]
Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to patients' chronic kidney disease is reported.
Secondary Outcome Measures
- Serum Creatinine Concentration From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]
Serum creatinine concentration from the last available blood sample analysis was retrieved from patients' medical records. Serum creatinine concentration from the last available blood sample analysis according to current NOAC type is reported.
- Creatinine Clearance From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]
Results from the last available blood sample analysis from patients' medical records were used to retrieve the creatinine clearance (CrCl). These results were directly collected in the Electronic Case Report Form (eCRF). In cases where CrCl was not available in patients's medical record but serum creatinine was available, CrCl was estimated using Cockcroft-Gault formula: CrCl = (140 - Age(years)) x Weight (kilogram) x [0.85 if female] / 72 x [Serum Creatinine (milligram/deciliterL)] Reported are Crcl values which are calculated according to: Cockcroft-Gault formula and CrCl values directly collected in the eCRF Cockcroft-Gault formula only Directly collected in the eCRF
- Number of Participants in Each Category of Creatinine Clearance Range From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]
Results from the last available blood sample analysis from patients' medical records were used to retrieve the creatinine clearance (CrCl). These results were directly collected in the Electronic Case Report Form (eCRF). In cases where CrCl was not available in patients' medical record but serum creatinine was available, CrCl was estimated using Cockcroft-Gault formula: CrCl = (140 - Age(years)) x Weight (kilogram) x [0.85 if female] / 72 x [Serum Creatinine (milligram/deciliterL)] The number of participants for each of the following creatinine clearance (CrCl) ranges is reported: CrCl ≥90: Kidney damage with normal or increased glomerular filtration rate (GFR) CrCl 60-89: Kidney damage with mild decreased GFR CrCl 30-59: Moderate decrease in GFR CrCl 15-29: Severe decrease in GFR CrCl <15: Kidney failure
- Aspartate Aminotransferase (AST) Concentration From the Last Available Blood Sample According to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]
Results from the last available blood sample analysis from patients' medical records were used to retrieve AST concentration. AST concentration from the last available blood sample according to non-vitamin K antagonist oral anticoagulant (NOAC) type is reported.
- Alanine Aminotransferase (ALT) From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]
Results from the last available blood sample analysis from patients's medical records were used to retrieve ALT concentration. ALT concentration from the last available blood sample according to NOAC type is reported.
- Bilirubin Concentration From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]
Results from the last available blood sample analysis from patients's medical records were used to retrieve bilirubin concentration. Bilirubin concentration from the last available blood sample according to NOAC type is reported.Results from the last available blood sample analysis from patients' medical records were used to retrieve bilirubin concentration. Bilirubin concentration from the last available blood sample according to NOAC type is reported.
- Haemoglobin Concentration From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]
Results from the last available blood sample analysis from patients' medical records were used to retrieve haemoglobin concentration. Haemoglobin concentration from the last available blood sample according to NOAC type is reported.
- Platelet Levels From the Last Available Blood Sample According to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]
Results from the last available blood sample analysis from patients's medical records were used to retrieve platelet levels. Platelet levels from the last available blood sample according to NOAC type is reported.
- Number of Patients in Each Category of Serum Creatinine, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin, Hemoglobin and Platelet Levels According to Current Non-vitamin K Antagonist Oral (NOAC) Type [At the single study visit (Day 1).]
Results from the last available blood sample analysis from patients' medical records were used to retrieve serum creatinine, ALT, AST, bilirubin, hemoglobin concentration and platelet levels. For each reported laboratory parameter the values were categorized in two categories: Serum creatinine: Normal value : 0.6-1.2 mg/dl in males and 0.5-1.1 mg/dl in females High/low value ALT: Normal values: 7-55 units per liter (UI/L) High/low values AST: Normal values: 8-48 UI/L High/low values Bilirubin: Normal values: 0.2-1.2 milligram per deciliter (mg/dl) High/low values Haemoglobin: Normal values: 12-18 gram/deciliter (g/dL) High/low values Platelets: Normal values: 150-450 x10^3/µL High/low values
- Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Years Since NVAF Diagnosis According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (day 1).]
The number of years since NVAF diagnosis was obtained from number of years between date of NVAF diagnosis and date of study visit. The date of NVAF diagnosis was retrieved from patient's medical records. The number of years since NVAF diagnosis and date of study visit is reported for: All patients; Patients treated previously with vitamin K antagonists (VKA); Patients treated with NOAC as first anticoagulant .
- Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Patients in Each Category of NVAF Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (day 1).]
NVAF was categorized in four categories: Persistent; Long standing persistent; Permanent; Paroxysmal.
- Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Patients in Each Category of EHRA Scale for Atrial Fibrillation (AF) Related Symptoms According to Current NOAC Type [At the single study visit (day 1).]
The European Heart Rhythm Association (EHRA) score of atrial fibrillation is a classification system for the extent of atrial fibrillation. It places patients in one of five categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina. The EHRA categories are the following: 1-no symptoms 2a-mild symptoms; normal daily activity not affected. 2b-moderate symptoms; normal daily activity not affected. 3-severe symptoms; normal daily activity affected. 4-disabling; normal daily activity discontinued.
- Number of Patients in Each Category of Cardioversion, Ablation, Coronary Interventions and Pacemaker Carrier According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]
Number of patients with (category Yes) and without (category No) cardioversion, ablation, coronary interventions and pacemaker carrier according to current NOAC type is reported.
- Number of Patients in Each Category of Coronary Interventions According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]
Number of patients in each category of coronary interventions according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported. Coronary interventions were categorized in: Percutaneous coronary intervention and Coronary artery bypass grafting.
- Clinical Risk Factors: Number of Patients in Each Category of Heart Failure, Coronary Artery Disease, Sleep Apnoea-hypopnoea Syndrome, Hypertension and Hyperlipidaemia According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]
Number of patients in each category of heart failure, coronary artery disease, sleep apnoea-hypopnoea syndrome, hypertension and hyperlipidaemia according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported. Heart failure, coronary artery disease, sleep apnoea-hypopnoea syndrome, hypertension and hyperlipidaemia were categorized in the following two categories: No; Yes.
- Clinical Risk Factors: Number of Heart Failure Patients in Each Category of New York Heart Association (NYHA) Classification According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]
The NYHA provides a simple way of classifying the extent of heart failure and it has 4 categories: A - No objective evidence of cardiovascular disease B - Objective evidence of minimal cardiovascular disease C - Objective evidence of moderately severe cardiovascular disease D - Objective evidence of severe cardiovascular disease Number of heart failure patients in each category of New York Heart Association (NYHA) classification according to current NOAC type is reported.
- Clinical Risk Factors: Left Ventricular Ejection Fraction According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]
Left ventricular ejection fraction (LVEF) according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported. LVEF was obtained from the patients' medical records.
- Age-adjusted Charlson Comorbidity Index Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]
The Charlson Comorbidity Index is a method of categorizing comorbidities of patients based on the International Classification of Diseases (ICD) diagnosis. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use. Up to 12 comorbidities with various weightings can result in a maximum score of 24. The minimum score is zero.
- Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]
Number of patients with (Yes) and without (No) the comorbidities which were included in the Charlson Comorbidity Index according to current NOAC type is reported. The comorbidities which were included in the Charlson Comorbidity Index were the following: Myocardial infarction Congestive heart failure Peripheral vascular disease Cerebrovascular disease Dementia Chronic Obstructive Pulmonary Disease (COPD) Connective tissue disease Peptic ulcer disease Liver disease (No/Mild/Moderate to severe) Diabetes mellitus (No/Uncomplicated/End-organ damage) Hemiplegia Moderate to severe renal disease Solid Tumor (No/Localized/Metastatic) Leukaemia Lymphoma Acquired Immune Deficiency Syndrome (AIDS).
- Number of Patients With and Without Any History of Thromboembolic Events, Number of Patients in Each Category of Different Types of Thromboembolic Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]
Reported is the number of patients in each category of: Any history of thromboembolic events Transient Ischemic Attack (TIA) Ischemic stroke Haemorrhagic stroke Embolism systemic Deep vein thrombosis Pulmonary embolism. Any history of thromboembolic events, Transient Ischemic Attack (TIA), ischemic stroke, haemorrhagic stroke, embolism systemic, deep vein thrombosis and pulmonary embolism were categorized in the following two categories: No Yes.
- Number of Patients in Each Category of Stable Angina, Unstable Angina, Myocardial Infarction With ST Segment Elevation and Myocardial Infarction Without ST Segment Elevation According to Current NOAC Type [At the single study visit (Day 1).]
Number of patients in each category of stable angina, unstable angina, myocardial infarction with ST segment elevation and myocardial infarction without ST segment elevation according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported. Stable angina, unstable angina, myocardial infarction with ST segment elevation myocardial infarction without ST segment elevation were categorized in the following 2 categories: Yes; No.
- Total Number of Thromboembolic Events, Number of Each Type of Thromboembolic Events, Number of Stable and Unstable Anginas, and Number of ST and Non-ST Myocardial Infarction According to Current NOAC Type [At the single study visit (Day 1).]
Total number of thromboembolic events, number of each type of thromboembolic events, number of stable and unstable anginas, and number of ST and non-ST myocardial infarction according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported.
- Number of Patients With and Without Any History of Bleeding Events and Number of Patients in Each Category of Bleeding Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]
Number of patients with (category Yes) and without (category No) any history of bleeding events and number of patients in each category of the following bleeding types is reported: Intracranial Digestive Genitourinary Gingival Nasal Pulmonary Articular-muscular Conjunctival. Intracranial, digestive, genitourinary, gingival, nasal, pulmonary, articular-muscular, conjunctival were categorized in two categories: No Yes.
- Total Number of Bleeding Events and Number of Each Type of Bleeding Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]
Total number of bleeding events and number of bleeding events for the following bleeding types is reported: Intracranial Digestive Genitourinary Gingival Nasal Pulmonary Articular-muscular Conjunctival.
- CHA2DS2-VASc Total Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]
The Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (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.
- Number of Patients on Each Category of CHA2DS2-VASc Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]
The Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc) total score was categorized in three categories, according to the risk of stroke: 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)
- HAS-BLED Total Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]
Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile International Normalized Ratio (INR), Elderly (>65 years), Drugs and Alcohol (HAS-BLED) score may range from 0 to 9 with 0 being the best outcome. The high scores indicate a greater risk of bleeding and a low score corresponds to a lower risk of bleeding.
- Number of Patients in Each Category of HAS-BLED Score According to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]
The Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs and Alcohol (HAS-BLED) total score was categorized in three categories according to the bleeding risk: Low risk (score 0) Intermediate risk (score 1-2) High risk (score ≥3)
- Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type [At the single study visit (Day 1).]
Number of patients in each category (No;Yes) of any concomitant treatments to NOAC and number of patients in each category (No; Yes) for each concomitant treatment to NOAC at study visit according to current NOAC type is reported. The concomitant treatment to non-vitamin K antagonist oral anticoagulant (NOAC) were the following: Angiotensin-Receptor Blockers (ARB) or Angiotensin Converting Enzyme inhibitors (ACE) inhibitor Beta-blocker Calcium channel blockers Diuretics Amiodarone Statin Proton pump inhibitor H2-receptor antagonist Digoxin NSAIDs (Nonsteroidal Anti-Inflammatory Drugs) Dronedarone Ketoconazole Cyclosporine Itraconazole Other antiarrhythmics
- Number of Patients in Each Category of Previous Vitamin K Antagonists (VKA) Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation [At the single study visit (Day 1).]
Number of patients in each category of previous Vitamin K Antagonists (VKA) treatment according to duration since the first non-vitamin K antagonist oral anticoagulant (NOAC) initiation is reported. Previous VKA treatment was categorized in 2 categories: No; Yes.
- Number of Patients Treated Previously With the VKA Acenocoumarol and Number of Patients Treated Previously With the VKA Warfarin According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]
Number of patients treated previously (before they were treated with non-vitamin K antagonist oral anticoagulant (NOAC)) with the Vitamin K Antagonists (VKA) acenocoumarol and number of patients treated previously with the VKA warfarin according to duration since the first NOAC initiation is reported.
- Duration of Previous Vitamin K Antagonists (VKA) Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation [At the single study visit (Day 1).]
Duration of treatment (in years) is reported for: All patients treated previously with Vitamin K Antagonists (VKA) (row:All patients treated previously with VKA) Patients treated only with the VKA warfarin (row: Warfarin patients) Patients treated only with the VKA acenocoumarol (row: Acenocoumarol patients)
- Duration Since Non-valvular Atrial Fibrillation (NVAF) Diagnosis Until First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]
Duration (in years) since non-valvular atrial fibrillation (NVAF) diagnosis until first NOAC initiation according to duration since the first NOAC initiation is reported for: All patients Patients treated previously with VKA Patients treated only with NOAC as anticoagulant (AC)
- First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and First NOAC Dose According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]
Number of patients who received dabigatran, rivaroxaban, apixaban, edoxaban as first NOAC and number of patients who received dabigatran 110 mg BID (twice daily), dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD as first NOAC according to duration since the first NOAC initiation is reported.
- Number of Patients Who Changed (Increased and Decreased) and Did Not Change the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Dose According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]
Number of patients who changed (increased and decreased) and did not change the first non-vitamin K antagonist oral anticoagulant (NOAC) dose according to duration since the first NOAC initiation is reported.
- First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Duration (in Years) According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]
Treatment duration (in years) is reported for: Patients who stopped first NOAC treatment; Patients who did not stop the first NOAC treatment.
- Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Discontinuation According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]
Reason for first NOAC treatment discontinuation was categorized in four categories: Lack of effectiveness Investigator's decision Patient's decision Adverse event
- Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Change Dose According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]
Reason for first NOAC treatment change was categorized in four categories: Lack of effectiveness Investigator's decision Patient's decision Adverse event
- Number of Switches to a New Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Per Patient According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]
Number of switches to a new non-vitamin K antagonist oral anticoagulant (NOAC) per patient according to duration since the first NOAC initiation is reported.
- Number of Patients in Each Category of Number of Switches to a New Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Per Patient According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]
Number of patients based on the number of switches to a new NOAC per patient according to duration since the first NOAC initiation is reported. Number of switches to a new NOAC was categorized in 3 categories: 0 switches 1 switch 2 switches.
- Total Number of Switches According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation [At the single study visit (Day 1).]
Total number of switches according to duration since the first NOAC initiation is reported.
- Number of Switches in Each Category of Reason for Switch According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation [At the single study visit (Day 1).]
Reason for switch was categorized in four categories: Lack of effectiveness Investigator's decision Patient's decision Adverse event
- Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Second NOAC Dose According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]
Number of patients who received dabigatran, rivaroxaban, apixaban, edoxaban as second NOAC and number of patients who received dabigatran 110 mg BID (twice daily), dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD as second NOAC according to duration since the first NOAC initiation is reported.
- Number of Patients Who Changed (Increased or Decreased) and Did Not Change the Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Dose According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]
Number of patients who changed (increased or decreased) and did not change the second non-vitamin K antagonist oral anticoagulant (NOAC) dose according to duration since the first NOAC initiation is reported.
- Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Duration (in Years) According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]
Second NOAC treatment duration (in years) according to duration since the first NOAC initiation is reported.
- Number of Patients in Each Category of Reason for Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Discontinuation According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]
Reason for second non-vitamin K antagonist oral anticoagulant (NOAC) treatment discontinuation was categorized in four categories: Lack of effectiveness Investigator's decision Patient's decision Adverse event
- Number of Patients in Each Category of Reason for Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Change Dose According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]
Reason for second NOAC treatment change was categorized in four categories: Lack of effectiveness Investigator's decision Patient's decision Adverse event
- Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Third NOAC Dose According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]
Number of patients who received dabigatran, rivaroxaban, apixaban, edoxaban as third NOAC and number of patients who received dabigatran 110 mg BID (twice daily), dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD as third NOAC according to duration since the first NOAC initiation is reported.
- Number of Patients Who Changed (Increased and Decreased) and Did Not Change the Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Dose According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]
Number of patients who changed (increased and decreased) and did not change the third non-vitamin K antagonist oral anticoagulant (NOAC) dose according to duration since the first NOAC initiation is reported.
- Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Duration (in Years) According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]
Duration of third NOAC treatment for patients who stopped NOAC treatment.
- Number of Patients in Each Category of Reason for Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Discontinuation According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]
Reason for Third NOAC treatment discontinuation was categorized in four categories: Lack of effectiveness Investigator's decision Patient's decision Adverse event
- Number of Patients in Each Category of Reason for Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Change Dose According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]
Reason for Third NOAC treatment change was categorized in four categories: Lack of effectiveness Investigator's decision Patient's decision Adverse event
- Duration (in Years) in Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]
Duration (in years) in NOAC treatment is reported for: All patients (patients who received or did not receive VKA) Patients treated previously with Vitamin K Antagonists (VKA) Patients treated with NOAC as first anticoagulant
- Number of Patients in Each Category of Total Time in Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]
Number of patients in each category of total time in non-vitamin K antagonist oral anticoagulant (NOAC) treatment according to duration since the first NOAC initiation is reported. Total time in NOAC treatment was categorized in 4 categories: <1 year; 1-2 years; 2-3 years; >3 years.
- Number of Patients for Each Type of Antiplatelet Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation [At the single study visit (Day 1).]
Number of patients for each type of following antiplatelet treatment that the patients ever received is reported: None (reports the patients who did not receive any antiplatelet treatment) Acetyl salicylic acid Clopidogrel Prasugrel Ticlopidine Ticagrelor Cilostazol Triflusal Dipyridamole Others (other antiplatelet treatment than above mentioned).
- Number of Patients for Each Type of Antiplatelet Treatment at the Time of Study Visit According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]
Number of patients for each of the following antiplatelet treatment types at the time of study visit according to duration since the first NOAC initiation is reported: None (reports the patients who did not receive any antiplatelet treatment) Acetyl salicylic acid Clopidogrel Prasugrel Ticlopidine Ticagrelor Cilostazol Triflusal Dipyridamole Others (other antiplatelet treatment than above mentioned).
- Time in Treatment With Antiplatelet Agents (in Years) According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation [At the single study visit (Day 1).]
Time in treatment with antiplatelet agents (in years) according to duration since the first NOAC initiation is reported.
- Number of Patients in Each Score of Clinical Frailty Scale Grading at the Time of the Study Visit According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]
Clinical Frailty Scale (CFS) is used commonly to assess frailty. It is a 9-point scale from 1 to 9 (1=very fit; 2=well; 3=Managing well; 4=Vulnerable; 5=Mildly frail; 6=Moderately frail; 7=Severely frail; 8=very severely frail; 9=terminally ill) that summarizes the overall level of fitness or frailty of an older adult after they had been evaluated by a health care professional. Applying the CFS to patients is quick and requires data collection by watching the patient (mobilize), inquiring about their habitual physical activity and ability. A person with a score >4 was considered frail.
- Number of Patients in Each Category Clinical Frailty Scale at the Time of the Study Visit According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]
Clinical Frailty Scale (CFS) is used commonly to assess frailty. It is a 9-point scale from 1 to 9 (1=very fit; 2=well; 3=Managing well; 4=Vulnerable; 5=Mildly frail; 6=Moderately frail; 7=Severely frail; 8=very severely frail; 9=terminally ill) that summarizes the overall level of fitness or frailty of an older adult after they had been evaluated by a health care professional. Applying the CFS to patients is quick and requires data collection by watching the patient (mobilize), inquiring about their habitual physical activity and ability. CFS was categorized in two categories, according to this ranges: Frailty patients - CFS scoring >4 Non-frailty patients - CFS scoring ≤4
- Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Usage at the Time of First NOAC Initiation According to Current NOAC Type [At the single study visit (Day 1).]
Reason for First NOAC usage was categorized in the following two categories: Primary prevention; Secondary prevention.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients are willing and provide written informed consent prior to participate in this study
-
Patients ≥ 75 years-old at the time of the study visit.
-
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF).
-
Patients who are being treated with NOAC treatment according to the indication approved in the Summary of Product Characteristics (SmPC).
-
Patients who have started the NOAC treatment at least 3 months prior to the study visit.
Exclusion Criteria:
Patients will be excluded from participating in this study if the following criterion is met:
-
Current participation in any clinical trial of a drug or device.
-
Patients who have any contraindication for NOAC treatment, according to the SmPC.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | H. Fundación Alcorcón | Alcorcón, Madrid | Spain | 28922 | |
2 | Consulta Privada | Almería | Spain | 4630 | |
3 | H. Dr. José Molina Orosa | Arrecife, Las Palmas | Spain | 35500 | |
4 | Centro Médico San Juan de Dios | Barakaldo, Bizkaia | Spain | 48901 | |
5 | H. Sagrat Cor | Barcelona | Spain | 8029 | |
6 | H. Vall d'Hebron | Barcelona | Spain | 8035 | |
7 | H. Sant Pau | Barcelona | Spain | 8041 | |
8 | H. Vithas Internacional Xanit | Benalmádena, Málaga | Spain | 29631 | |
9 | Ambulatorio Txurdinaga | Bilbao | Spain | 48004 | |
10 | H. San Juan de Dios de Bormujos | Bormujos, Sevilla | Spain | 41930 | |
11 | H. Provincial de Castellón | Castellón | Spain | 12002 | |
12 | H. San Pedro Alcántara | Cáceres | Spain | 10003 | |
13 | Consulta privada Dr. Ruiz | Córdoba | Spain | 14006 | |
14 | H. Arquitecto Marcide | Ferrol, A Coruña | Spain | 15405 | |
15 | H. de Jaen | Jaen | Spain | 23007 | |
16 | H. U. de León | León | Spain | 24008 | |
17 | H. Arnau de Vilanova | Lleida | Spain | 25198 | |
18 | H. Lucus Augusti | Lugo | Spain | 27003 | |
19 | H. La Princesa | Madrid | Spain | 28006 | |
20 | Sanitas La Zarzuela | Madrid | Spain | 28023 | |
21 | H. Central de la Defensa Gómez | Madrid | Spain | 28047 | |
22 | H. Puerta de Hierro | Majadahonda, Madrid | Spain | 28222 | |
23 | H. de Mataró | Mataró, Barcelona | Spain | 8304 | |
24 | H. de Mendaro | Mendaro, Guipúzcoa | Spain | 20850 | |
25 | H. Morales Meseguer | Murcia | Spain | 30008 | |
26 | H. Virgen de la Arrixaca | Murcia | Spain | 30120 | |
27 | Consulta Privada | Málaga | Spain | 29002 | |
28 | Consulta privada Merelles Otero | Ourense | Spain | 32003 | |
29 | Consulta Privada | Ourense | Spain | 32003 | |
30 | H. Río Carrión | Palencia | Spain | 34005 | |
31 | H. Son Llatzer | Palma de Mallorca | Spain | 7198 | |
32 | H. de Navarra | Pamplona | Spain | 31008 | |
33 | H. Comarcal de la Vega Baja | San Bartolomé, Alicante | Spain | 3314 | |
34 | H. Moises Broggi | Sant Joan Despí, Barcelona | Spain | 8970 | |
35 | H. Marqués de Valdecilla | Santander | Spain | 39008 | |
36 | H. Álvarez-Buylla | Santullano, Asturias | Spain | 33619 | |
37 | H. Virgen de la Macarena | Sevilla | Spain | 41009 | |
38 | H. Virgen del Valle | Toledo | Spain | 45071 | |
39 | H. de Torrejón | Torrejón De Ardoz, Madrid | Spain | 28850 | |
40 | Consulta Privada | Valencia | Spain | 46005 | |
41 | H. General de Valencia | Valencia | Spain | 46014 | |
42 | Hospital La Fe | Valencia | Spain | 46026 | |
43 | H. Virgen de la Concha | Zamora | Spain | 49022 | |
44 | H. Clínico Lozano Blesa | Zaragoza | Spain | 50009 | |
45 | H. Miguel Servet | Zaragoza | Spain | 50009 |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
- Study Chair: Mireia canals, (+34) 93 404 58 77, mireia.canals@boehringer-ingelheim.com
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- 1160-0297
Study Results
Participant Flow
Recruitment Details | This was a non-Interventional, cross-sectional study to describe NOACs management in elderly patients with non-valvular atrial fibrillation (NVAF) in Spain. RE-BELD Study. |
---|---|
Pre-assignment Detail | All subjects were screened for eligibility prior to participation in the study. Study visit was a routine visit, one of those visits already scheduled in order to follow up the patients' NVAF (Non-Valvular Atrial Fibrillation). Patients were considered included when they agreed to participate in the study and signed the informed consent form. |
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
Period Title: Overall Study | ||||
STARTED | 192 | 76 | 166 | 66 |
COMPLETED | 192 | 76 | 166 | 66 |
NOT COMPLETED | 0 | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban | Total |
---|---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Total of all reporting groups |
Overall Participants | 192 | 76 | 166 | 66 | 500 |
Age (Years) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [Years] |
80.83
(4.50)
|
80.89
(4.64)
|
82.29
(4.90)
|
82.02
(4.80)
|
81.48
(4.73)
|
Sex: Female, Male (Count of Participants) | |||||
Female |
77
40.1%
|
46
60.5%
|
94
56.6%
|
33
50%
|
250
50%
|
Male |
115
59.9%
|
30
39.5%
|
72
43.4%
|
33
50%
|
250
50%
|
Race and Ethnicity Not Collected (Count of Participants) | |||||
Count of Participants [Participants] |
0
0%
|
||||
Weight (Kg) (Kilogram (kg)) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [Kilogram (kg)] |
76.33
(11.53)
|
73.23
(13.57)
|
74.63
(13.40)
|
71.59
(12.41)
|
74.52
(12.75)
|
Weight categorical (Count of Participants) | |||||
≤60 kg |
13
6.8%
|
12
15.8%
|
23
13.9%
|
14
21.2%
|
62
12.4%
|
>60 kg |
130
67.7%
|
58
76.3%
|
132
79.5%
|
49
74.2%
|
369
73.8%
|
Height (centimeter (cm)) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [centimeter (cm)] |
163.86
(8.28)
|
160.88
(8.88)
|
162.64
(9.61)
|
162.93
(7.75)
|
162.77
(8.86)
|
Body Mass Index (kilogram/meter^2 (kg/m^2)) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [kilogram/meter^2 (kg/m^2)] |
28.58
(4.06)
|
28.13
(4.77)
|
28.32
(4.71)
|
27.46
(3.88)
|
28.27
(4.42)
|
Body mass index categorical (BMI cat) (Count of Participants) | |||||
Underweight: BMI< 18.5 kg/m2 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Normal weight: 18.5 kg m2≤ BMI≤ 25 kg/m2 |
25
13%
|
16
21.1%
|
36
21.7%
|
12
18.2%
|
89
17.8%
|
Overweight: 25 kg/m2< BMI≤ 30 kg/m2 |
61
31.8%
|
31
40.8%
|
55
33.1%
|
21
31.8%
|
168
33.6%
|
Obese: 30 kg/m2<BMI≤ 35 kg/m2 |
33
17.2%
|
17
22.4%
|
33
19.9%
|
9
13.6%
|
92
18.4%
|
Severely Obese: BMI> 35 kg/m2 |
8
4.2%
|
3
3.9%
|
12
7.2%
|
2
3%
|
25
5%
|
Caregiver (Count of Participants) | |||||
No |
93
48.4%
|
41
53.9%
|
78
47%
|
39
59.1%
|
251
50.2%
|
Yes |
76
39.6%
|
30
39.5%
|
82
49.4%
|
24
36.4%
|
212
42.4%
|
Place where patient is living (Count of Participants) | |||||
Home alone |
17
8.9%
|
19
25%
|
23
13.9%
|
10
15.2%
|
69
13.8%
|
At home with partner/other family member/a friend |
147
76.6%
|
52
68.4%
|
119
71.7%
|
45
68.2%
|
363
72.6%
|
Other's home (e.g. family member's) |
15
7.8%
|
1
1.3%
|
17
10.2%
|
9
13.6%
|
42
8.4%
|
Nursing home |
8
4.2%
|
0
0%
|
5
3%
|
2
3%
|
15
3%
|
Smoking habit (Count of Participants) | |||||
Ex-smoker |
66
34.4%
|
17
22.4%
|
43
25.9%
|
19
28.8%
|
145
29%
|
Smoker |
6
3.1%
|
1
1.3%
|
4
2.4%
|
1
1.5%
|
12
2.4%
|
Non-smoker |
111
57.8%
|
57
75%
|
116
69.9%
|
45
68.2%
|
329
65.8%
|
Alcohol consumption (Count of Participants) | |||||
Casual or non-consumer |
149
77.6%
|
66
86.8%
|
134
80.7%
|
56
84.8%
|
405
81%
|
Habitual |
19
9.9%
|
6
7.9%
|
13
7.8%
|
3
4.5%
|
41
8.2%
|
Abuse |
0
0%
|
0
0%
|
1
0.6%
|
1
1.5%
|
2
0.4%
|
Dependence |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
Title | Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Current NOAC Dose According to Sex |
---|---|
Description | Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to sex is reported. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. |
Arm/Group Title | Sex: Male | Sex: Female |
---|---|---|
Arm/Group Description | This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). | This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). |
Measure Participants | 250 | 250 |
Current NOAC: Dabigatran (110 mg BID and 150 mg BID patients) |
115
59.9%
|
77
101.3%
|
Current NOAC: Rivaroxaban (15 mg QD and 20 mg QD patients) |
30
15.6%
|
46
60.5%
|
Current NOAC: Apixaban (2.5 mg BID and 5 mg BID patients) |
72
37.5%
|
94
123.7%
|
Current NOAC: Edoxaban (30 mg QD and 60 mg QD patients) |
33
17.2%
|
33
43.4%
|
Dabigatran 110 mg BID |
56
29.2%
|
41
53.9%
|
Dabigatran 150 mg BID |
59
30.7%
|
36
47.4%
|
Rivaroxaban 15 mg QD |
8
4.2%
|
23
30.3%
|
Rivaroxaban 20 mg QD |
22
11.5%
|
23
30.3%
|
Apixaban 2.5 mg BID |
31
16.1%
|
43
56.6%
|
Apixaban 5 mg BID |
41
21.4%
|
51
67.1%
|
Edoxaban 30 mg QD |
13
6.8%
|
18
23.7%
|
Edoxaban 60 mg QD |
20
10.4%
|
15
19.7%
|
Title | Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Sex |
---|---|
Description | Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to sex is reported. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. |
Arm/Group Title | Sex: Male | Sex: Female |
---|---|---|
Arm/Group Description | This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). | This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). |
Measure Participants | 250 | 250 |
Mean (Standard Deviation) [Years] |
2.43
(2.19)
|
2.22
(1.83)
|
Title | Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Age (Categorical) |
---|---|
Description | Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to patients' age is reported. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. |
Arm/Group Title | Age: 75-79 Years | Age: 80-84 Years | Age: ≥85 Years |
---|---|---|---|
Arm/Group Description | This arm included all patients aged between 75-79 years who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). | This arm included all patients aged between 80-84 years who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). | This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). |
Measure Participants | 210 | 152 | 138 |
Current NOAC: Dabigatran (110 mg BID and 150 mg BID patients) |
93
48.4%
|
59
77.6%
|
40
24.1%
|
Current NOAC: Rivaroxaban (15 mg QD and 20 mg QD patients) |
34
17.7%
|
23
30.3%
|
19
11.4%
|
Current NOAC: Apixaban (2.5 mg BID and 5 mg BID patients) |
59
30.7%
|
48
63.2%
|
59
35.5%
|
Current NOAC: Edoxaban (30 mg QD and 60 mg QD patients) |
24
12.5%
|
22
28.9%
|
20
12%
|
Dabigatran 110 mg BID |
22
11.5%
|
39
51.3%
|
36
21.7%
|
Dabigatran 150 mg BID |
71
37%
|
20
26.3%
|
4
2.4%
|
Rivaroxaban 15 mg QD |
10
5.2%
|
9
11.8%
|
12
7.2%
|
Rivaroxaban 20 mg QD |
24
12.5%
|
14
18.4%
|
7
4.2%
|
Apixaban 2.5 mg BID |
16
8.3%
|
21
27.6%
|
37
22.3%
|
Apixaban 5 mg BID |
43
22.4%
|
27
35.5%
|
22
13.3%
|
Edoxaban 30 mg QD |
7
3.6%
|
11
14.5%
|
13
7.8%
|
Edoxaban 60 mg QD |
17
8.9%
|
11
14.5%
|
7
4.2%
|
Title | Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Patient's Age (Categorical) |
---|---|
Description | Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to patient's age (categorical) is reported. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. |
Arm/Group Title | Age: 75-79 Years | Age: 80-84 Years | Age: ≥85 Years |
---|---|---|---|
Arm/Group Description | This arm included all patients aged between 75-79 years who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). | This arm included all patients aged between 80-84 years who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). | This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). |
Measure Participants | 210 | 152 | 138 |
Mean (Standard Deviation) [Years] |
2.33
(2.07)
|
2.32
(1.93)
|
2.32
(2.05)
|
Title | Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to a Prior Diagnosis of Heart Failure |
---|---|
Description | Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to a prior diagnosis of heart failure is reported. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. |
Arm/Group Title | Heart Failure: No | Heart Failure: Yes |
---|---|---|
Arm/Group Description | This arm included patients who participated in the study and had no prior diagnosis of heart failure and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). | This arm included patients who participated in the study and had prior diagnosis of heart failure and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). |
Measure Participants | 316 | 184 |
Current NOAC: Dabigatran (110 mg BID and 150 mg BID patients) |
129
67.2%
|
63
82.9%
|
Current NOAC: Rivaroxaban (15 mg QD and 20 mg QD patients) |
54
28.1%
|
22
28.9%
|
Current NOAC: Apixaban (2.5 mg BID and 5 mg patients) |
96
50%
|
70
92.1%
|
Current NOAC: Edoxaban (30 mg QD and 60 mg QD patients) |
37
19.3%
|
29
38.2%
|
Dabigatran 110 mg BID |
63
32.8%
|
34
44.7%
|
Dabigatran 150 mg BID |
66
34.4%
|
29
38.2%
|
Rivaroxaban 15 mg QD |
21
10.9%
|
10
13.2%
|
Rivaroxaban 20 mg QD |
33
17.2%
|
12
15.8%
|
Apixaban 2.5 mg BID |
31
16.1%
|
43
56.6%
|
Apixaban 5 mg BID |
65
33.9%
|
27
35.5%
|
Edoxaban 30 mg QD |
16
8.3%
|
15
19.7%
|
Edoxaban 60 mg QD |
21
10.9%
|
14
18.4%
|
Title | Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to a Prior Diagnosis of Heart Failure |
---|---|
Description | Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to a prior diagnosis of heart failure is reported. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. |
Arm/Group Title | Heart Failure: No | Heart Failure: Yes |
---|---|---|
Arm/Group Description | This arm included patients who participated in the study and had no prior diagnosis of heart failure and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). | This arm included patients who participated in the study and had prior diagnosis of heart failure and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). |
Measure Participants | 316 | 184 |
Mean (Standard Deviation) [Years] |
2.27
(2.02)
|
2.41
(2.02)
|
Title | Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Coronary Artery Disease |
---|---|
Description | Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the study visit according to patients' coronary artery disease is reported. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. |
Arm/Group Title | Coronary Artery Disease: No | Coronary Artery Disease: Yes |
---|---|---|
Arm/Group Description | This arm included patients who participated in the study and had no coronary artery disease and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). | This arm included patients who participated in the study and had coronary artery disease and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). |
Measure Participants | 414 | 82 |
Current NOAC: Dabigatran (110 mg BID and 150 mg BID patients) |
156
81.3%
|
35
46.1%
|
Current NOAC: Rivaroxaban (15 mg QD and 20 mg QD patients) |
63
32.8%
|
13
17.1%
|
Current NOAC: Apixaban (2.5 mg BID and 5 mg BID patients) |
142
74%
|
21
27.6%
|
Current NOAC: Edoxaban (30 mg QD and 60 mg QD patients) |
53
27.6%
|
13
17.1%
|
Dabigatran 110 mg BID |
78
40.6%
|
19
25%
|
Dabigatran 150 mg BID |
78
40.6%
|
16
21.1%
|
Rivaroxaban 15 mg QD |
23
12%
|
8
10.5%
|
Rivaroxaban 20 mg QD |
40
20.8%
|
5
6.6%
|
Apixaban 2.5 mg BID |
62
32.3%
|
10
13.2%
|
Apixaban 5 mg BID |
80
41.7%
|
11
14.5%
|
Edoxaban 30 mg QD |
23
12%
|
8
10.5%
|
Edoxaban 60 mg QD |
30
15.6%
|
5
6.6%
|
Title | Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Coronary Artery Disease |
---|---|
Description | Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to patients' coronary artery disease is reported. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. |
Arm/Group Title | Coronary Artery Disease: No | Coronary Artery Disease: Yes |
---|---|---|
Arm/Group Description | This arm included patients who participated in the study and had no coronary artery disease and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). | This arm included patients who participated in the study and had coronary artery disease and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). |
Measure Participants | 414 | 82 |
Mean (Standard Deviation) [Years] |
2.38
(2.02)
|
2.04
(1.99)
|
Title | Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Diabetes |
---|---|
Description | Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to patients' diabetes is reported. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. |
Arm/Group Title | Diabetes: No | Diabetes: Yes |
---|---|---|
Arm/Group Description | This arm included patients who participated in the study and had no diabetes were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). | This arm included patients who participated in the study and had diabetes and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). |
Measure Participants | 346 | 154 |
Current NOAC: Dabigatran (110 mg BID and 150 mg BID patients) |
135
70.3%
|
57
75%
|
Current NOAC: Rivaroxaban (15 mg QD and 20 mg QD patients) |
51
26.6%
|
25
32.9%
|
Current NOAC: Apixaban (2.5 mg BID and 5 mg BID patients) |
113
58.9%
|
53
69.7%
|
Current NOAC: Edoxaban (30 mg QD and 60 mg QD patients) |
47
24.5%
|
19
25%
|
Dabigatran 110 mg BID |
68
35.4%
|
29
38.2%
|
Dabigatran 150 mg BID |
67
34.9%
|
28
36.8%
|
Rivaroxaban 15 mg QD |
22
11.5%
|
9
11.8%
|
Rivaroxaban 20 mg QD |
29
15.1%
|
16
21.1%
|
Apixaban 2.5 mg BID |
51
26.6%
|
23
30.3%
|
Apixaban 5 mg BID |
62
32.3%
|
30
39.5%
|
Edoxaban 30 mg QD |
21
10.9%
|
10
13.2%
|
Edoxaban 60 mg QD |
26
13.5%
|
9
11.8%
|
Title | Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Diabetes |
---|---|
Description | Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to patients' diabetes is reported. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. |
Arm/Group Title | Diabetes: No | Diabetes: Yes |
---|---|---|
Arm/Group Description | This arm included patients who participated in the study and had no diabetes were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). | This arm included patients who participated in the study and had diabetes and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). |
Measure Participants | 346 | 154 |
Mean (Standard Deviation) [Years] |
2.39
(2.00)
|
2.17
(2.07)
|
Title | Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Chronic Kidney Disease |
---|---|
Description | Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to patients' chronic kidney disease is reported. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. |
Arm/Group Title | Chronic Kidney Disease: No | Chronic Kidney Disease: Yes |
---|---|---|
Arm/Group Description | This arm included patients who participated in the study and had no chronic kidney disease were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). | This arm included patients who participated in the study and had chronic kidney disease and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). |
Measure Participants | 408 | 92 |
Current NOAC: Dabigatran (110 mg BID and 150 mg BID patients) |
166
86.5%
|
26
34.2%
|
Current NOAC: Rivaroxaban (15 mg QD and 20 mg QD patients) |
64
33.3%
|
12
15.8%
|
Current NOAC: Apixaban (2.5 mg BID and 5 mg BID patients) |
130
67.7%
|
36
47.4%
|
Current NOAC: Edoxaban (30 mg QD and 60 mg QD patients) |
48
25%
|
18
23.7%
|
Dabigatran 110 mg BID |
76
39.6%
|
21
27.6%
|
Dabigatran 150 mg BID |
90
46.9%
|
5
6.6%
|
Rivaroxaban 15 mg QD |
19
9.9%
|
12
15.8%
|
Rivaroxaban 20mg QD |
45
23.4%
|
0
0%
|
Apixaban 2.5 mg BID |
43
22.4%
|
31
40.8%
|
Apixaban 5 mg BID |
87
45.3%
|
5
6.6%
|
Edoxaban 30 mg QD |
17
8.9%
|
14
18.4%
|
Edoxaban 60 mg QD |
31
16.1%
|
4
5.3%
|
Title | Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Chronic Kidney Disease |
---|---|
Description | Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to patients' chronic kidney disease is reported. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. |
Arm/Group Title | Chronic Kidney Disease: No | Chronic Kidney Disease: Yes |
---|---|---|
Arm/Group Description | This arm included patients who participated in the study and had no chronic kidney disease were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). | This arm included patients who participated in the study and had chronic kidney disease and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). |
Measure Participants | 408 | 92 |
Mean (Standard Deviation) [Years] |
2.34
(2.05)
|
2.25
(1.89)
|
Title | Serum Creatinine Concentration From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
---|---|
Description | Serum creatinine concentration from the last available blood sample analysis was retrieved from patients' medical records. Serum creatinine concentration from the last available blood sample analysis according to current NOAC type is reported. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. |
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
Measure Participants | 159 | 63 | 122 | 47 |
Mean (Standard Deviation) [milligram/deciliter (mg/dl)] |
1.00
(0.23)
|
1.05
(0.29)
|
1.15
(0.41)
|
1.14
(0.39)
|
Title | Creatinine Clearance From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
---|---|
Description | Results from the last available blood sample analysis from patients' medical records were used to retrieve the creatinine clearance (CrCl). These results were directly collected in the Electronic Case Report Form (eCRF). In cases where CrCl was not available in patients's medical record but serum creatinine was available, CrCl was estimated using Cockcroft-Gault formula: CrCl = (140 - Age(years)) x Weight (kilogram) x [0.85 if female] / 72 x [Serum Creatinine (milligram/deciliterL)] Reported are Crcl values which are calculated according to: Cockcroft-Gault formula and CrCl values directly collected in the eCRF Cockcroft-Gault formula only Directly collected in the eCRF |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. |
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
Measure Participants | 141 | 71 | 156 | 46 |
CrCl calculated by Cockcroft-Gault formula and CrCl values directly collected in the eCRF |
63.50
(18.49)
|
55.42
(17.59)
|
54.45
(18.65)
|
53.04
(18.40)
|
Calculated by Cockcroft-Gault formula only |
62.72
(18.82)
|
54.59
(17.79)
|
53.77
(19.35)
|
52.83
(18.84)
|
Directly collected in the eCRF |
66.27
(17.27)
|
59.98
(16.47)
|
56.30
(16.69)
|
53.59
(17.69)
|
Title | Number of Participants in Each Category of Creatinine Clearance Range From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
---|---|
Description | Results from the last available blood sample analysis from patients' medical records were used to retrieve the creatinine clearance (CrCl). These results were directly collected in the Electronic Case Report Form (eCRF). In cases where CrCl was not available in patients' medical record but serum creatinine was available, CrCl was estimated using Cockcroft-Gault formula: CrCl = (140 - Age(years)) x Weight (kilogram) x [0.85 if female] / 72 x [Serum Creatinine (milligram/deciliterL)] The number of participants for each of the following creatinine clearance (CrCl) ranges is reported: CrCl ≥90: Kidney damage with normal or increased glomerular filtration rate (GFR) CrCl 60-89: Kidney damage with mild decreased GFR CrCl 30-59: Moderate decrease in GFR CrCl 15-29: Severe decrease in GFR CrCl <15: Kidney failure |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. |
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
Measure Participants | 141 | 71 | 156 | 63 |
<15 ml/min/1.73m^2 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
15-29 ml/min/1.73m^2 |
0
0%
|
3
3.9%
|
10
6%
|
7
10.6%
|
30-59 ml/min/1.73m^2 |
72
37.5%
|
41
53.9%
|
92
55.4%
|
37
56.1%
|
60-89 ml/min/1.73m^2 |
55
28.6%
|
25
32.9%
|
46
27.7%
|
18
27.3%
|
≥90 ml/min/1.73m^2 |
14
7.3%
|
2
2.6%
|
8
4.8%
|
1
1.5%
|
Title | Aspartate Aminotransferase (AST) Concentration From the Last Available Blood Sample According to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
---|---|
Description | Results from the last available blood sample analysis from patients' medical records were used to retrieve AST concentration. AST concentration from the last available blood sample according to non-vitamin K antagonist oral anticoagulant (NOAC) type is reported. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. |
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
Measure Participants | 128 | 62 | 138 | 59 |
Mean (Standard Deviation) [international units per liter (IU/L)] |
24.13
(11.34)
|
21.60
(7.43)
|
25.57
(16.01)
|
20.81
(8.58)
|
Title | Alanine Aminotransferase (ALT) From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
---|---|
Description | Results from the last available blood sample analysis from patients's medical records were used to retrieve ALT concentration. ALT concentration from the last available blood sample according to NOAC type is reported. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. |
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
Measure Participants | 127 | 66 | 143 | 62 |
Mean (Standard Deviation) [units per liter (UI/L)] |
22.38
(13.66)
|
18.28
(8.95)
|
21.52
(17.81)
|
20.15
(20.76)
|
Title | Bilirubin Concentration From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
---|---|
Description | Results from the last available blood sample analysis from patients's medical records were used to retrieve bilirubin concentration. Bilirubin concentration from the last available blood sample according to NOAC type is reported.Results from the last available blood sample analysis from patients' medical records were used to retrieve bilirubin concentration. Bilirubin concentration from the last available blood sample according to NOAC type is reported. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. |
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
Measure Participants | 103 | 53 | 119 | 45 |
Mean (Standard Deviation) [milligram/deciliter (mg/dl)] |
0.83
(0.47)
|
0.79
(0.51)
|
0.74
(0.47)
|
0.75
(0.37)
|
Title | Haemoglobin Concentration From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
---|---|
Description | Results from the last available blood sample analysis from patients' medical records were used to retrieve haemoglobin concentration. Haemoglobin concentration from the last available blood sample according to NOAC type is reported. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. |
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
Measure Participants | 181 | 75 | 165 | 64 |
Mean (Standard Deviation) [gram/deciliter (g/dl)] |
13.23
(1.66)
|
13.37
(1.61)
|
12.99
(1.90)
|
13.17
(1.92)
|
Title | Platelet Levels From the Last Available Blood Sample According to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
---|---|
Description | Results from the last available blood sample analysis from patients's medical records were used to retrieve platelet levels. Platelet levels from the last available blood sample according to NOAC type is reported. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. |
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
Measure Participants | 174 | 73 | 160 | 64 |
Mean (Standard Deviation) [x 10^3/microliter (μL)] |
203.37
(60.50)
|
222.07
(77.13)
|
215.59
(81.48)
|
189.45
(68.80)
|
Title | Number of Patients in Each Category of Serum Creatinine, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin, Hemoglobin and Platelet Levels According to Current Non-vitamin K Antagonist Oral (NOAC) Type |
---|---|
Description | Results from the last available blood sample analysis from patients' medical records were used to retrieve serum creatinine, ALT, AST, bilirubin, hemoglobin concentration and platelet levels. For each reported laboratory parameter the values were categorized in two categories: Serum creatinine: Normal value : 0.6-1.2 mg/dl in males and 0.5-1.1 mg/dl in females High/low value ALT: Normal values: 7-55 units per liter (UI/L) High/low values AST: Normal values: 8-48 UI/L High/low values Bilirubin: Normal values: 0.2-1.2 milligram per deciliter (mg/dl) High/low values Haemoglobin: Normal values: 12-18 gram/deciliter (g/dL) High/low values Platelets: Normal values: 150-450 x10^3/µL High/low values |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. |
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
Measure Participants | 192 | 76 | 166 | 66 |
Normal levels |
132
68.8%
|
44
57.9%
|
72
43.4%
|
32
48.5%
|
High/low levels |
27
14.1%
|
19
25%
|
50
30.1%
|
15
22.7%
|
Normal levels |
122
63.5%
|
61
80.3%
|
127
76.5%
|
59
89.4%
|
High/low levels |
6
3.1%
|
1
1.3%
|
11
6.6%
|
0
0%
|
Normal levels |
121
63%
|
65
85.5%
|
133
80.1%
|
59
89.4%
|
High/low levels |
6
3.1%
|
1
1.3%
|
10
6%
|
3
4.5%
|
Normal levels |
91
47.4%
|
46
60.5%
|
109
65.7%
|
41
62.1%
|
High/low levels |
12
6.3%
|
7
9.2%
|
10
6%
|
4
6.1%
|
Normal levels |
143
74.5%
|
63
82.9%
|
121
72.9%
|
50
75.8%
|
High/low levels |
38
19.8%
|
12
15.8%
|
44
26.5%
|
14
21.2%
|
Normal levels |
140
72.9%
|
65
85.5%
|
128
77.1%
|
48
72.7%
|
High/low levels |
34
17.7%
|
8
10.5%
|
32
19.3%
|
16
24.2%
|
Title | Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Years Since NVAF Diagnosis According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
---|---|
Description | The number of years since NVAF diagnosis was obtained from number of years between date of NVAF diagnosis and date of study visit. The date of NVAF diagnosis was retrieved from patient's medical records. The number of years since NVAF diagnosis and date of study visit is reported for: All patients; Patients treated previously with vitamin K antagonists (VKA); Patients treated with NOAC as first anticoagulant . |
Time Frame | At the single study visit (day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. |
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
Measure Participants | 192 | 76 | 165 | 66 |
All patients |
4.78
(4.26)
|
5.85
(4.70)
|
6.01
(6.54)
|
5.63
(4.99)
|
Patients treated previously with VKA |
6.30
(4.59)
|
7.95
(4.87)
|
7.60
(5.43)
|
7.59
(4.94)
|
Patients treated with NOAC as first anticoagulant |
2.79
(2.71)
|
3.52
(3.21)
|
3.95
(7.28)
|
1.72
(1.74)
|
Title | Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Patients in Each Category of NVAF Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
---|---|
Description | NVAF was categorized in four categories: Persistent; Long standing persistent; Permanent; Paroxysmal. |
Time Frame | At the single study visit (day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. |
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
Measure Participants | 189 | 71 | 160 | 63 |
Persistent |
32
16.7%
|
11
14.5%
|
31
18.7%
|
12
18.2%
|
Long standing persistent |
21
10.9%
|
3
3.9%
|
10
6%
|
5
7.6%
|
Permanent |
99
51.6%
|
26
34.2%
|
66
39.8%
|
36
54.5%
|
Paroxysmal |
37
19.3%
|
31
40.8%
|
53
31.9%
|
10
15.2%
|
Title | Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Patients in Each Category of EHRA Scale for Atrial Fibrillation (AF) Related Symptoms According to Current NOAC Type |
---|---|
Description | The European Heart Rhythm Association (EHRA) score of atrial fibrillation is a classification system for the extent of atrial fibrillation. It places patients in one of five categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina. The EHRA categories are the following: 1-no symptoms 2a-mild symptoms; normal daily activity not affected. 2b-moderate symptoms; normal daily activity not affected. 3-severe symptoms; normal daily activity affected. 4-disabling; normal daily activity discontinued. |
Time Frame | At the single study visit (day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. |
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
Measure Participants | 188 | 69 | 157 | 62 |
1-none |
47
24.5%
|
25
32.9%
|
52
31.3%
|
17
25.8%
|
2a-mild |
83
43.2%
|
30
39.5%
|
70
42.2%
|
31
47%
|
2b-moderate |
45
23.4%
|
11
14.5%
|
28
16.9%
|
11
16.7%
|
3-severe |
10
5.2%
|
3
3.9%
|
6
3.6%
|
3
4.5%
|
4-disabling |
3
1.6%
|
0
0%
|
1
0.6%
|
0
0%
|
Title | Number of Patients in Each Category of Cardioversion, Ablation, Coronary Interventions and Pacemaker Carrier According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
---|---|
Description | Number of patients with (category Yes) and without (category No) cardioversion, ablation, coronary interventions and pacemaker carrier according to current NOAC type is reported. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. |
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
Measure Participants | 192 | 76 | 166 | 66 |
No |
171
89.1%
|
70
92.1%
|
151
91%
|
57
86.4%
|
Yes |
16
8.3%
|
6
7.9%
|
14
8.4%
|
9
13.6%
|
No |
178
92.7%
|
75
98.7%
|
160
96.4%
|
64
97%
|
Yes |
11
5.7%
|
1
1.3%
|
6
3.6%
|
2
3%
|
No |
167
87%
|
65
85.5%
|
148
89.2%
|
60
90.9%
|
Yes |
22
11.5%
|
11
14.5%
|
17
10.2%
|
5
7.6%
|
No |
166
86.5%
|
67
88.2%
|
151
91%
|
58
87.9%
|
Yes |
23
12%
|
9
11.8%
|
15
9%
|
8
12.1%
|
Title | Number of Patients in Each Category of Coronary Interventions According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
---|---|
Description | Number of patients in each category of coronary interventions according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported. Coronary interventions were categorized in: Percutaneous coronary intervention and Coronary artery bypass grafting. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Participants of FAS who underwent coronary interventions. |
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
Measure Participants | 22 | 11 | 17 | 5 |
Percutaneous coronary intervention |
19
9.9%
|
9
11.8%
|
14
8.4%
|
4
6.1%
|
Coronary artery bypass grafting |
3
1.6%
|
2
2.6%
|
3
1.8%
|
1
1.5%
|
Title | Clinical Risk Factors: Number of Patients in Each Category of Heart Failure, Coronary Artery Disease, Sleep Apnoea-hypopnoea Syndrome, Hypertension and Hyperlipidaemia According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
---|---|
Description | Number of patients in each category of heart failure, coronary artery disease, sleep apnoea-hypopnoea syndrome, hypertension and hyperlipidaemia according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported. Heart failure, coronary artery disease, sleep apnoea-hypopnoea syndrome, hypertension and hyperlipidaemia were categorized in the following two categories: No; Yes. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. |
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
Measure Participants | 192 | 76 | 166 | 66 |
No |
129
67.2%
|
54
71.1%
|
96
57.8%
|
37
56.1%
|
Yes |
63
32.8%
|
22
28.9%
|
70
42.2%
|
29
43.9%
|
No |
156
81.3%
|
63
82.9%
|
142
85.5%
|
53
80.3%
|
Yes |
35
18.2%
|
13
17.1%
|
21
12.7%
|
13
19.7%
|
No |
170
88.5%
|
70
92.1%
|
152
91.6%
|
57
86.4%
|
Yes |
19
9.9%
|
6
7.9%
|
11
6.6%
|
9
13.6%
|
No |
46
24%
|
13
17.1%
|
22
13.3%
|
7
10.6%
|
Yes |
146
76%
|
63
82.9%
|
144
86.7%
|
59
89.4%
|
No |
76
39.6%
|
28
36.8%
|
68
41%
|
17
25.8%
|
Yes |
116
60.4%
|
48
63.2%
|
97
58.4%
|
49
74.2%
|
Title | Clinical Risk Factors: Number of Heart Failure Patients in Each Category of New York Heart Association (NYHA) Classification According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
---|---|
Description | The NYHA provides a simple way of classifying the extent of heart failure and it has 4 categories: A - No objective evidence of cardiovascular disease B - Objective evidence of minimal cardiovascular disease C - Objective evidence of moderately severe cardiovascular disease D - Objective evidence of severe cardiovascular disease Number of heart failure patients in each category of New York Heart Association (NYHA) classification according to current NOAC type is reported. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Participants of FAS with heart failure. NYHA classification for heart failure patients is missing. |
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
Measure Participants | 61 | 20 | 61 | 22 |
A - No objective evidence of cardiovascular disease |
2
1%
|
0
0%
|
3
1.8%
|
0
0%
|
B - Objective evidence of minimal cardiovascular disease |
39
20.3%
|
12
15.8%
|
25
15.1%
|
8
12.1%
|
C - Objective evidence of moderately severe cardiovascular disease |
18
9.4%
|
6
7.9%
|
29
17.5%
|
12
18.2%
|
D - Objective evidence of severe cardiovascular disease |
2
1%
|
2
2.6%
|
4
2.4%
|
2
3%
|
Title | Clinical Risk Factors: Left Ventricular Ejection Fraction According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
---|---|
Description | Left ventricular ejection fraction (LVEF) according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported. LVEF was obtained from the patients' medical records. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. |
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
Measure Participants | 181 | 58 | 130 | 57 |
Mean (Standard Deviation) [percent ejection fraction (%)] |
59.47
(9.66)
|
59.43
(10.45)
|
58.85
(12.27)
|
57.91
(12.57)
|
Title | Age-adjusted Charlson Comorbidity Index Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
---|---|
Description | The Charlson Comorbidity Index is a method of categorizing comorbidities of patients based on the International Classification of Diseases (ICD) diagnosis. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use. Up to 12 comorbidities with various weightings can result in a maximum score of 24. The minimum score is zero. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. |
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
Measure Participants | 192 | 75 | 165 | 66 |
Mean (Standard Deviation) [Score on a scale] |
5.26
(1.74)
|
5.39
(1.63)
|
5.99
(2.04)
|
6.27
(2.41)
|
Title | Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
---|---|
Description | Number of patients with (Yes) and without (No) the comorbidities which were included in the Charlson Comorbidity Index according to current NOAC type is reported. The comorbidities which were included in the Charlson Comorbidity Index were the following: Myocardial infarction Congestive heart failure Peripheral vascular disease Cerebrovascular disease Dementia Chronic Obstructive Pulmonary Disease (COPD) Connective tissue disease Peptic ulcer disease Liver disease (No/Mild/Moderate to severe) Diabetes mellitus (No/Uncomplicated/End-organ damage) Hemiplegia Moderate to severe renal disease Solid Tumor (No/Localized/Metastatic) Leukaemia Lymphoma Acquired Immune Deficiency Syndrome (AIDS). |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. |
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
Measure Participants | 192 | 76 | 166 | 66 |
Myocardial infarction; No |
176
91.7%
|
65
85.5%
|
147
88.6%
|
55
83.3%
|
Myocardial infarction; Yes |
16
8.3%
|
11
14.5%
|
18
10.8%
|
11
16.7%
|
Congestive heart failure: No |
129
67.2%
|
55
72.4%
|
96
57.8%
|
38
57.6%
|
Congestive heart failure: Yes |
63
32.8%
|
21
27.6%
|
70
42.2%
|
28
42.4%
|
Peripheral vascular disease: No |
172
89.6%
|
70
92.1%
|
151
91%
|
59
89.4%
|
Peripheral vascular disease: Yes |
20
10.4%
|
5
6.6%
|
15
9%
|
7
10.6%
|
Cerebrovascular disease: No |
153
79.7%
|
63
82.9%
|
133
80.1%
|
57
86.4%
|
Cerebrovascular disease: Yes |
39
20.3%
|
13
17.1%
|
33
19.9%
|
9
13.6%
|
Dementia: No |
188
97.9%
|
72
94.7%
|
153
92.2%
|
60
90.9%
|
Dementia: Yes |
4
2.1%
|
4
5.3%
|
13
7.8%
|
6
9.1%
|
COPD: No |
161
83.9%
|
66
86.8%
|
141
84.9%
|
54
81.8%
|
COPD: Yes |
31
16.1%
|
10
13.2%
|
24
14.5%
|
12
18.2%
|
Connective tissue disease: No |
189
98.4%
|
76
100%
|
164
98.8%
|
66
100%
|
Connective tissue disease: Yes |
3
1.6%
|
0
0%
|
2
1.2%
|
0
0%
|
Peptic ulcer disease: No |
187
97.4%
|
74
97.4%
|
156
94%
|
65
98.5%
|
Peptic ulcer disease: Yes |
5
2.6%
|
2
2.6%
|
10
6%
|
1
1.5%
|
Liver disease: No |
190
99%
|
74
97.4%
|
161
97%
|
65
98.5%
|
Liver disease: Mild |
2
1%
|
2
2.6%
|
5
3%
|
1
1.5%
|
Liver disease: Moderate to severe |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Diabetes mellitus: No |
135
70.3%
|
51
67.1%
|
113
68.1%
|
47
71.2%
|
Diabetes mellitus: Uncomplicated |
48
25%
|
18
23.7%
|
36
21.7%
|
11
16.7%
|
Diabetes mellitus: End-organ damage |
9
4.7%
|
7
9.2%
|
17
10.2%
|
8
12.1%
|
Hemiplegia: No |
191
99.5%
|
76
100%
|
164
98.8%
|
62
93.9%
|
Hemiplegia: Yes |
1
0.5%
|
0
0%
|
2
1.2%
|
4
6.1%
|
Moderate to severe renal disease: No |
166
86.5%
|
64
84.2%
|
130
78.3%
|
48
72.7%
|
Moderate to severe renal disease: Yes |
26
13.5%
|
12
15.8%
|
36
21.7%
|
18
27.3%
|
Solid tumor: No |
178
92.7%
|
69
90.8%
|
148
89.2%
|
57
86.4%
|
Solid tumor: Localized |
13
6.8%
|
7
9.2%
|
16
9.6%
|
7
10.6%
|
Solid tumor: Metastatic |
1
0.5%
|
0
0%
|
2
1.2%
|
2
3%
|
Leukaemia: No |
192
100%
|
76
100%
|
166
100%
|
66
100%
|
Leukaemia: Yes |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Lymphoma: No |
192
100%
|
74
97.4%
|
165
99.4%
|
65
98.5%
|
Lymphoma: Yes |
0
0%
|
2
2.6%
|
1
0.6%
|
1
1.5%
|
AIDS: No |
192
100%
|
76
100%
|
165
99.4%
|
66
100%
|
AIDS: Yes |
0
0%
|
0
0%
|
1
0.6%
|
0
0%
|
Title | Number of Patients With and Without Any History of Thromboembolic Events, Number of Patients in Each Category of Different Types of Thromboembolic Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
---|---|
Description | Reported is the number of patients in each category of: Any history of thromboembolic events Transient Ischemic Attack (TIA) Ischemic stroke Haemorrhagic stroke Embolism systemic Deep vein thrombosis Pulmonary embolism. Any history of thromboembolic events, Transient Ischemic Attack (TIA), ischemic stroke, haemorrhagic stroke, embolism systemic, deep vein thrombosis and pulmonary embolism were categorized in the following two categories: No Yes. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. |
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
Measure Participants | 192 | 76 | 166 | 66 |
No |
153
79.7%
|
53
69.7%
|
120
72.3%
|
48
72.7%
|
Yes |
39
20.3%
|
23
30.3%
|
46
27.7%
|
18
27.3%
|
No |
180
93.8%
|
66
86.8%
|
155
93.4%
|
64
97%
|
Yes |
10
5.2%
|
9
11.8%
|
8
4.8%
|
2
3%
|
No |
173
90.1%
|
65
85.5%
|
146
88%
|
60
90.9%
|
Yes |
19
9.9%
|
7
9.2%
|
20
12%
|
5
7.6%
|
No |
189
98.4%
|
73
96.1%
|
163
98.2%
|
65
98.5%
|
Yes |
1
0.5%
|
0
0%
|
1
0.6%
|
0
0%
|
No |
191
99.5%
|
73
96.1%
|
164
98.8%
|
63
95.5%
|
Yes |
0
0%
|
0
0%
|
0
0%
|
2
3%
|
No |
190
99%
|
71
93.4%
|
162
97.6%
|
65
98.5%
|
Yes |
1
0.5%
|
2
2.6%
|
2
1.2%
|
0
0%
|
No |
190
99%
|
73
96.1%
|
161
97%
|
64
97%
|
Yes |
1
0.5%
|
1
1.3%
|
3
1.8%
|
1
1.5%
|
Title | Number of Patients in Each Category of Stable Angina, Unstable Angina, Myocardial Infarction With ST Segment Elevation and Myocardial Infarction Without ST Segment Elevation According to Current NOAC Type |
---|---|
Description | Number of patients in each category of stable angina, unstable angina, myocardial infarction with ST segment elevation and myocardial infarction without ST segment elevation according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported. Stable angina, unstable angina, myocardial infarction with ST segment elevation myocardial infarction without ST segment elevation were categorized in the following 2 categories: Yes; No. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. |
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
Measure Participants | 192 | 76 | 166 | 66 |
No |
187
97.4%
|
73
96.1%
|
161
97%
|
64
97%
|
Yes |
4
2.1%
|
0
0%
|
4
2.4%
|
1
1.5%
|
No |
190
99%
|
72
94.7%
|
158
95.2%
|
64
97%
|
Yes |
1
0.5%
|
1
1.3%
|
6
3.6%
|
1
1.5%
|
No |
183
95.3%
|
65
85.5%
|
153
92.2%
|
62
93.9%
|
Yes |
8
4.2%
|
8
10.5%
|
11
6.6%
|
3
4.5%
|
No |
183
95.3%
|
69
90.8%
|
156
94%
|
57
86.4%
|
Yes |
8
4.2%
|
4
5.3%
|
8
4.8%
|
8
12.1%
|
Title | Total Number of Thromboembolic Events, Number of Each Type of Thromboembolic Events, Number of Stable and Unstable Anginas, and Number of ST and Non-ST Myocardial Infarction According to Current NOAC Type |
---|---|
Description | Total number of thromboembolic events, number of each type of thromboembolic events, number of stable and unstable anginas, and number of ST and non-ST myocardial infarction according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. |
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
Measure Participants | 192 | 76 | 166 | 66 |
Total number of thromboembolic events |
0.29
(0.66)
|
0.54
(1.24)
|
0.49
(1.19)
|
0.36
(0.69)
|
Number of Transient Ischemic Attack (TIA) |
0.05
(0.22)
|
0.19
(0.63)
|
0.06
(0.25)
|
0.03
(0.17)
|
Number of ischemic strokes |
0.10
(0.30)
|
0.10
(0.30)
|
0.13
(0.35)
|
0.09
(0.34)
|
Number of haemorrhagic strokes |
0.01
(0.07)
|
0.00
(0.00)
|
0.01
(0.08)
|
0.00
(0.00)
|
Number of embolism systemic |
0.00
(0.00)
|
0.00
(0.00)
|
0.00
(0.00)
|
0.03
(0.17)
|
Number of deep vein thrombosis |
0.01
(0.14)
|
0.05
(0.37)
|
0.01
(0.11)
|
0.00
(0.00)
|
Number of pulmonary embolisms |
0.01
(0.07)
|
0.01
(0.12)
|
0.02
(0.13)
|
0.02
(0.12)
|
Number of stable anginas |
0.02
(0.14)
|
0.00
(0.00)
|
0.02
(0.15)
|
0.02
(0.12)
|
Number of unstable anginas |
0.01
(0.07)
|
0.01
(0.12)
|
0.12
(0.74)
|
0.02
(0.12)
|
Number of myocardial infarctions with ST segment elevation |
0.04
(0.20)
|
0.12
(0.37)
|
0.07
(0.25)
|
0.05
(0.21)
|
Number of myocardial infarctions without ST segment elevation |
0.05
(0.24)
|
0.07
(0.30)
|
0.06
(0.29)
|
0.12
(0.33)
|
Title | Number of Patients With and Without Any History of Bleeding Events and Number of Patients in Each Category of Bleeding Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
---|---|
Description | Number of patients with (category Yes) and without (category No) any history of bleeding events and number of patients in each category of the following bleeding types is reported: Intracranial Digestive Genitourinary Gingival Nasal Pulmonary Articular-muscular Conjunctival. Intracranial, digestive, genitourinary, gingival, nasal, pulmonary, articular-muscular, conjunctival were categorized in two categories: No Yes. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. |
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
Measure Participants | 192 | 76 | 166 | 66 |
No |
177
92.2%
|
68
89.5%
|
120
72.3%
|
56
84.8%
|
Yes |
14
7.3%
|
8
10.5%
|
46
27.7%
|
9
13.6%
|
No |
188
97.9%
|
74
97.4%
|
158
95.2%
|
64
97%
|
Yes |
3
1.6%
|
2
2.6%
|
7
4.2%
|
1
1.5%
|
No |
183
95.3%
|
73
96.1%
|
140
84.3%
|
62
93.9%
|
Yes |
8
4.2%
|
3
3.9%
|
26
15.7%
|
3
4.5%
|
No |
189
98.4%
|
76
100%
|
158
95.2%
|
63
95.5%
|
Yes |
2
1%
|
0
0%
|
6
3.6%
|
2
3%
|
No |
191
99.5%
|
75
98.7%
|
163
98.2%
|
64
97%
|
Yes |
0
0%
|
1
1.3%
|
2
1.2%
|
1
1.5%
|
No |
191
99.5%
|
76
100%
|
157
94.6%
|
62
93.9%
|
Yes |
0
0%
|
0
0%
|
8
4.8%
|
3
4.5%
|
No |
191
99.5%
|
76
100%
|
162
97.6%
|
64
97%
|
Yes |
0
0%
|
0
0%
|
3
1.8%
|
1
1.5%
|
No |
189
98.4%
|
76
100%
|
162
97.6%
|
65
98.5%
|
Yes |
2
1%
|
0
0%
|
3
1.8%
|
0
0%
|
No |
191
99.5%
|
73
96.1%
|
164
98.8%
|
64
97%
|
Yes |
0
0%
|
3
3.9%
|
1
0.6%
|
1
1.5%
|
Title | Total Number of Bleeding Events and Number of Each Type of Bleeding Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
---|---|
Description | Total number of bleeding events and number of bleeding events for the following bleeding types is reported: Intracranial Digestive Genitourinary Gingival Nasal Pulmonary Articular-muscular Conjunctival. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. |
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
Measure Participants | 192 | 76 | 166 | 66 |
Number of total bleeding events |
0.10
(0.42)
|
0.12
(0.36)
|
0.48
(1.01)
|
0.28
(0.82)
|
Number of intracranial events |
0.02
(0.12)
|
0.03
(0.16)
|
0.04
(0.20)
|
0.02
(0.12)
|
Number of digestive events |
0.06
(0.36)
|
0.04
(0.20)
|
0.27
(0.80)
|
0.06
(0.30)
|
Number of genitourinary events |
0.01
(0.10)
|
0.00
(0.00)
|
0.04
(0.19)
|
0.06
(0.35)
|
Number of gingival events |
0.00
(0.00)
|
0.01
(0.11)
|
0.01
(0.11)
|
0.03
(0.25)
|
Number of nasal events |
0.00
(0.00)
|
0.00
(0.00)
|
0.07
(0.36)
|
0.08
(0.37)
|
Number of pulmonary events |
0.00
(0.00)
|
0.00
(0.00)
|
0.02
(0.19)
|
0.02
(0.12)
|
Number of articular-muscular events |
0.01
(0.10)
|
0.00
(0.00)
|
0.02
(0.19)
|
0.00
(0.00)
|
Number of conjunctival events |
0.00
(0.00)
|
0.04
(0.20)
|
0.01
(0.08)
|
0.02
(0.12)
|
Title | CHA2DS2-VASc Total Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
---|---|
Description | The Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (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. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. |
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
Measure Participants | 192 | 76 | 166 | 66 |
Mean (Standard Deviation) [score on a scale] |
4.05
(1.34)
|
4.43
(1.33)
|
4.63
(1.36)
|
4.32
(1.28)
|
Title | Number of Patients on Each Category of CHA2DS2-VASc Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
---|---|
Description | The Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc) total score was categorized in three categories, according to the risk of stroke: 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) |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. |
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
Measure Participants | 192 | 76 | 166 | 66 |
Low risk |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Moderate risk |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
High risk |
192
100%
|
76
100%
|
166
100%
|
66
100%
|
Title | HAS-BLED Total Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
---|---|
Description | Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile International Normalized Ratio (INR), Elderly (>65 years), Drugs and Alcohol (HAS-BLED) score may range from 0 to 9 with 0 being the best outcome. The high scores indicate a greater risk of bleeding and a low score corresponds to a lower risk of bleeding. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. |
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
Measure Participants | 192 | 76 | 166 | 66 |
Mean (Standard Deviation) [score on a scale] |
1.99
(0.82)
|
1.64
(0.78)
|
2.01
(0.92)
|
2.06
(0.93)
|
Title | Number of Patients in Each Category of HAS-BLED Score According to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
---|---|
Description | The Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs and Alcohol (HAS-BLED) total score was categorized in three categories according to the bleeding risk: Low risk (score 0) Intermediate risk (score 1-2) High risk (score ≥3) |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. |
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
Measure Participants | 192 | 76 | 166 | 66 |
Low risk |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Intermediate risk |
147
76.6%
|
64
84.2%
|
118
71.1%
|
48
72.7%
|
High risk |
45
23.4%
|
12
15.8%
|
48
28.9%
|
18
27.3%
|
Title | Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type |
---|---|
Description | Number of patients in each category (No;Yes) of any concomitant treatments to NOAC and number of patients in each category (No; Yes) for each concomitant treatment to NOAC at study visit according to current NOAC type is reported. The concomitant treatment to non-vitamin K antagonist oral anticoagulant (NOAC) were the following: Angiotensin-Receptor Blockers (ARB) or Angiotensin Converting Enzyme inhibitors (ACE) inhibitor Beta-blocker Calcium channel blockers Diuretics Amiodarone Statin Proton pump inhibitor H2-receptor antagonist Digoxin NSAIDs (Nonsteroidal Anti-Inflammatory Drugs) Dronedarone Ketoconazole Cyclosporine Itraconazole Other antiarrhythmics |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. |
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
Measure Participants | 192 | 76 | 166 | 66 |
No |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Yes |
192
100%
|
76
100%
|
166
100%
|
66
100%
|
No |
54
28.1%
|
20
26.3%
|
57
34.3%
|
18
27.3%
|
Yes |
138
71.9%
|
56
73.7%
|
109
65.7%
|
48
72.7%
|
No |
82
42.7%
|
27
35.5%
|
54
32.5%
|
21
31.8%
|
Yes |
110
57.3%
|
49
64.5%
|
112
67.5%
|
45
68.2%
|
No |
154
80.2%
|
53
69.7%
|
136
81.9%
|
47
71.2%
|
Yes |
38
19.8%
|
23
30.3%
|
30
18.1%
|
19
28.8%
|
No |
87
45.3%
|
32
42.1%
|
56
33.7%
|
19
28.8%
|
Yes |
105
54.7%
|
44
57.9%
|
110
66.3%
|
47
71.2%
|
No |
174
90.6%
|
67
88.2%
|
146
88%
|
62
93.9%
|
Yes |
18
9.4%
|
9
11.8%
|
20
12%
|
4
6.1%
|
No |
83
43.2%
|
34
44.7%
|
77
46.4%
|
18
27.3%
|
Yes |
109
56.8%
|
42
55.3%
|
89
53.6%
|
48
72.7%
|
No |
89
46.4%
|
29
38.2%
|
58
34.9%
|
17
25.8%
|
Yes |
103
53.6%
|
47
61.8%
|
108
65.1%
|
49
74.2%
|
No |
191
99.5%
|
75
98.7%
|
162
97.6%
|
65
98.5%
|
Yes |
1
0.5%
|
1
1.3%
|
4
2.4%
|
1
1.5%
|
No |
168
87.5%
|
71
93.4%
|
153
92.2%
|
57
86.4%
|
Yes |
24
12.5%
|
5
6.6%
|
13
7.8%
|
9
13.6%
|
No |
180
93.8%
|
72
94.7%
|
155
93.4%
|
61
92.4%
|
Yes |
12
6.3%
|
4
5.3%
|
11
6.6%
|
5
7.6%
|
No |
192
100%
|
76
100%
|
163
98.2%
|
66
100%
|
Yes |
0
0%
|
0
0%
|
3
1.8%
|
0
0%
|
No |
192
100%
|
76
100%
|
166
100%
|
66
100%
|
Yes |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
No |
192
100%
|
76
100%
|
166
100%
|
66
100%
|
Yes |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
No |
192
100%
|
76
100%
|
166
100%
|
66
100%
|
Yes |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
No |
188
97.9%
|
73
96.1%
|
160
96.4%
|
65
98.5%
|
Yes |
4
2.1%
|
3
3.9%
|
6
3.6%
|
1
1.5%
|
Title | Number of Patients in Each Category of Previous Vitamin K Antagonists (VKA) Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation |
---|---|
Description | Number of patients in each category of previous Vitamin K Antagonists (VKA) treatment according to duration since the first non-vitamin K antagonist oral anticoagulant (NOAC) initiation is reported. Previous VKA treatment was categorized in 2 categories: No; Yes. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. |
Arm/Group Title | ≤4 Months | >4 Months |
---|---|---|
Arm/Group Description | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC)>4 months. |
Measure Participants | 39 | 461 |
No |
26
13.5%
|
187
246.1%
|
Yes |
13
6.8%
|
274
360.5%
|
Title | Number of Patients Treated Previously With the VKA Acenocoumarol and Number of Patients Treated Previously With the VKA Warfarin According to Duration Since the First NOAC Initiation |
---|---|
Description | Number of patients treated previously (before they were treated with non-vitamin K antagonist oral anticoagulant (NOAC)) with the Vitamin K Antagonists (VKA) acenocoumarol and number of patients treated previously with the VKA warfarin according to duration since the first NOAC initiation is reported. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Participants of FAS who previously received VKA treatment. One patient received acenocoumarol and warfarin during the study, so the total percentage is not 100%. |
Arm/Group Title | ≤4 Months | >4 Months |
---|---|---|
Arm/Group Description | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
Measure Participants | 13 | 274 |
Acenocoumarol |
13
6.8%
|
263
346.1%
|
Warfarin |
0
0%
|
12
15.8%
|
Title | Duration of Previous Vitamin K Antagonists (VKA) Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation |
---|---|
Description | Duration of treatment (in years) is reported for: All patients treated previously with Vitamin K Antagonists (VKA) (row:All patients treated previously with VKA) Patients treated only with the VKA warfarin (row: Warfarin patients) Patients treated only with the VKA acenocoumarol (row: Acenocoumarol patients) |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. |
Arm/Group Title | ≤4 Months | >4 Months |
---|---|---|
Arm/Group Description | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
Measure Participants | 13 | 274 |
Acenocoumarol patients |
3.65
(3.85)
|
3.88
(4.14)
|
Warfarin patients |
3.35
(1.94)
|
|
All patients treated previously with VKA |
3.65
(3.85)
|
3.87
(4.07)
|
Title | Duration Since Non-valvular Atrial Fibrillation (NVAF) Diagnosis Until First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation According to Duration Since the First NOAC Initiation |
---|---|
Description | Duration (in years) since non-valvular atrial fibrillation (NVAF) diagnosis until first NOAC initiation according to duration since the first NOAC initiation is reported for: All patients Patients treated previously with VKA Patients treated only with NOAC as anticoagulant (AC) |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. |
Arm/Group Title | ≤4 Months | >4 Months |
---|---|---|
Arm/Group Description | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
Measure Participants | 39 | 460 |
All patients |
1.62
(2.77)
|
3.27
(4.95)
|
Patients treated previously with VKA |
3.71
(3.70)
|
4.84
(4.79)
|
Patients treated with NOAC as first AC |
0.58
(1.30)
|
0.99
(4.27)
|
Title | First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and First NOAC Dose According to Duration Since the First NOAC Initiation |
---|---|
Description | Number of patients who received dabigatran, rivaroxaban, apixaban, edoxaban as first NOAC and number of patients who received dabigatran 110 mg BID (twice daily), dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD as first NOAC according to duration since the first NOAC initiation is reported. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. |
Arm/Group Title | ≤4 Months | >4 Months |
---|---|---|
Arm/Group Description | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
Measure Participants | 39 | 461 |
First NOAC received: Dabigatran ( 110 mg BID and 150 mg BID patients) |
23
12%
|
174
228.9%
|
First NOAC received: Rivaroxaban (15 mg QD and 20 mg QD patients) |
2
1%
|
81
106.6%
|
First NOAC received: Apixaban (2.5 mg BID and 5 mg BID patients) |
9
4.7%
|
143
188.2%
|
First NOAC received: Edoxaban (30 mg QD and 60 mg QD patients) |
5
2.6%
|
63
82.9%
|
First NOAC dose: Dabigatran 110 mg BID |
6
3.1%
|
88
115.8%
|
First NOAC dose: Dabigatran 150 mg BID |
17
8.9%
|
86
113.2%
|
First NOAC dose: Rivaroxaban 15 mg QD |
0
0%
|
30
39.5%
|
First NOAC dose: Rivaroxaban 20 mg QD |
2
1%
|
51
67.1%
|
First NOAC dose: Apixaban 2.5 mg BID |
4
2.1%
|
53
69.7%
|
First NOAC dose: Apixaban 5 mg BID |
5
2.6%
|
90
118.4%
|
First NOAC dose: Edoxaban 30 mg QD |
4
2.1%
|
26
34.2%
|
First NOAC dose: Edoxaban 60 mg QD |
1
0.5%
|
37
48.7%
|
Title | Number of Patients Who Changed (Increased and Decreased) and Did Not Change the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Dose According to Duration Since the First NOAC Initiation |
---|---|
Description | Number of patients who changed (increased and decreased) and did not change the first non-vitamin K antagonist oral anticoagulant (NOAC) dose according to duration since the first NOAC initiation is reported. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. |
Arm/Group Title | ≤4 Months | >4 Months |
---|---|---|
Arm/Group Description | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. |
Measure Participants | 39 | 461 |
No |
39
20.3%
|
427
561.8%
|
Yes (increase) |
0
0%
|
8
10.5%
|
Yes (decrease) |
0
0%
|
26
34.2%
|
Title | First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Duration (in Years) According to Duration Since the First NOAC Initiation |
---|---|
Description | Treatment duration (in years) is reported for: Patients who stopped first NOAC treatment; Patients who did not stop the first NOAC treatment. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. |
Arm/Group Title | ≤4 Months | >4 Months |
---|---|---|
Arm/Group Description | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
Measure Participants | 39 | 461 |
Patients who stopped first NOAC treatment |
0.01
|
1.60
(1.61)
|
Patients who did not stop the first NOAC treatment |
0.30
(0.03)
|
2.38
(1.93)
|
Title | Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Discontinuation According to Duration Since the First NOAC Initiation |
---|---|
Description | Reason for first NOAC treatment discontinuation was categorized in four categories: Lack of effectiveness Investigator's decision Patient's decision Adverse event |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Only patients who stopped first NOAC treatment. |
Arm/Group Title | ≤4 Months | >4 Months |
---|---|---|
Arm/Group Description | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
Measure Participants | 1 | 42 |
Lack of effectiveness |
0
0%
|
1
1.3%
|
Investigator's decision |
0
0%
|
15
19.7%
|
Patient's decision |
0
0%
|
7
9.2%
|
Adverse event |
1
0.5%
|
19
25%
|
Title | Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Change Dose According to Duration Since the First NOAC Initiation |
---|---|
Description | Reason for first NOAC treatment change was categorized in four categories: Lack of effectiveness Investigator's decision Patient's decision Adverse event |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Only patients who changed dose in first NOAC treatment. |
Arm/Group Title | ≤4 Months | >4 Months |
---|---|---|
Arm/Group Description | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
Measure Participants | 0 | 34 |
Lack of effectiveness |
2
1%
|
|
Investigator's decision |
24
12.5%
|
|
Patient's decision |
0
0%
|
|
Adverse event |
8
4.2%
|
Title | Number of Switches to a New Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Per Patient According to Duration Since the First NOAC Initiation |
---|---|
Description | Number of switches to a new non-vitamin K antagonist oral anticoagulant (NOAC) per patient according to duration since the first NOAC initiation is reported. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. |
Arm/Group Title | ≤4 Months | >4 Months |
---|---|---|
Arm/Group Description | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
Measure Participants | 39 | 461 |
Mean (Standard Deviation) [switches per patient] |
0.03
(0.16)
|
0.10
(0.35)
|
Title | Number of Patients in Each Category of Number of Switches to a New Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Per Patient According to Duration Since the First NOAC Initiation |
---|---|
Description | Number of patients based on the number of switches to a new NOAC per patient according to duration since the first NOAC initiation is reported. Number of switches to a new NOAC was categorized in 3 categories: 0 switches 1 switch 2 switches. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. |
Arm/Group Title | ≤4 Months | >4 Months |
---|---|---|
Arm/Group Description | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
Measure Participants | 39 | 461 |
0 switches |
38
19.8%
|
419
551.3%
|
1 switch |
1
0.5%
|
36
47.4%
|
2 switches |
0
0%
|
6
7.9%
|
Title | Total Number of Switches According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation |
---|---|
Description | Total number of switches according to duration since the first NOAC initiation is reported. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Participants of FAS who switched to a new NOAC. |
Arm/Group Title | ≤4 Months | >4 Months |
---|---|---|
Arm/Group Description | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
Measure Participants | 1 | 48 |
Dabigatran to Rivaroxaban |
0
|
3
|
Dabigatran to Apixaban |
0
|
9
|
Dabigatran to Edoxaban |
0
|
2
|
Rivaroxaban to Dabigatran |
0
|
0
|
Rivaroxaban to Apixaban |
1
|
10
|
Rivaroxaban to Edoxaban |
0
|
2
|
Apixaban to Dabigatran |
0
|
5
|
Apixaban to Rivaroxaban |
0
|
3
|
Apixaban to Edoxaban |
0
|
4
|
Edoxaban to Dabigatran |
0
|
4
|
Edoxaban to Rivaroxaban |
0
|
0
|
Edoxaban to Apixaban |
0
|
6
|
Title | Number of Switches in Each Category of Reason for Switch According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation |
---|---|
Description | Reason for switch was categorized in four categories: Lack of effectiveness Investigator's decision Patient's decision Adverse event |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Participants of FAS who switched to a new NOAC. |
Arm/Group Title | ≤4 Months | >4 Months |
---|---|---|
Arm/Group Description | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
Measure Participants | 1 | 48 |
Lack of effectiveness |
0
|
1
|
Investigator's decision |
0
|
17
|
Patient's decision |
0
|
7
|
Adverse event |
1
|
23
|
Title | Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Second NOAC Dose According to Duration Since the First NOAC Initiation |
---|---|
Description | Number of patients who received dabigatran, rivaroxaban, apixaban, edoxaban as second NOAC and number of patients who received dabigatran 110 mg BID (twice daily), dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD as second NOAC according to duration since the first NOAC initiation is reported. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Number of patients who stopped the first NOAC treatment and switched to a second NOAC treatment. |
Arm/Group Title | ≤4 Months | >4 Months |
---|---|---|
Arm/Group Description | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
Measure Participants | 1 | 42 |
Second NOAC received: Dabigatran (110 mg BID and 150 mg BID patients) |
0
0%
|
8
10.5%
|
Second NOAC received: Rivaroxaban (15 mg QD and 20 mg QD patients) |
0
0%
|
5
6.6%
|
Second NOAC received: Apixaban (2.5 mg BID and 5 mg BID patients) |
1
0.5%
|
21
27.6%
|
Second NOAC received: Edoxaban (30 mg QD and 60 mg QD patients) |
0
0%
|
8
10.5%
|
Second NOAC dose: Dabigatran 110 mg BID |
6
3.1%
|
|
Second NOAC dose: Dabigatran 150 mg BID |
2
1%
|
|
Second NOAC dose: Rivaroxaban 15 mg QD |
3
1.6%
|
|
Second NOAC dose: Rivaroxaban 20 mg QD |
2
1%
|
|
Second NOAC dose: Apixaban 2.5 mg BID |
0
0%
|
13
17.1%
|
Second NOAC dose: Apixaban 5 mg BID |
1
0.5%
|
8
10.5%
|
Second NOAC dose: Edoxaban 30 mg QD |
3
1.6%
|
|
Second NOAC dose: Edoxaban 60 mg QD |
5
2.6%
|
Title | Number of Patients Who Changed (Increased or Decreased) and Did Not Change the Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Dose According to Duration Since the First NOAC Initiation |
---|---|
Description | Number of patients who changed (increased or decreased) and did not change the second non-vitamin K antagonist oral anticoagulant (NOAC) dose according to duration since the first NOAC initiation is reported. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Participants of FAS who stopped the first NOAC treatment and switched to a second NOAC treatment. |
Arm/Group Title | ≤4 Months | >4 Months |
---|---|---|
Arm/Group Description | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
Measure Participants | 1 | 42 |
No |
1
0.5%
|
40
52.6%
|
Yes (increase) |
0
0%
|
1
1.3%
|
Yes (decrease) |
0
0%
|
1
1.3%
|
Title | Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Duration (in Years) According to Duration Since the First NOAC Initiation |
---|---|
Description | Second NOAC treatment duration (in years) according to duration since the first NOAC initiation is reported. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Participants of FAS who stopped second NOAC treatment. |
Arm/Group Title | ≤4 Months | >4 Months |
---|---|---|
Arm/Group Description | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months.. |
Measure Participants | 0 | 6 |
Mean (Standard Deviation) [Years] |
0.49
(0.39)
|
Title | Number of Patients in Each Category of Reason for Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Discontinuation According to Duration Since the First NOAC Initiation |
---|---|
Description | Reason for second non-vitamin K antagonist oral anticoagulant (NOAC) treatment discontinuation was categorized in four categories: Lack of effectiveness Investigator's decision Patient's decision Adverse event |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Participants of FAS who stopped second NOAC treatment. |
Arm/Group Title | ≤4 Months | >4 Months |
---|---|---|
Arm/Group Description | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
Measure Participants | 0 | 6 |
Lack of effectiveness |
0
0%
|
|
Investigator's decision |
2
1%
|
|
Patient's decision |
0
0%
|
|
Adverse event |
4
2.1%
|
Title | Number of Patients in Each Category of Reason for Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Change Dose According to Duration Since the First NOAC Initiation |
---|---|
Description | Reason for second NOAC treatment change was categorized in four categories: Lack of effectiveness Investigator's decision Patient's decision Adverse event |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Participants of FAS who changed dose in second NOAC treatment. |
Arm/Group Title | ≤4 Months | >4 Months |
---|---|---|
Arm/Group Description | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
Measure Participants | 0 | 2 |
Lack of effectiveness |
0
0%
|
|
Investigator's decision |
2
1%
|
|
Patient's decision |
0
0%
|
|
Adverse event |
0
0%
|
Title | Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Third NOAC Dose According to Duration Since the First NOAC Initiation |
---|---|
Description | Number of patients who received dabigatran, rivaroxaban, apixaban, edoxaban as third NOAC and number of patients who received dabigatran 110 mg BID (twice daily), dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD as third NOAC according to duration since the first NOAC initiation is reported. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Participants of FAS who stopped second NOAC treatment. |
Arm/Group Title | ≤4 Months | >4 Months |
---|---|---|
Arm/Group Description | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
Measure Participants | 0 | 6 |
Third NOAC received: Dabigatran |
1
0.5%
|
|
Third NOAC received: Rivaroxaban |
1
0.5%
|
|
Third NOAC received: Apixaban |
4
2.1%
|
|
Third NOAC received:Edoxaban |
0
0%
|
|
Third NOAC dose: Dabigatran 110 mg BID |
1
0.5%
|
|
Third NOAC dose: Dabigatran 150 mg BID |
0
0%
|
|
Third NOAC dose: Rivaroxaban 15 mg QD |
1
0.5%
|
|
Third NOAC dose: Rivaroxaban 20 mg QD |
0
0%
|
|
Third NOAC dose: Apixaban 2.5 mg BID |
3
1.6%
|
|
Third NOAC dose: Apixaban 5 mg BID |
1
0.5%
|
Title | Number of Patients Who Changed (Increased and Decreased) and Did Not Change the Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Dose According to Duration Since the First NOAC Initiation |
---|---|
Description | Number of patients who changed (increased and decreased) and did not change the third non-vitamin K antagonist oral anticoagulant (NOAC) dose according to duration since the first NOAC initiation is reported. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Participants of FAS who started third NOAC treatment. |
Arm/Group Title | ≤4 Months | >4 Months |
---|---|---|
Arm/Group Description | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
Measure Participants | 0 | 6 |
No |
6
3.1%
|
|
Yes (increase) |
0
0%
|
|
Yes (decrease) |
0
0%
|
Title | Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Duration (in Years) According to Duration Since the First NOAC Initiation |
---|---|
Description | Duration of third NOAC treatment for patients who stopped NOAC treatment. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Participants of FAS who stopped third NOAC treatment. No patient stopped the third NOAC treatment. |
Arm/Group Title | ≤4 Months | >4 Months |
---|---|---|
Arm/Group Description | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
Measure Participants | 0 | 0 |
Title | Number of Patients in Each Category of Reason for Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Discontinuation According to Duration Since the First NOAC Initiation |
---|---|
Description | Reason for Third NOAC treatment discontinuation was categorized in four categories: Lack of effectiveness Investigator's decision Patient's decision Adverse event |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Participants of FAS who stopped third NOAC treatment. No patient stopped the third NOAC treatment. |
Arm/Group Title | ≤4 Months | >4 Months |
---|---|---|
Arm/Group Description | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
Measure Participants | 0 | 0 |
Lack of effectiveness | ||
Investigator's decision | ||
Patient's decision | ||
Adverse event |
Title | Number of Patients in Each Category of Reason for Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Change Dose According to Duration Since the First NOAC Initiation |
---|---|
Description | Reason for Third NOAC treatment change was categorized in four categories: Lack of effectiveness Investigator's decision Patient's decision Adverse event |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Participants of FAS who changed dose in third NOAC treatment. No patients stopped the third NOAC treatment. |
Arm/Group Title | ≤4 Months | >4 Months |
---|---|---|
Arm/Group Description | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
Measure Participants | 0 | 0 |
Lack of effectiveness | ||
Investigator's decision | ||
Patient's decision | ||
Adverse event |
Title | Duration (in Years) in Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment According to Duration Since the First NOAC Initiation |
---|---|
Description | Duration (in years) in NOAC treatment is reported for: All patients (patients who received or did not receive VKA) Patients treated previously with Vitamin K Antagonists (VKA) Patients treated with NOAC as first anticoagulant |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. |
Arm/Group Title | ≤4 Months | >4 Months |
---|---|---|
Arm/Group Description | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
Measure Participants | 39 | 461 |
All patients |
0.29
(0.03)
|
2.45
(1.96)
|
Patients treated previously with VKA |
0.29
(0.03)
|
2.39
(1.98)
|
Patients treated with NOAC as first anticoagulant |
0.29
(0.03)
|
2.54
(1.94)
|
Title | Number of Patients in Each Category of Total Time in Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment According to Duration Since the First NOAC Initiation |
---|---|
Description | Number of patients in each category of total time in non-vitamin K antagonist oral anticoagulant (NOAC) treatment according to duration since the first NOAC initiation is reported. Total time in NOAC treatment was categorized in 4 categories: <1 year; 1-2 years; 2-3 years; >3 years. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. |
Arm/Group Title | ≤4 Months | >4 Months |
---|---|---|
Arm/Group Description | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
Measure Participants | 39 | 461 |
<1 year |
39
20.3%
|
149
196.1%
|
1-2 years |
0
0%
|
87
114.5%
|
2-3 years |
0
0%
|
74
97.4%
|
>3 years |
0
0%
|
151
198.7%
|
Title | Number of Patients for Each Type of Antiplatelet Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation |
---|---|
Description | Number of patients for each type of following antiplatelet treatment that the patients ever received is reported: None (reports the patients who did not receive any antiplatelet treatment) Acetyl salicylic acid Clopidogrel Prasugrel Ticlopidine Ticagrelor Cilostazol Triflusal Dipyridamole Others (other antiplatelet treatment than above mentioned). |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. |
Arm/Group Title | ≤4 Months | >4 Months |
---|---|---|
Arm/Group Description | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
Measure Participants | 39 | 461 |
None (no antiplatelet treatment received) |
35
18.2%
|
314
413.2%
|
Acetyl salicylic acid |
4
2.1%
|
124
163.2%
|
Clopidogrel |
1
0.5%
|
43
56.6%
|
Prasugrel |
0
0%
|
2
2.6%
|
Ticlopidine |
0
0%
|
1
1.3%
|
Ticagrelor |
0
0%
|
1
1.3%
|
Cilostazol |
0
0%
|
0
0%
|
Triflusal |
0
0%
|
3
3.9%
|
Dipyridamole |
0
0%
|
0
0%
|
Others (other antiplatelet treatment than listed above) |
0
0%
|
0
0%
|
Title | Number of Patients for Each Type of Antiplatelet Treatment at the Time of Study Visit According to Duration Since the First NOAC Initiation |
---|---|
Description | Number of patients for each of the following antiplatelet treatment types at the time of study visit according to duration since the first NOAC initiation is reported: None (reports the patients who did not receive any antiplatelet treatment) Acetyl salicylic acid Clopidogrel Prasugrel Ticlopidine Ticagrelor Cilostazol Triflusal Dipyridamole Others (other antiplatelet treatment than above mentioned). |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. |
Arm/Group Title | ≤4 Months | >4 Months |
---|---|---|
Arm/Group Description | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
Measure Participants | 39 | 461 |
None |
38
19.8%
|
444
584.2%
|
Acetyl salicylic acid |
0
0%
|
9
11.8%
|
Clopidogrel |
1
0.5%
|
11
14.5%
|
Prasugrel |
0
0%
|
0
0%
|
Ticlopidine |
0
0%
|
0
0%
|
Ticagrelor |
0
0%
|
1
1.3%
|
Cilostazol |
0
0%
|
0
0%
|
Triflusal |
0
0%
|
3
3.9%
|
Dipyridamole |
0
0%
|
0
0%
|
Others |
0
0%
|
0
0%
|
Title | Time in Treatment With Antiplatelet Agents (in Years) According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation |
---|---|
Description | Time in treatment with antiplatelet agents (in years) according to duration since the first NOAC initiation is reported. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. |
Arm/Group Title | ≤4 Months | >4 Months |
---|---|---|
Arm/Group Description | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
Measure Participants | 39 | 461 |
Mean (Standard Deviation) [Years] |
5.82
(1.66)
|
5.98
(7.06)
|
Title | Number of Patients in Each Score of Clinical Frailty Scale Grading at the Time of the Study Visit According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
---|---|
Description | Clinical Frailty Scale (CFS) is used commonly to assess frailty. It is a 9-point scale from 1 to 9 (1=very fit; 2=well; 3=Managing well; 4=Vulnerable; 5=Mildly frail; 6=Moderately frail; 7=Severely frail; 8=very severely frail; 9=terminally ill) that summarizes the overall level of fitness or frailty of an older adult after they had been evaluated by a health care professional. Applying the CFS to patients is quick and requires data collection by watching the patient (mobilize), inquiring about their habitual physical activity and ability. A person with a score >4 was considered frail. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. |
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
Measure Participants | 192 | 76 | 166 | 66 |
1-Very fit |
11
5.7%
|
6
7.9%
|
8
4.8%
|
0
0%
|
2-Well |
24
12.5%
|
15
19.7%
|
18
10.8%
|
9
13.6%
|
3-Managing well |
79
41.1%
|
23
30.3%
|
44
26.5%
|
24
36.4%
|
4-Vulnerable |
45
23.4%
|
11
14.5%
|
46
27.7%
|
19
28.8%
|
5-Mildly frail |
13
6.8%
|
8
10.5%
|
16
9.6%
|
7
10.6%
|
6-Moderately frail |
15
7.8%
|
10
13.2%
|
24
14.5%
|
3
4.5%
|
7-Severely frail |
4
2.1%
|
3
3.9%
|
9
5.4%
|
3
4.5%
|
8-Very severely frail |
1
0.5%
|
0
0%
|
1
0.6%
|
1
1.5%
|
9-Terminally ill |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Title | Number of Patients in Each Category Clinical Frailty Scale at the Time of the Study Visit According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type |
---|---|
Description | Clinical Frailty Scale (CFS) is used commonly to assess frailty. It is a 9-point scale from 1 to 9 (1=very fit; 2=well; 3=Managing well; 4=Vulnerable; 5=Mildly frail; 6=Moderately frail; 7=Severely frail; 8=very severely frail; 9=terminally ill) that summarizes the overall level of fitness or frailty of an older adult after they had been evaluated by a health care professional. Applying the CFS to patients is quick and requires data collection by watching the patient (mobilize), inquiring about their habitual physical activity and ability. CFS was categorized in two categories, according to this ranges: Frailty patients - CFS scoring >4 Non-frailty patients - CFS scoring ≤4 |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. |
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
Measure Participants | 192 | 76 | 166 | 66 |
Non-frailty patients (CFS scoring ≤4) |
159
82.8%
|
55
72.4%
|
116
69.9%
|
52
78.8%
|
Frailty patients (CFS scoring >4) |
33
17.2%
|
21
27.6%
|
50
30.1%
|
14
21.2%
|
Title | Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Usage at the Time of First NOAC Initiation According to Current NOAC Type |
---|---|
Description | Reason for First NOAC usage was categorized in the following two categories: Primary prevention; Secondary prevention. |
Time Frame | At the single study visit (Day 1). |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. |
Arm/Group Title | Dabigatran | Rivaroxaban | Apixaban | Edoxaban |
---|---|---|---|---|
Arm/Group Description | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
Measure Participants | 190 | 75 | 166 | 66 |
Primary prevention |
138
71.9%
|
61
80.3%
|
135
81.3%
|
54
81.8%
|
Secondary prevention |
52
27.1%
|
14
18.4%
|
31
18.7%
|
12
18.2%
|
Adverse Events
Time Frame | Information about the adverse events (AEs) was collected from the patients' medical records at the time of single study visit (Day 1). AEs collection covered a total time of 10 years. | |
---|---|---|
Adverse Event Reporting Description | Adverse events were collected and reported only for patients who received dabigatran either as first NOAC, or second NOAC or third NOAC.For rivaroxaban, apixaban and edoxaban patients' adverse events were not assessed. | |
Arm/Group Title | All Dabigatran Patients | |
Arm/Group Description | This group included all patients who received dabigatran either as first NOAC (patients who the first NOAC prescribed was dabigatran), or as second NOAC (patients who stopped the first prescribed NOAC and received dabigatran as second NOAC), or as third NOAC (patients who stopped the second prescribed NOAC and received dabigatran as third NOAC). | |
All Cause Mortality |
||
All Dabigatran Patients | ||
Affected / at Risk (%) | # Events | |
Total | 0/206 (0%) | |
Serious Adverse Events |
||
All Dabigatran Patients | ||
Affected / at Risk (%) | # Events | |
Total | 4/206 (1.9%) | |
Gastrointestinal disorders | ||
Gastrointestinal haemorrhage | 1/206 (0.5%) | |
Intestinal haemorrhage | 1/206 (0.5%) | |
Lower gastrointestinal haemorrhage | 1/206 (0.5%) | |
Nervous system disorders | ||
Transient ischaemic attack | 1/206 (0.5%) | |
Other (Not Including Serious) Adverse Events |
||
All Dabigatran Patients | ||
Affected / at Risk (%) | # Events | |
Total | 0/206 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Results Point of Contact
Name/Title | Boehringer Ingelheim, Call Center |
---|---|
Organization | Boehringer Ingelheim |
Phone | 1-800-243-0127 |
clintriage.rdg@boehringer-ingelheim.com |
- 1160-0297