To describe the direct costs related to warfarin/apixaban treatment
To describe the direct costs related to warfarin/apixaban treatment during the first 6 months of the secondary stroke prevention in NVAF patients.
Study Type
OBSERVATIONAL
Enrollment
109
Fakultní nemocnice Motol
Prague, Czechia
CHA2-DS2-VASc Score at Baseline
CHA2DS2-VASc scoring scale was used to estimate the risk of stroke and systemic emboli in participants with NVAF. CHA2DS2-VASc score was calculated based on 8 risk factors (age 65-74 years, age \>=75 years, sex category, i.e. female sex, congestive heart failure history, hypertension history, stroke/TIA/thromboembolism history, vascular disease history and diabetes mellitus history). Total CHA2DS2-VASc score ranged from 0-9 where 0= low risk and 9= high risk of stroke.
Time frame: Baseline (from retrospective data retrieved in the study)
HAS-BLED Score at Baseline
HAS-BLED scoring scale was used to estimate the risk of bleeding. HAS-BLED score was calculated based on 9 risk factors (hypertension, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age \>65 years, medication usage predisposing to bleeding and alcohol use). Total HAS-BLED score ranged from 0 to 9 where 0 = low risk and \>=3 = high risk of bleed.
Time frame: Baseline (from retrospective data retrieved in the study)
CHA2-DS2-VASc Score at Month 6
CHA2DS2-VASc scoring scale was used to estimate the risk of stroke and systemic emboli in participants with NVAF. CHA2DS2-VASc score was calculated based on 8 risk factors (age 65-74 years, age \>=75 years, sex category i.e. female sex, congestive heart failure history, hypertension history, stroke/TIA/thromboembolism history, vascular disease history and diabetes mellitus history). Total CHA2DS2-VASc score ranged from 0-9 where 0= low risk and 9= high risk of stroke.
Time frame: Month 6 (from retrospective data retrieved in the study)
HAS-BLED Score at Month 6
HAS-BLED scoring scale was used to estimate the risk of bleeding. HAS-BLED score was calculated based on 9 risk factors (hypertension, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age \>65 years, medication usage predisposing to bleeding and alcohol use). Total HAS-BLED score ranged from 0 to 9 where 0 = low risk and \>=3 = high risk of bleed.
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Time frame: Month 6 (from retrospective data retrieved in the study)
Percentage of Participants Categorized According to Number of Outpatient Visits During First 6 Months of Treatment
In this outcome measure, percentage of participants were categorized according to number of outpatient visits from 0 to 5.
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Cost of Outpatient Visits During First 6 Months of Treatment
Costs of outpatient visits were calculated for the first 6 months of treatment as the number of visits multiplied by the cost of the visit (450.0 Czech koruna \[CZK\] per visit). Costs were calculated based on the number of outpatient visits during the treatment.
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Percentage of Participants Categorized According to Number of International Normalized Ratios (INR) Measurements During First 6 Months of Treatment
INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. In this outcome measure, percentage of participants were categorized according to number of INR measurements included zero (0), 1 to 9, 10 to 19 and greater than or equal to (\>=) 20.
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Cost of INR Measurements During First 6 Months of Treatment
INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. Costs related to INR measurements, were calculated for the period of 6 months as the number of INR measurements multiplied by the cost of the INR measurement (213.0 CZK per measurement). Costs were based on the expenditure of total number of INR measurements during first 6-month treatment.
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Dosage of Warfarin and Apixaban at the Initiation of the Treatment
In this outcome measure, dosage of apixaban and warfarin used at the initiation of treatment was reported.
Time frame: Baseline (from retrospective data retrieved in the study)
Dosage of Warfarin and Apixaban During First 6 Months of Treatment
In this outcome measure, dosage of apixaban and warfarin used during first 6 months of treatment was reported.
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Cost of Medication During First 6 Months of Treatment
In this outcome measure, cost of medication, i.e., costs of apixaban and warfarin were based on the dosage of active substance and were calculated for the first 6 months of treatment (daily cost times 182.4 days), regardless of how long the individual participant treated was reported.
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Percentage of Participants Categorized According to Number of Hospital Admissions
In this outcome measure, percentage of participants were categorized according to number of hospital admissions from 0 to 3 were reported.
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Cost of Hospital Admissions During First 6 Months of Treatment
In this outcome measure, costs of hospital admissions were based on the number of hospital admissions during the treatment period by considering the reason for hospitalization. If the reason for admission was not related to the recorded event (ischemic, hemorrhagic, or other adverse event), or the participant experienced none of these events, the cost of hospitalization was calculated as the number of days multiplied by the cost per a day of hospitalization (1898.2 CZK per day).
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Percentage of Participants Categorized According to Number of Diagnostic Procedures
In this outcome measure, percentage of participants were categorized according to number of diagnostic procedures.
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Percentage of Participants Categorized According to Type of Ischemic Events During First 6 Months of Treatment
In this outcome measure, percentage of participants were categorized according to type of ischemic events which included cardiac ischemia and stroke/TIA.
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Cost of Ischemic Events During First 6 Months of Treatment
Costs of ischemic events (cardiac ischemia and stroke/TIA) included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the recorded number of ischemic events during the first 6 months of treatment.
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Percentage of Participants Categorized With Major Hemorrhagic Events During First 6 Months of Treatment
In this outcome measure, percentage of participants with major hemorrhagic events which included intracranial bleeding was reported.
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Percentage of Participants Categorized According to Type of Minor Hemorrhagic Events During First 6 Months of Treatment
In this outcome measure, percentage of participants were categorized according to type of minor hemorrhagic events which included epistaxis, gastrointestinal (GI) bleeding, muscle hematomas and intraparenchymal hematoma of the lower lobe.
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Cost of Major Hemorrhagic Events During First 6 Months of Treatment
Costs of major hemorrhagic events (intracranial bleeding) included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the recorded number of major hemorrhagic events during the first 6 months of treatment.
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Cost of Minor Hemorrhagic Events During First 6 Months of Treatment
Costs of minor hemorrhagic events (epistaxis, GI bleeding, muscle hematomas and intraparenchymal hematoma of the lower lobe) included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the recorded number of minor hemorrhagic events during the first 6 months of treatment.
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Number of Participants With Other Adverse Events During First 6 Months of Treatment
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Other adverse events included all events other than ischemic, major and minor hemorrhagic events.
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Cost of Other Adverse Events During First 6 Months of Treatment
Costs of other adverse events included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the number of other adverse events during the treatment.
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Percentage of Participants Who Died (Treatment-Related) During First 6 Months of Treatment
In this outcome measure, percentage of participants who died due to the given treatment were reported.
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)