Atrial Fibrillation
Conditions
Brief summary
To describe the direct costs related to warfarin/apixaban treatment
Detailed description
To describe the direct costs related to warfarin/apixaban treatment during the first 6 months of the secondary stroke prevention in NVAF patients.
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of non-valvular atrial fibrillation (NVAF); * New initiation of anticoagulation therapy (apixaban or warfarin) due to the ischemic event (stroke/TIA) meaning patients previously not anticoagulated due to diagnosis of NVAF; * Indication to anticoagulation therapy as a secondary stroke prevention within 7 to 30 days after the stroke/TIA event; * Apixaban arm: genetically determined higher sensitivity to warfarin; * Patients whose status allowed oral treatment with apixaban/warfarin; * Age ≥ 18; * Access to patient´s records of the first 6 months of the warfarin/apixaban treatment.
Exclusion criteria
* Diagnosis of valvular disease; * Treatment with other anticoagulants in previous 6 months due to other the NVAF indication; * Treatment or prophylaxis of deep vein thrombosis or pulmonary embolism; * Contraindications according SmPC of Eliquis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CHA2-DS2-VASc Score at Baseline | Baseline (from retrospective data retrieved in the study) | 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. |
| HAS-BLED Score at Baseline | Baseline (from retrospective data retrieved in the study) | 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. |
| CHA2-DS2-VASc Score at Month 6 | Month 6 (from retrospective data retrieved in the study) | 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. |
| HAS-BLED Score at Month 6 | Month 6 (from retrospective data retrieved in the study) | 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. |
| Percentage of Participants Categorized According to Number of Outpatient Visits During First 6 Months of Treatment | Up to first 6 months of treatment (from retrospective data retrieved in the study) | In this outcome measure, percentage of participants were categorized according to number of outpatient visits from 0 to 5. |
| Cost of Outpatient Visits During First 6 Months of Treatment | Up to first 6 months of treatment (from retrospective data retrieved in the study) | 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. |
| Percentage of Participants Categorized According to Number of International Normalized Ratios (INR) Measurements During First 6 Months of Treatment | Up to first 6 months of treatment (from retrospective data retrieved in the study) | 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. |
| Cost of INR Measurements During First 6 Months of Treatment | Up to first 6 months of treatment (from retrospective data retrieved in the study) | 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. |
| Dosage of Warfarin and Apixaban at the Initiation of the Treatment | Baseline (from retrospective data retrieved in the study) | In this outcome measure, dosage of apixaban and warfarin used at the initiation of treatment was reported. |
| Dosage of Warfarin and Apixaban During First 6 Months of Treatment | Up to first 6 months of treatment (from retrospective data retrieved in the study) | In this outcome measure, dosage of apixaban and warfarin used during first 6 months of treatment was reported. |
| Cost of Medication During First 6 Months of Treatment | Up to first 6 months of treatment (from retrospective data retrieved in the study) | 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. |
| Percentage of Participants Categorized According to Number of Hospital Admissions | Up to first 6 months of treatment (from retrospective data retrieved in the study) | In this outcome measure, percentage of participants were categorized according to number of hospital admissions from 0 to 3 were reported. |
| Cost of Hospital Admissions During First 6 Months of Treatment | Up to first 6 months of treatment (from retrospective data retrieved in the study) | 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). |
| Percentage of Participants Categorized According to Number of Diagnostic Procedures | Up to first 6 months of treatment (from retrospective data retrieved in the study) | In this outcome measure, percentage of participants were categorized according to number of diagnostic procedures. |
| Percentage of Participants Categorized According to Type of Ischemic Events During First 6 Months of Treatment | Up to first 6 months of treatment (from retrospective data retrieved in the study) | In this outcome measure, percentage of participants were categorized according to type of ischemic events which included cardiac ischemia and stroke/TIA. |
| Cost of Ischemic Events During First 6 Months of Treatment | Up to first 6 months of treatment (from retrospective data retrieved in the study) | 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. |
| Percentage of Participants Categorized With Major Hemorrhagic Events During First 6 Months of Treatment | Up to first 6 months of treatment (from retrospective data retrieved in the study) | In this outcome measure, percentage of participants with major hemorrhagic events which included intracranial bleeding was reported. |
| Percentage of Participants Categorized According to Type of Minor Hemorrhagic Events During First 6 Months of Treatment | Up to first 6 months of treatment (from retrospective data retrieved in the study) | 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. |
| Cost of Major Hemorrhagic Events During First 6 Months of Treatment | Up to first 6 months of treatment (from retrospective data retrieved in the study) | 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. |
| Cost of Minor Hemorrhagic Events During First 6 Months of Treatment | Up to first 6 months of treatment (from retrospective data retrieved in the study) | 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. |
| Number of Participants With Other Adverse Events During First 6 Months of Treatment | Up to first 6 months of treatment (from retrospective data retrieved in the study) | 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. |
| Cost of Other Adverse Events During First 6 Months of Treatment | Up to first 6 months of treatment (from retrospective data retrieved in the study) | 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. |
| Percentage of Participants Who Died (Treatment-Related) During First 6 Months of Treatment | Up to first 6 months of treatment (from retrospective data retrieved in the study) | In this outcome measure, percentage of participants who died due to the given treatment were reported. |
Countries
Czechia
Participant flow
Recruitment details
Data from eligible participants with non-valvular atrial fibrillation (NVAF) who started treatment with warfarin or apixaban for the prevention of a secondary stroke or transient ischemic attack (TIA) between 2009 to 2019 were observed in this study. Participants' records were retrieved and observed only for first 6 months of the warfarin/apixaban treatment. Collected data from all the participants were observed approximately for 10 months in this observational study.
Participants by arm
| Arm | Count |
|---|---|
| Apixaban Participants with NVAF who received apixaban as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study. | 40 |
| Warfarin Participants with NVAF who received warfarin as per clinical practice in real world for the prevention of a secondary stroke or TIA were observed during this retrospective study. | 63 |
| Total | 103 |
Baseline characteristics
| Characteristic | Apixaban | Warfarin | Total |
|---|---|---|---|
| Age, Continuous | 78.1 Years STANDARD_DEVIATION 12.1 | 79.5 Years STANDARD_DEVIATION 9.3 | 79.0 Years STANDARD_DEVIATION 10.4 |
| Body-Mass Index (BMI) | 26.9 Kilogram per meter square (kg/m^2) STANDARD_DEVIATION 4.8 | 28.7 Kilogram per meter square (kg/m^2) STANDARD_DEVIATION 5.4 | 28.0 Kilogram per meter square (kg/m^2) STANDARD_DEVIATION 5.2 |
| Duration from index event to the initiation of non-vitamin K antagonist anticoagulant therapy (NOAC) | 11.8 Days STANDARD_DEVIATION 12.7 | 10.0 Days STANDARD_DEVIATION 6.2 | 10.7 Days STANDARD_DEVIATION 9.2 |
| Number of Participants With Anticoagulant Treatment Before the Initiation of NOAC Therapy Aspirin | 19 Participants | 35 Participants | 54 Participants |
| Number of Participants With Anticoagulant Treatment Before the Initiation of NOAC Therapy Clexane | 18 Participants | 26 Participants | 44 Participants |
| Number of Participants With Anticoagulant Treatment Before the Initiation of NOAC Therapy Clopidogrel | 11 Participants | 8 Participants | 19 Participants |
| Number of Participants With Anticoagulant Treatment Before the Initiation of NOAC Therapy Fraxiparine | 14 Participants | 19 Participants | 33 Participants |
| Number of Participants With Anticoagulant Treatment Before the Initiation of NOAC Therapy Low molecular weight heparin (LMWH) - preventive dose | 18 Participants | 33 Participants | 51 Participants |
| Number of Participants With Anticoagulant Treatment Before the Initiation of NOAC Therapy Thrombolytics | 15 Participants | 9 Participants | 24 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 17 Participants | 34 Participants | 51 Participants |
| Sex: Female, Male Male | 23 Participants | 29 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 1 / 67 |
| other Total, other adverse events | 4 / 42 | 0 / 67 |
| serious Total, serious adverse events | 2 / 42 | 10 / 67 |
Outcome results
Primary
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)
Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apixaban | CHA2-DS2-VASc Score at Baseline | 4.6 Units on a scale | Standard Deviation 1.5 |
| Warfarin | CHA2-DS2-VASc Score at Baseline | 4.3 Units on a scale | Standard Deviation 1.7 |
Primary
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)
Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apixaban | CHA2-DS2-VASc Score at Month 6 | 5.0 Units on a scale | Standard Deviation 1.4 |
| Warfarin | CHA2-DS2-VASc Score at Month 6 | 4.9 Units on a scale | Standard Deviation 1.4 |
Primary
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)
Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apixaban | Cost of Hospital Admissions During First 6 Months of Treatment | 2777.5 Czech koruna | Standard Deviation 13820.1 |
| Warfarin | Cost of Hospital Admissions During First 6 Months of Treatment | 12326.8 Czech koruna | Standard Deviation 43596.2 |
Primary
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)
Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apixaban | Cost of INR Measurements During First 6 Months of Treatment | 5.3 Czech koruna | Standard Deviation 33.7 |
| Warfarin | Cost of INR Measurements During First 6 Months of Treatment | 4003.0 Czech koruna | Standard Deviation 1230.2 |
Primary
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)
Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apixaban | Cost of Ischemic Events During First 6 Months of Treatment | 684.8 Czech koruna | Standard Deviation 4331.2 |
| Warfarin | Cost of Ischemic Events During First 6 Months of Treatment | 5386.6 Czech koruna | Standard Deviation 16735.9 |
Primary
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)
Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apixaban | Cost of Major Hemorrhagic Events During First 6 Months of Treatment | 2092.7 Czech koruna | Standard Deviation 13235.4 |
| Warfarin | Cost of Major Hemorrhagic Events During First 6 Months of Treatment | 2657.4 Czech koruna | Standard Deviation 14793.8 |
Primary
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)
Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apixaban | Cost of Medication During First 6 Months of Treatment | 8551.0 Czech koruna | Standard Deviation 2932.5 |
| Warfarin | Cost of Medication During First 6 Months of Treatment | 1263.5 Czech koruna | Standard Deviation 0 |
Primary
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)
Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apixaban | Cost of Minor Hemorrhagic Events During First 6 Months of Treatment | 1285.1 Czech koruna | Standard Deviation 5697.5 |
| Warfarin | Cost of Minor Hemorrhagic Events During First 6 Months of Treatment | 1666.7 Czech koruna | Standard Deviation 10157.1 |
Primary
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)
Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apixaban | Cost of Other Adverse Events During First 6 Months of Treatment | 2063.9 Czech koruna | Standard Deviation 9628.8 |
| Warfarin | Cost of Other Adverse Events During First 6 Months of Treatment | 1328.7 Czech koruna | Standard Deviation 10546.2 |
Primary
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)
Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apixaban | Cost of Outpatient Visits During First 6 Months of Treatment | 258.8 Czech koruna | Standard Deviation 320.4 |
| Warfarin | Cost of Outpatient Visits During First 6 Months of Treatment | 414.3 Czech koruna | Standard Deviation 525.7 |
Primary
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)
Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apixaban | Dosage of Warfarin and Apixaban at the Initiation of the Treatment | 7.5 Milligrams per day | Standard Deviation 2.5 |
| Warfarin | Dosage of Warfarin and Apixaban at the Initiation of the Treatment | 5.9 Milligrams per day | Standard Deviation 3.2 |
Primary
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)
Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apixaban | Dosage of Warfarin and Apixaban During First 6 Months of Treatment | 7.4 Milligrams per day | Standard Deviation 2.5 |
| Warfarin | Dosage of Warfarin and Apixaban During First 6 Months of Treatment | 4.6 Milligrams per day | Standard Deviation 1.8 |
Primary
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)
Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apixaban | HAS-BLED Score at Baseline | 2.7 Units on a scale | Standard Deviation 1.2 |
| Warfarin | HAS-BLED Score at Baseline | 2.5 Units on a scale | Standard Deviation 1.1 |
Primary
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.
Time frame: Month 6 (from retrospective data retrieved in the study)
Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apixaban | HAS-BLED Score at Month 6 | 3.1 Units on a scale | Standard Deviation 1.1 |
| Warfarin | HAS-BLED Score at Month 6 | 2.8 Units on a scale | Standard Deviation 1.3 |
Primary
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)
Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Apixaban | Number of Participants With Other Adverse Events During First 6 Months of Treatment | 2 Participants |
| Warfarin | Number of Participants With Other Adverse Events During First 6 Months of Treatment | 1 Participants |
Primary
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)
Population: Data collected by trial sites for diagnostic procedures were incorrect, hence data was not evaluated and analyzed for this outcome measure.
Primary
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)
Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Apixaban | Percentage of Participants Categorized According to Number of Hospital Admissions | 1 | 2.5 Percentage of participants |
| Apixaban | Percentage of Participants Categorized According to Number of Hospital Admissions | 0 | 95.0 Percentage of participants |
| Apixaban | Percentage of Participants Categorized According to Number of Hospital Admissions | 2 | 0.0 Percentage of participants |
| Apixaban | Percentage of Participants Categorized According to Number of Hospital Admissions | 3 | 2.5 Percentage of participants |
| Warfarin | Percentage of Participants Categorized According to Number of Hospital Admissions | 3 | 0.0 Percentage of participants |
| Warfarin | Percentage of Participants Categorized According to Number of Hospital Admissions | 1 | 14.3 Percentage of participants |
| Warfarin | Percentage of Participants Categorized According to Number of Hospital Admissions | 2 | 4.8 Percentage of participants |
| Warfarin | Percentage of Participants Categorized According to Number of Hospital Admissions | 0 | 81.0 Percentage of participants |
Primary
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)
Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Apixaban | Percentage of Participants Categorized According to Number of International Normalized Ratios (INR) Measurements During First 6 Months of Treatment | 1 to 9 | 2.5 Percentage of participants |
| Apixaban | Percentage of Participants Categorized According to Number of International Normalized Ratios (INR) Measurements During First 6 Months of Treatment | 0 | 97.5 Percentage of participants |
| Apixaban | Percentage of Participants Categorized According to Number of International Normalized Ratios (INR) Measurements During First 6 Months of Treatment | >=20 | 0.0 Percentage of participants |
| Apixaban | Percentage of Participants Categorized According to Number of International Normalized Ratios (INR) Measurements During First 6 Months of Treatment | 10 to 19 | 0.0 Percentage of participants |
| Warfarin | Percentage of Participants Categorized According to Number of International Normalized Ratios (INR) Measurements During First 6 Months of Treatment | >=20 | 49.2 Percentage of participants |
| Warfarin | Percentage of Participants Categorized According to Number of International Normalized Ratios (INR) Measurements During First 6 Months of Treatment | 0 | 0.0 Percentage of participants |
| Warfarin | Percentage of Participants Categorized According to Number of International Normalized Ratios (INR) Measurements During First 6 Months of Treatment | 10 to 19 | 46.0 Percentage of participants |
| Warfarin | Percentage of Participants Categorized According to Number of International Normalized Ratios (INR) Measurements During First 6 Months of Treatment | 1 to 9 | 4.8 Percentage of participants |
Primary
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)
Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Apixaban | Percentage of Participants Categorized According to Number of Outpatient Visits During First 6 Months of Treatment | 3 visits | 0.0 Percentage of participants |
| Apixaban | Percentage of Participants Categorized According to Number of Outpatient Visits During First 6 Months of Treatment | 0 visit | 55.0 Percentage of participants |
| Apixaban | Percentage of Participants Categorized According to Number of Outpatient Visits During First 6 Months of Treatment | 1 visit | 32.5 Percentage of participants |
| Apixaban | Percentage of Participants Categorized According to Number of Outpatient Visits During First 6 Months of Treatment | 2 visits | 12.5 Percentage of participants |
| Apixaban | Percentage of Participants Categorized According to Number of Outpatient Visits During First 6 Months of Treatment | 4 visits | 0.0 Percentage of participants |
| Apixaban | Percentage of Participants Categorized According to Number of Outpatient Visits During First 6 Months of Treatment | 5 visits | 0.0 Percentage of participants |
| Warfarin | Percentage of Participants Categorized According to Number of Outpatient Visits During First 6 Months of Treatment | 4 visits | 4.8 Percentage of participants |
| Warfarin | Percentage of Participants Categorized According to Number of Outpatient Visits During First 6 Months of Treatment | 3 visits | 3.2 Percentage of participants |
| Warfarin | Percentage of Participants Categorized According to Number of Outpatient Visits During First 6 Months of Treatment | 2 visits | 9.5 Percentage of participants |
| Warfarin | Percentage of Participants Categorized According to Number of Outpatient Visits During First 6 Months of Treatment | 0 visit | 44.4 Percentage of participants |
| Warfarin | Percentage of Participants Categorized According to Number of Outpatient Visits During First 6 Months of Treatment | 5 visits | 1.6 Percentage of participants |
| Warfarin | Percentage of Participants Categorized According to Number of Outpatient Visits During First 6 Months of Treatment | 1 visit | 36.5 Percentage of participants |
Primary
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)
Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Apixaban | Percentage of Participants Categorized According to Type of Ischemic Events During First 6 Months of Treatment | Cardiac ischemia | 2.5 Percentage of participants |
| Apixaban | Percentage of Participants Categorized According to Type of Ischemic Events During First 6 Months of Treatment | Stroke/TIA | 0.0 Percentage of participants |
| Warfarin | Percentage of Participants Categorized According to Type of Ischemic Events During First 6 Months of Treatment | Cardiac ischemia | 0.0 Percentage of participants |
| Warfarin | Percentage of Participants Categorized According to Type of Ischemic Events During First 6 Months of Treatment | Stroke/TIA | 9.5 Percentage of participants |
Primary
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)
Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Apixaban | Percentage of Participants Categorized According to Type of Minor Hemorrhagic Events During First 6 Months of Treatment | Epistaxis | 2.5 Percentage of participants |
| Apixaban | Percentage of Participants Categorized According to Type of Minor Hemorrhagic Events During First 6 Months of Treatment | GI bleeding | 0.0 Percentage of participants |
| Apixaban | Percentage of Participants Categorized According to Type of Minor Hemorrhagic Events During First 6 Months of Treatment | Muscle hematomas | 2.5 Percentage of participants |
| Apixaban | Percentage of Participants Categorized According to Type of Minor Hemorrhagic Events During First 6 Months of Treatment | Other- Intraparenchymal hematoma of the lower lobe | 0.0 Percentage of participants |
| Warfarin | Percentage of Participants Categorized According to Type of Minor Hemorrhagic Events During First 6 Months of Treatment | Other- Intraparenchymal hematoma of the lower lobe | 1.6 Percentage of participants |
| Warfarin | Percentage of Participants Categorized According to Type of Minor Hemorrhagic Events During First 6 Months of Treatment | Epistaxis | 0.0 Percentage of participants |
| Warfarin | Percentage of Participants Categorized According to Type of Minor Hemorrhagic Events During First 6 Months of Treatment | Muscle hematomas | 0.0 Percentage of participants |
| Warfarin | Percentage of Participants Categorized According to Type of Minor Hemorrhagic Events During First 6 Months of Treatment | GI bleeding | 1.6 Percentage of participants |
Primary
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)
Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Apixaban | Percentage of Participants Categorized With Major Hemorrhagic Events During First 6 Months of Treatment | 2.5 Percentage of participants |
| Warfarin | Percentage of Participants Categorized With Major Hemorrhagic Events During First 6 Months of Treatment | 3.2 Percentage of participants |
Primary
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)
Population: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Apixaban | Percentage of Participants Who Died (Treatment-Related) During First 6 Months of Treatment | 0.0 Percentage of participants |
| Warfarin | Percentage of Participants Who Died (Treatment-Related) During First 6 Months of Treatment | 1.6 Percentage of participants |