Atrial Fibrillation
Conditions
Brief summary
The purpose of this study is to assess the safety and effectiveness of newly initiated dabigatran among patients diagnosed with non valvular atrial fibrillation (NVAF) in comparison to newly initiated rivaroxaban users and newly initiated apixaban users
Interventions
DRUGDabigatran vs. Rivaroxaban
observed for 6 years
DRUGDabigatran vs. Apixaban
Observed for 6 years
Sponsors
Health ResearchTx, LLC (HRTX)
inVentiv Health Clinical (iVH)
United States Department of Defense (DOD)
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18+ on index date * Patients must have been prescribed either dabigatran, rivaroxaban, or apixaban identified by pharmacy claim during the study period. The first dispensing date of either study drug will be defined as the index date; * Patients must be treatment naïve from all OAC use prior to the first NOAC prescription, during study period. * Patients must have at least 12 months of continuous eligibility prior to the index date; * Patients must have at least one diagnosis code of atrial fibrillation, defined as International Classification of Diseases (ICD)-9-CM diagnosis of 427.31 or ICD-10-CM diagnosis of I48.0, I48.1, I48.2, I48.91 on the index date or during the pre-index period.
Exclusion criteria
Less than 12 months of continuous eligibility in the pre-index period Any claim for OAC drug (oral use only) in the pre-index period Diagnosis of hyperthyroidism during the pre-index period Having at least one claim for alternative indications; orthopedic procedures, Venous thromboembolism (VTE) (includes deep vein thrombosis (DVT ) & PE)) and the index NOAC prescription at the same time, or, the alternative indication for anticoagulant occurring within 3 months prior to index date in pre-period Having at least one claim with any of the following diagnoses or procedure codes in order to exclude patients with transient causes of Afib (3 months prior to index date in pre-period): * Cardiac surgery * Pericarditis * Myocarditis Having at least one medical claim with any of the following diagnoses or procedures codes in order to exclude patients with valvular Afib (pre-period): * Mitral stenosis * Mitral stenosis with insufficiency * Mitral valve stenosis and aortic valve stenosis * Mitral valve stenosis and aortic valve insufficiency * Diseases of other endocardial structures * Other and unspecified rheumatic heart diseases * Open heart valvuloplasty without replacement * Open and other replacement of unspecified heart valve * Open and other replacement of aortic valve * Open and other replacement of mitral valve * Open and other replacement of pulmonary valve * Open and other replacement of tricuspid valve * Heart valve replaced by transplant * Heart valve replaced by a mechanical device/prosthesis * Atrioventricular valve repair * Aortic valve valvuloplasty * Unlisted procedure, cardiac surgery * Implantation of catheter-delivered prosthetic aortic heart valve; open thoracic approach * Transthoracic cardiac exposure (e.g., sternotomy, thoracotomy, subxiphoid) for catheter-delivered aortic valve replacement; without cardiopulmonary bypass * Transthoracic cardiac exposure (e.g., sternotomy, thoracotomy, subxiphoid) for catheter-delivered aortic valve replacement; with cardiopulmonary bypass * Replacement, aortic valve, with cardiopulmonary bypass; with prosthetic valve other than homograft or stentless valve * Valvuloplasty, mitral valve, with cardiopulmonary bypass * Valvuloplasty, mitral valve, with cardiopulmonary bypass; with prosthetic ring * Valvuloplasty, mitral valve, with cardiopulmonary bypass; radical reconstruction, with or without ring * Replacement, mitral valve, with cardiopulmonary bypass * Implantation of catheter-delivered prosthetic pulmonary valve, endovascular approach * Replacement, pulmonary valve * Valvectomy, tricuspid valve, with cardiopulmonary bypass * Valvuloplasty, tricuspid valve; without ring insertion * Valvuloplasty, tricuspid valve; with ring insertion * Replacement, tricuspid valve, with cardiopulmonary bypass
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stroke Overall (Hemorrhagic, Ischemic, Uncertain) | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years | The event rate of overall stroke (hemorrhagic, ischemic, uncertain) in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Length of Follow-up: The post-index follow-up period began the day following the NOAC index date and ended on whichever of the following occurred earliest: 1. The day of discontinuation of the index NOAC exposure; 2. The day before a switch to an anticoagulant different from the index exposure; 3. The day before a change in dose for the index NOAC; 4. The end of continuous eligibility of a patient in the health plan (disenrollment); 5. The end of the study observation period; or 6. The date of death of the patient. |
| Overall Major Bleeding | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years | The event rate of overall Major bleeding (Hemorrhagic Stroke, Major Intracranial Bleeding and Major Extracranial Bleeding) in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Intracranial Bleeding | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years | The event rate of major intracranial bleeding in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first |
| Major Extracranial Bleeding | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years | The event rate of major extracranial bleeding (Major GI bleeding, Major urogenital bleeding and Major other bleeding) in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first |
| Major GI Bleeding | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years | The event rate of major GI bleeding (Upper GI Bleeding and Lower GI Bleeding) in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first |
| Major Urogenital Bleeding | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years | The event rate of major urogenital bleeding in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first. |
| Ischemic Stroke | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years | The event rate of ischemic stroke in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first |
| Upper GI Bleeding | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years | The event rate of Upper GI Bleeding in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first |
| Lower GI Bleeding | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years | The event rate of Lower GI Bleeding in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first |
| TIA | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years | The event rate of transient ischemic attack (TIA) in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first |
| All-cause Mortality | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years | The event rate of all-cause mortality in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first |
| Major Other Bleeding | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years | The event rate of major other bleeding in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first |
| Hemorrhagic Stroke | Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years | The event rate of Hemorrhagic stroke in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first. |
Countries
United States
Participant flow
Recruitment details
This is a Non-interventional retrospective cohort study based on existing data with propensity score matching (PSM) in Non-valvular Atrial Fibrillation (NVAF) patients with new Non-Vitamin K antagonist oral anticoagulant (NOAC) use.
Pre-assignment details
The study was a US retrospective database of the Department of Defense (DoD) beneficiary population. Data was extracted from July 1, 2010 to June 30, 2016. Thus there was no pre-assignment/screening details.
Participants by arm
| Arm | Count |
|---|---|
| Dabigatran Oral anticoagulant (OAC) treatment naïve NVAF patients with at least one Non-Vitamin K antagonist oral anticoagulant (NOAC) prescription claim for dabigatran . | 12,763 |
| Rivaroxaban OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban . | 17,177 |
| Apixaban OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban . | 12,594 |
| Total | 42,534 |
Baseline characteristics
| Characteristic | Dabigatran | Apixaban | Total | Rivaroxaban |
|---|---|---|---|---|
| Age, Customized Dabigatran vs Apixaban (matched pop) | 70.15 Years STANDARD_DEVIATION 10.23 | 70.20 Years STANDARD_DEVIATION 10.02 | 70.18 Years STANDARD_DEVIATION 10.13 | — |
| Age, Customized Dabigatran vs Rivaroxaban (matched pop) | 70.89 Years STANDARD_DEVIATION 10.03 | — | 70.91 Years STANDARD_DEVIATION 10.05 | 70.92 Years STANDARD_DEVIATION 10.07 |
| Age, Customized Overall | 70.89 Years STANDARD_DEVIATION 10.03 | 72.35 Years STANDARD_DEVIATION 8.93 | 71.48 Years STANDARD_DEVIATION 9.6 | 71.28 Years STANDARD_DEVIATION 9.7 |
| Race/Ethnicity, Customized Dabigatran vs Apixaban (matched pop) Black | 157 Participants | 152 Participants | 309 Participants | — |
| Race/Ethnicity, Customized Dabigatran vs Apixaban (matched pop) Other/Unknown/Missing | 3024 Participants | 3028 Participants | 6052 Participants | — |
| Race/Ethnicity, Customized Dabigatran vs Apixaban (matched pop) White | 1621 Participants | 1622 Participants | 3243 Participants | — |
| Race/Ethnicity, Customized Dabigatran vs Rivaroxaban (matched pop) Black | 302 Participants | — | 599 Participants | 297 Participants |
| Race/Ethnicity, Customized Dabigatran vs Rivaroxaban (matched pop) Other/Unknown/Missing | 8690 Participants | — | 17377 Participants | 8687 Participants |
| Race/Ethnicity, Customized Dabigatran vs Rivaroxaban (matched pop) White | 3771 Participants | — | 7550 Participants | 3779 Participants |
| Race/Ethnicity, Customized Overall Black | 302 Participants | 272 Participants | 932 Participants | 358 Participants |
| Race/Ethnicity, Customized Overall Other/Unknown/Missing | 8690 Participants | 8578 Participants | 28699 Participants | 11431 Participants |
| Race/Ethnicity, Customized Overall White | 3771 Participants | 3744 Participants | 12903 Participants | 5388 Participants |
| Sex/Gender, Customized Dabigatran vs Apixaban (matched pop) Female | 1774 Participants | 1763 Participants | 3537 Participants | — |
| Sex/Gender, Customized Dabigatran vs Apixaban (matched pop) Male | 3028 Participants | 3039 Participants | 6067 Participants | — |
| Sex/Gender, Customized Dabigatran vs Rivaroxaban (matched pop) Female | 4861 Participants | — | 9785 Participants | 4924 Participants |
| Sex/Gender, Customized Dabigatran vs Rivaroxaban (matched pop) Male | 7902 Participants | — | 15741 Participants | 7839 Participants |
| Sex/Gender, Customized Overall Female | 4861 Participants | 5095 Participants | 16744 Participants | 6788 Participants |
| Sex/Gender, Customized Overall Male | 7902 Participants | 7499 Participants | 25790 Participants | 10389 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Overall Major Bleeding
The event rate of overall Major bleeding (Hemorrhagic Stroke, Major Intracranial Bleeding and Major Extracranial Bleeding) in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first.
Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Population: Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran (Dabigatran vs Rivaroxaban) | Overall Major Bleeding | 1.82 Event Rate in 100 person-years |
| Rivaroxaban (Dabigatran vs Rivaroxaban) | Overall Major Bleeding | 2.24 Event Rate in 100 person-years |
| Dabigatran (Dabigatran vs Apixaban) | Overall Major Bleeding | 1.69 Event Rate in 100 person-years |
| Apixaban (Dabigatran vs Apixaban) | Overall Major Bleeding | 1.24 Event Rate in 100 person-years |
Comparison: Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).p-value: 0.018295% CI: [0.696, 0.967]Regression, Cox
Comparison: Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).p-value: 0.070295% CI: [0.974, 1.939]Regression, Cox
Primary
Stroke Overall (Hemorrhagic, Ischemic, Uncertain)
The event rate of overall stroke (hemorrhagic, ischemic, uncertain) in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Length of Follow-up: The post-index follow-up period began the day following the NOAC index date and ended on whichever of the following occurred earliest: 1. The day of discontinuation of the index NOAC exposure; 2. The day before a switch to an anticoagulant different from the index exposure; 3. The day before a change in dose for the index NOAC; 4. The end of continuous eligibility of a patient in the health plan (disenrollment); 5. The end of the study observation period; or 6. The date of death of the patient.
Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Population: Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed. In both cohorts, dabigatran patients were matched 1:1 to comparator patients based on their baseline characteristics using the propensity score matching (PSM).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran (Dabigatran vs Rivaroxaban) | Stroke Overall (Hemorrhagic, Ischemic, Uncertain) | 0.52 Event Rate in 100 person-years |
| Rivaroxaban (Dabigatran vs Rivaroxaban) | Stroke Overall (Hemorrhagic, Ischemic, Uncertain) | 0.69 Event Rate in 100 person-years |
| Dabigatran (Dabigatran vs Apixaban) | Stroke Overall (Hemorrhagic, Ischemic, Uncertain) | 0.46 Event Rate in 100 person-years |
| Apixaban (Dabigatran vs Apixaban) | Stroke Overall (Hemorrhagic, Ischemic, Uncertain) | 0.36 Event Rate in 100 person-years |
Comparison: Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).p-value: 0.084495% CI: [0.566, 1.037]Regression, Cox
Comparison: Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).p-value: 0.489295% CI: [0.659, 2.39]Regression, Cox
Secondary
All-cause Mortality
The event rate of all-cause mortality in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first
Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Population: Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran (Dabigatran vs Rivaroxaban) | All-cause Mortality | 1.54 Event Rate in 100 person-years |
| Rivaroxaban (Dabigatran vs Rivaroxaban) | All-cause Mortality | 1.37 Event Rate in 100 person-years |
| Dabigatran (Dabigatran vs Apixaban) | All-cause Mortality | 1.46 Event Rate in 100 person-years |
| Apixaban (Dabigatran vs Apixaban) | All-cause Mortality | 1.25 Event Rate in 100 person-years |
Comparison: Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).p-value: 0.935995% CI: [0.829, 1.226]Regression, Cox
Comparison: Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).p-value: 0.894795% CI: [0.716, 1.465]Regression, Cox
Secondary
Hemorrhagic Stroke
The event rate of Hemorrhagic stroke in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first.
Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Population: Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran (Dabigatran vs Rivaroxaban) | Hemorrhagic Stroke | 0.03 Event Rate in 100 person-years |
| Rivaroxaban (Dabigatran vs Rivaroxaban) | Hemorrhagic Stroke | 0.16 Event Rate in 100 person-years |
| Dabigatran (Dabigatran vs Apixaban) | Hemorrhagic Stroke | 0.07 Event Rate in 100 person-years |
| Apixaban (Dabigatran vs Apixaban) | Hemorrhagic Stroke | NA Event Rate in 100 person-years |
Comparison: Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).p-value: 0.002395% CI: [0.085, 0.585]Regression, Cox
Secondary
Ischemic Stroke
The event rate of ischemic stroke in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first
Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Population: Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran (Dabigatran vs Rivaroxaban) | Ischemic Stroke | 0.5 Event Rate in 100 person-years |
| Rivaroxaban (Dabigatran vs Rivaroxaban) | Ischemic Stroke | 0.54 Event Rate in 100 person-years |
| Dabigatran (Dabigatran vs Apixaban) | Ischemic Stroke | 0.39 Event Rate in 100 person-years |
| Apixaban (Dabigatran vs Apixaban) | Ischemic Stroke | 0.36 Event Rate in 100 person-years |
Comparison: Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).p-value: 0.630795% CI: [0.667, 1.278]Regression, Cox
Comparison: Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).p-value: 0.877795% CI: [0.54, 2.055]Regression, Cox
Secondary
Lower GI Bleeding
The event rate of Lower GI Bleeding in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first
Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Population: Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran (Dabigatran vs Rivaroxaban) | Lower GI Bleeding | 1.08 Event Rate in 100 person-years |
| Rivaroxaban (Dabigatran vs Rivaroxaban) | Lower GI Bleeding | 1.17 Event Rate in 100 person-years |
| Dabigatran (Dabigatran vs Apixaban) | Lower GI Bleeding | 0.98 Event Rate in 100 person-years |
| Apixaban (Dabigatran vs Apixaban) | Lower GI Bleeding | 0.58 Event Rate in 100 person-years |
Comparison: Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).p-value: 0.472795% CI: [0.741, 1.149]Regression, Cox
Comparison: Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).p-value: 0.027595% CI: [1.062, 2.79]Regression, Cox
Secondary
Major Extracranial Bleeding
The event rate of major extracranial bleeding (Major GI bleeding, Major urogenital bleeding and Major other bleeding) in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first
Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Population: Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran (Dabigatran vs Rivaroxaban) | Major Extracranial Bleeding | 1.55 Event Rate in 100 person-years |
| Rivaroxaban (Dabigatran vs Rivaroxaban) | Major Extracranial Bleeding | 1.83 Event Rate in 100 person-years |
| Dabigatran (Dabigatran vs Apixaban) | Major Extracranial Bleeding | 1.44 Event Rate in 100 person-years |
| Apixaban (Dabigatran vs Apixaban) | Major Extracranial Bleeding | 1.03 Event Rate in 100 person-years |
Comparison: Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).p-value: 0.090195% CI: [0.716, 1.025]Regression, Cox
Comparison: Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).p-value: 0.061695% CI: [0.983, 2.083]Regression, Cox
Secondary
Major GI Bleeding
The event rate of major GI bleeding (Upper GI Bleeding and Lower GI Bleeding) in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first
Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Population: Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran (Dabigatran vs Rivaroxaban) | Major GI Bleeding | 1.45 Event Rate in 100 person-years |
| Rivaroxaban (Dabigatran vs Rivaroxaban) | Major GI Bleeding | 1.66 Event Rate in 100 person-years |
| Dabigatran (Dabigatran vs Apixaban) | Major GI Bleeding | 1.36 Event Rate in 100 person-years |
| Apixaban (Dabigatran vs Apixaban) | Major GI Bleeding | 0.92 Event Rate in 100 person-years |
Comparison: Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).p-value: 0.207395% CI: [0.736, 1.069]Regression, Cox
Comparison: Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).p-value: 0.041795% CI: [1.015, 2.228]Regression, Cox
Secondary
Major Intracranial Bleeding
The event rate of major intracranial bleeding in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first
Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Population: Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran (Dabigatran vs Rivaroxaban) | Major Intracranial Bleeding | 0.27 Event Rate in 100 person-years |
| Rivaroxaban (Dabigatran vs Rivaroxaban) | Major Intracranial Bleeding | 0.41 Event Rate in 100 person-years |
| Dabigatran (Dabigatran vs Apixaban) | Major Intracranial Bleeding | 0.24 Event Rate in 100 person-years |
| Apixaban (Dabigatran vs Apixaban) | Major Intracranial Bleeding | 0.21 Event Rate in 100 person-years |
Comparison: Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).p-value: 0.040695% CI: [0.435, 0.982]Regression, Cox
Comparison: Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).p-value: 0.812495% CI: [0.469, 2.63]Regression, Cox
Secondary
Major Other Bleeding
The event rate of major other bleeding in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first
Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Population: Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran (Dabigatran vs Rivaroxaban) | Major Other Bleeding | 0.13 Event Rate in 100 person-years |
| Rivaroxaban (Dabigatran vs Rivaroxaban) | Major Other Bleeding | 0.18 Event Rate in 100 person-years |
| Dabigatran (Dabigatran vs Apixaban) | Major Other Bleeding | 0.11 Event Rate in 100 person-years |
| Apixaban (Dabigatran vs Apixaban) | Major Other Bleeding | 0.13 Event Rate in 100 person-years |
Comparison: Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).p-value: 0.266395% CI: [0.387, 1.299]Regression, Cox
Comparison: Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).p-value: 0.811295% CI: [0.261, 2.863]Regression, Cox
Secondary
Major Urogenital Bleeding
The event rate of major urogenital bleeding in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first.
Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Population: Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran (Dabigatran vs Rivaroxaban) | Major Urogenital Bleeding | NA Event Rate in 100 person-years |
| Rivaroxaban (Dabigatran vs Rivaroxaban) | Major Urogenital Bleeding | 0.01 Event Rate in 100 person-years |
| Dabigatran (Dabigatran vs Apixaban) | Major Urogenital Bleeding | NA Event Rate in 100 person-years |
| Apixaban (Dabigatran vs Apixaban) | Major Urogenital Bleeding | NA Event Rate in 100 person-years |
Secondary
TIA
The event rate of transient ischemic attack (TIA) in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first
Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Population: Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran (Dabigatran vs Rivaroxaban) | TIA | 0.26 Event Rate in 100 person-years |
| Rivaroxaban (Dabigatran vs Rivaroxaban) | TIA | 0.20 Event Rate in 100 person-years |
| Dabigatran (Dabigatran vs Apixaban) | TIA | 0.28 Event Rate in 100 person-years |
| Apixaban (Dabigatran vs Apixaban) | TIA | 0.17 Event Rate in 100 person-years |
Comparison: Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).p-value: 0.230995% CI: [0.828, 2.189]Regression, Cox
Comparison: Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).p-value: 0.333395% CI: [0.635, 3.821]Regression, Cox
Secondary
Upper GI Bleeding
The event rate of Upper GI Bleeding in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first
Time frame: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Population: Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran (Dabigatran vs Rivaroxaban) | Upper GI Bleeding | 0.41 Event Rate in 100 person-years |
| Rivaroxaban (Dabigatran vs Rivaroxaban) | Upper GI Bleeding | 0.55 Event Rate in 100 person-years |
| Dabigatran (Dabigatran vs Apixaban) | Upper GI Bleeding | 0.37 Event Rate in 100 person-years |
| Apixaban (Dabigatran vs Apixaban) | Upper GI Bleeding | 0.34 Event Rate in 100 person-years |
Comparison: Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).p-value: 0.122795% CI: [0.546, 1.075]Regression, Cox
Comparison: Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).p-value: 0.711595% CI: [0.573, 2.26]Regression, Cox