An observational study in Atrial Fibrillation, sponsored by Boehringer Ingelheim. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-02.
Sponsored by Boehringer Ingelheim · Observational
This cohort study is the sequential expansion of the comparative effectiveness study of oral anticoagulants and plans to identify initiators of oral anticoagulants using electronic claims data from a commercial insurance database to quantify associations between anticoagulant choice (warfarin and dabigatran) and the occurrence of selected outcomes in patients with non-valvular atrial fibrillation at risk for stroke.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 221,228 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients 18 years of age and older with non-valvular AF initiating oral anticoagulation therapy
Exclusion criteria:
Stroke (Hemorrhagic, Ischemic, or Stroke of Uncertain Classification)
The rate of overall stroke (hemorrhagic, ischemic or stroke of uncertain classification ) in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: As primary International Classification of Diseases, Ninth Revision (ICD-9) discharge diagnosis (Dx): 431.x Intracerebral hemorrhage (ICH), 433.x1 Occlusion and stenosis of precerebral arteries with cerebral infarction, 434.x1 Occlusion and stenosis of cerebral arteries with cerebral infarction, 436.x Acute, but ill-defined cerebrovascular events.
Time frame: From October 2010 to September 2015 (the study period)
Major Bleeding
The rate of major bleeding (Major intracranial bleeding and major extracranial bleed ) in patients who are matched on propensity score and calendar quarter of initiation. 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. For outcome definitions please refer the descriptions section of outcome 8 (major intracranial bleeding) and outcome 9 (major extracranial bleeding).
Time frame: From October 2010 to September 2015 (the study period)
Stroke or Systemic Embolism
The rate of stroke (hemorrhagic, ischemic or stroke of uncertain classification ) or systemic embolism in patients matched on propensity scores and calendar quarter of initiation. 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. For outcome definitions please refer the descriptions section of outcome 4 (Systemic embolism), outcome 5 (Ischemic stroke), outcome 6 (Hemorrhagic stroke) and outcome 7 (Stroke uncertain classification).
Time frame: From October 2010 to September 2015 (the study period)
Systemic Embolism
The rate of systemic embolism in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: ICD-9 Diagnoses: 444.x Arterial embolism.
Time frame: From October 2010 to September 2015 (the study period)
Ischemic Stroke
The rate of ischemic stroke in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: As primary ICD-9 discharge diagnosis (Dx): 433.x1 Occlusion and stenosis of precerebral arteries with cerebral infarction, ICD-9 Dx 434.x1 Occlusion and stenosis of cerebral arteries with cerebral infarction
Time frame: From October 2010 to September 2015 (the study period)
Hemorrhagic Stroke
The rate of hemorrhagic in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: As primary ICD-9 discharge diagnosis (Dx): 431.x Intracerebral hemorrhage (ICH)
Time frame: From October 2010 to September 2015 (the study period)
Stroke Uncertain Classification
The rate of stroke uncertain classification in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: As primary ICD-9 discharge diagnosis (Dx): ICD-9 Dx code 436.x (acute, but ill-defined cerebrovascular disease).
Time frame: From October 2010 to September 2015 (the study period)
Major Intracranial Bleeding
The rate of major intracranial bleeding in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: ICD-9 diagnosis: 430.x Subarachnoid hemorrhage (SAH), 431.x Intracerebral hemorrhage (ICH), 432.x other and unspecified intracranial hemorrhage including 432.1x - subdural hemorrhage
Time frame: From October 2010 to September 2015 (the study period)
Major Extra-cranial Bleeding
The rate of major extracranial bleeding (Major upper GI bleed, major lower and unspecified GI bleed, major urogenital bleed, major other bleed) in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as 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. For outcome definitions please refer the descriptions section of outcome 11 (Major upper gastrointestinal bleeding), outcome 12 (Major lower gastrointestinal bleeding), outcome 13 (Major urogenital bleeding) and outcome 14 (Other major bleeding).
Time frame: From October 2010 to September 2015 (the study period)
Major Gastrointestinal (GI) Bleeding
The rate of major gastrointestinal (GI) bleeding (Major upper GI bleeding, major lower/unspecified GI bleeding) in patients who are matched on propensity score and calendar quarter of initiation. 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. For outcome definitions please refer the descriptions section of outcome 11 (Major upper gastrointestinal bleeding) and outcome 12 (Major lower gastrointestinal bleeding).
Time frame: From October 2010 to September 2015 (the study period)
Major Upper Gastrointestinal Bleeding
The rate of Major upper gastrointestinal bleeding in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: ICD-9 diagnoses: 531.0x, 531.2x, 531.4x, 531.6x, 532.0x, 532.2x, 532.4x, 532.6x, 533.0x, 533.2x, 533.4x, 533.6x, 534.0x, 534.2x, 534.4x, 534.6x, 578.0 OR ICD-9 procedure code 44.43 (endoscopic control of gastric or duodenal bleeding) OR Current Procedural Terminology (CPT) code 43255 (upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate with control of bleeding, any method).
Time frame: From October 2010 to September 2015 (the study period)
Major Lower Gastrointestinal Bleeding
The rate of lower gastrointestinal bleeding in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: Lower GI/unspecified GI site bleeds :Diverticulosis of small intestine with hemorrhage: 562.02, Diverticulitis of small intestine with hemorrhage: 562.03, Diverticulosis of colon with hemorrhage: 562.12, Diverticulitis of colon with hemorrhage: 562.13, Hemorrhage of rectum and anus: 569.3x, Angiodysplasia of intestine with hemorrhage: 569.85, Blood in stool: 578.1x, Hemorrhage of GI tract, unspecified: 578.9
Time frame: From October 2010 to September 2015 (the study period)
Major Urogenital Bleeding
The rate of major urogenital bleeding in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: ICD-9 diagnoses: Hematuria: ICD-9 Dx: 599.7, Excessive/frequent menstruation: ICD-9 Dx 626.2x and secondary diagnosis indicating acute bleeding: anemia (280.0, 285.1, 285.9). Across databases, only one event for dabigatran versus no event among warfarin initiators observed. Across database, four events for rivaroxaban versus no event among warfarin initiators observed. Across database, no events for apixaban and warfarin observed. Therefore HR estimate is not possible.
Time frame: From October 2010 to September 2015 (the study period)
Other Major Bleeding
The rate of Other major bleeding in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: Other major bleeds: Hemathrosis: 719.1x, Hemopericardium: 423.0x, Hemoptysis: 786.3x, Epistaxis: 784.7x, Hemorrhage not specified 459.0x, Acute posthemorrhagic anemia 285.1x
Time frame: From October 2010 to September 2015 (the study period)
Transient Ischemic Attack (TIA)
The rate of Transient Ischemic Attack (TIA) in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: ICD-9 Dx code 435.xx (transient cerebral ischemia) as the principal (primary) discharge diagnosis
Time frame: From October 2010 to September 2015 (the study period)
Myocardial Infarction (MI)
The rate of Myocardial infarction (MI) in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: ICD-9 Dx 410.X (acute myocardial infarction) excluding 410.x2 (subsequent episode of care), as the principal (primary) or the next (secondary) diagnosis AND a length of stay (LOS) between 3-180 days, or death if LOS is \< 3 days
Time frame: From October 2010 to September 2015 (the study period)
Venous Thromboembolism (VTE)
The rate of Venous Thromboembolism (VTE) in patients who are matched on propensity score and calendar quarter of initiation. 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. For outcome definitions please refer the descriptions section of outcome 18 (Deep vein thrombosis (DVT)) and outcome 19 (Pulmonary Embolism (PE)).
Time frame: From October 2010 to September 2015 (the study period)
Deep Vein Thrombosis (DVT)
The rate of DVT in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: Validated algorithm: ICD-9 451.1x, ICD-9 451.2x,ICD-9 451.81, ICD-9 451.9x, ICD-9 453.1x, ICD-9 453.2x, ICD-9 453.8x, ICD-9 453.9x ; Not in the validated algorithm but will be included following Mini-Sentinel recommendation for VTE outcome: ICD-9 453.40 (Venous embolism and thrombosis of unspecified deep vessels of lower extremity (includes DVT), ICD-9 453.41 (Venous embolism and thrombosis of deep vessels of proximal lower extremity (includes femoral, iliac, popliteal, thigh, and upper leg), ICD-9 453.42 (Venous embolism and thrombosis of deep vessels of distal lower extremity (includes calf, lower leg, peroneal, and tibia), ICD-9 453.0 (Hepatic vein thrombosis)
Time frame: From October 2010 to September 2015 (the study period)
Pulmonary Embolism (PE)
The rate of Pulmonary Embolism (PE) in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: ICD-9 415.1x (pulmonary embolism and infarction)
Time frame: From October 2010 to September 2015 (the study period)
Data for the patients included in this cohort study arose from two de-identified research databases, US MarketScan and Optum Research Database
| Milestone | Optum Clinformatics - Dabigatran | Optum Clinformatics - Warfarin | Optum Clinformatics - Rivaroxaban | Optum Clinformatics - Apixaban | MarketScan - Dabigatran | MarketScan - Warfarin | MarketScan - Rivaroxaban | MarketScan - Apixaban |
|---|---|---|---|---|---|---|---|---|
| Started | 7668 | 26149 | 14852 | 9112 | 27456 | 76055 | 40207 | 19729 |
| Completed | 7668 | 26149 | 14852 | 9112 | 27456 | 76055 | 40207 | 19729 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
The rate of overall stroke (hemorrhagic, ischemic or stroke of uncertain classification ) in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: As primary International Classification of Diseases, Ninth Revision (ICD-9) discharge diagnosis (Dx): 431.x Intracerebral hemorrhage (ICH), 433.x1 Occlusion and stenosis of precerebral arteries with cerebral infarction, 434.x1 Occlusion and stenosis of cerebral arteries with cerebral infarction, 436.x Acute, but ill-defined cerebrovascular events.
| Incidence rate per 100 person-years | Optum Clinformatics - Dabigatran vs. Warfarin (Dabigatran) | Optum Clinformatics - Dabigatran vs. Warfarin (Warfarin) | MarketScan - Dabigatran vs. Warfarin (Dabigatran) | MarketScan - Dabigatran vs. Warfarin (Warfarin) | Optum Clinformatics - Rivaroxaban vs. Warfarin (Rivaroxaban) | Optum Clinformatics - Rivaroxaban vs. Warfarin (Warfarin) | MarketScan - Rivaroxaban vs. Warfarin (Rivaroxaban) | MarketScan - Rivaroxaban vs. Warfarin (Warfarin) | Optum Clinformatics - Apixaban vs. Warfarin (Apixaban) | Optum Clinformatics - Apixaban vs. Warfarin (Warfarin) | MarketScan - Apixaban vs. Warfarin (Apixaban) | MarketScan - Apixaban vs. Warfarin (Warfarin) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stroke (Hemorrhagic, Ischemic, or Stroke of Uncertain Classification) | 0.90 (0.60 to 1.30) | 1.01 (0.66 to 1.50) | 0.64 (0.51 to 0.80) | 0.99 (0.80 to 1.20) | 0.80 (0.56 to 1.11) | 1.02 (0.72 to 1.39) | 0.78 (0.64 to 0.94) | 1.09 (0.90 to 1.31) | 1.08 (0.74 to 1.53) | 1.26 (0.86 to 1.80) | 0.62 (0.44 to 0.84) | 1.16 (0.87 to 1.51) |
The rate of major bleeding (Major intracranial bleeding and major extracranial bleed ) in patients who are matched on propensity score and calendar quarter of initiation. 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. For outcome definitions please refer the descriptions section of outcome 8 (major intracranial bleeding) and outcome 9 (major extracranial bleeding).
| Incidence rate per 100 person-years | Optum Clinformatics - Dabigatran vs. Warfarin (Dabigatran) | Optum Clinformatics - Dabigatran vs. Warfarin (Warfarin) | MarketScan - Dabigatran vs. Warfarin (Dabigatran) | MarketScan - Dabigatran vs. Warfarin (Warfarin) | Optum Clinformatics - Rivaroxaban vs. Warfarin (Rivaroxaban) | Optum Clinformatics - Rivaroxaban vs. Warfarin (Warfarin) | MarketScan - Rivaroxaban vs. Warfarin (Rivaroxaban) | MarketScan - Rivaroxaban vs. Warfarin (Warfarin) | Optum Clinformatics - Apixaban vs. Warfarin (Apixaban) | Optum Clinformatics - Apixaban vs. Warfarin (Warfarin) | MarketScan - Apixaban vs. Warfarin (Apixaban) | MarketScan - Apixaban vs. Warfarin (Warfarin) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Major Bleeding | 2.43 (1.91 to 3.05) | 5.23 (4.35 to 6.24) | 4.36 (4.00 to 4.74) | 6.06 (5.58 to 6.56) | 6.2 (5.5 to 7.0) | 6.3 (5.5 to 7.2) | 6.9 (6.5 to 7.4) | 7.5 (7.0 to 8.0) | 3.33 (2.69 to 4.07) | 6.83 (5.80 to 7.99) | 4.25 (3.74 to 4.80) | 7.96 (7.15 to 8.83) |
The rate of stroke (hemorrhagic, ischemic or stroke of uncertain classification ) or systemic embolism in patients matched on propensity scores and calendar quarter of initiation. 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. For outcome definitions please refer the descriptions section of outcome 4 (Systemic embolism), outcome 5 (Ischemic stroke), outcome 6 (Hemorrhagic stroke) and outcome 7 (Stroke uncertain classification).
| Incidence rate per 100 person-years | Dabigatran vs. Warfarin (Dabigatran) | Dabigatran vs. Warfarin (Warfarin) | Rivaroxaban vs. Warfarin (Rivaroxaban) | Rivaroxaban vs. Warfarin (Warfarin) | Apixaban vs. Warfarin (Apixaban) | Apixaban vs. Warfarin (Warfarin) |
|---|---|---|---|---|---|---|
| Stroke or Systemic Embolism | 0.92 (0.77 to 1.08) | 1.13 (0.95 to 1.33) | 1.00 (0.85 to 1.15) | 1.29 (1.11 to 1.50) | 0.81 (0.63 to 1.02) | 1.36 (1.10 to 1.66) |
The rate of systemic embolism in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: ICD-9 Diagnoses: 444.x Arterial embolism.
| Incidence rate per 100 person-years | Dabigatran vs. Warfarin (Dabigatran) | Dabigatran vs. Warfarin (Warfarin) | Rivaroxaban vs. Warfarin (Rivaroxaban) | Rivaroxaban vs. Warfarin (Warfarin) | Apixaban vs. Warfarin (Apixaban) | Apixaban vs. Warfarin (Warfarin) |
|---|---|---|---|---|---|---|
| Systemic Embolism | 0.23 (0.17 to 0.32) | 0.14 (0.08 to 0.22) | 0.21 (0.15 to 0.29) | 0.22 (0.15 to 0.32) | 0.05 (0.02 to 0.11) | 0.17 (0.09 to 0.29) |
The rate of ischemic stroke in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: As primary ICD-9 discharge diagnosis (Dx): 433.x1 Occlusion and stenosis of precerebral arteries with cerebral infarction, ICD-9 Dx 434.x1 Occlusion and stenosis of cerebral arteries with cerebral infarction
| Incidence rate per 100 person-years | Dabigatran vs. Warfarin (Dabigatran) | Dabigatran vs. Warfarin (Warfarin) | Rivaroxaban vs. Warfarin (Rivaroxaban) | Rivaroxaban vs. Warfarin (Warfarin) | Apixaban vs. Warfarin (Apixaban) | Apixaban vs. Warfarin (Warfarin) |
|---|---|---|---|---|---|---|
| Ischemic Stroke | 0.63 (0.51 to 0.76) | 0.80 (0.65 to 0.97) | 0.63 (0.52 to 0.75) | 0.90 (0.75 to 1.07) | 0.61 (0.46 to 0.79) | 1.03 (0.80 to 1.29) |
The rate of hemorrhagic in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: As primary ICD-9 discharge diagnosis (Dx): 431.x Intracerebral hemorrhage (ICH)
| Incidence rate per 100 person-years | Dabigatran vs. Warfarin (Dabigatran) | Dabigatran vs. Warfarin (Warfarin) | Rivaroxaban vs. Warfarin (Rivaroxaban) | Rivaroxaban vs. Warfarin (Warfarin) | Apixaban vs. Warfarin (Apixaban) | Apixaban vs. Warfarin (Warfarin) |
|---|---|---|---|---|---|---|
| Hemorrhagic Stroke | 0.07 (0.03 to 0.12) | 0.19 (0.12 to 0.28) | 0.18 (0.12 to 0.25) | 0.18 (0.12 to 0.26) | 0.15 (0.09 to 0.25) | 0.18 (0.10 to 0.31) |
The rate of stroke uncertain classification in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: As primary ICD-9 discharge diagnosis (Dx): ICD-9 Dx code 436.x (acute, but ill-defined cerebrovascular disease).
| Incidence rate per 100 person-years | Dabigatran vs. Warfarin (Dabigatran) | Dabigatran vs. Warfarin (Warfarin) | Rivaroxaban vs. Warfarin (Rivaroxaban) | Rivaroxaban vs. Warfarin (Warfarin) | Apixaban vs. Warfarin (Apixaban) | Apixaban vs. Warfarin (Warfarin) |
|---|---|---|---|---|---|---|
| Stroke Uncertain Classification | 0.00 (0.00 to 0.02) | 0.00 (0.00 to 0.02) | 0.00 (0.00 to 0.01) | 0.00 (0.00 to 0.02) | 0.00 (0.00 to 0.03) | 0.00 (0.00 to 0.04) |
The rate of major intracranial bleeding in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: ICD-9 diagnosis: 430.x Subarachnoid hemorrhage (SAH), 431.x Intracerebral hemorrhage (ICH), 432.x other and unspecified intracranial hemorrhage including 432.1x - subdural hemorrhage
| Incidence rate per 100 person-years | Dabigatran vs. Warfarin (Dabigatran) | Dabigatran vs. Warfarin (Warfarin) | Rivaroxaban vs. Warfarin (Rivaroxaban) | Rivaroxaban vs. Warfarin (Warfarin) | Apixaban vs. Warfarin (Apixaban) | Apixaban vs. Warfarin (Warfarin) |
|---|---|---|---|---|---|---|
| Major Intracranial Bleeding | 0.21 (0.15 to 0.30) | 0.58 (0.46 to 0.73) | 0.44 (0.35 to 0.55) | 0.66 (0.53 to 0.81) | 0.45 (0.32 to 0.60) | 0.69 (0.51 to 0.92) |
The rate of major extracranial bleeding (Major upper GI bleed, major lower and unspecified GI bleed, major urogenital bleed, major other bleed) in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as 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. For outcome definitions please refer the descriptions section of outcome 11 (Major upper gastrointestinal bleeding), outcome 12 (Major lower gastrointestinal bleeding), outcome 13 (Major urogenital bleeding) and outcome 14 (Other major bleeding).
| Incidence rate per 100 person-years | Dabigatran vs. Warfarin (Dabigatran) | Dabigatran vs. Warfarin (Warfarin) | Rivaroxaban vs. Warfarin (Rivaroxaban) | Rivaroxaban vs. Warfarin (Warfarin) | Apixaban vs. Warfarin (Apixaban) | Apixaban vs. Warfarin (Warfarin) |
|---|---|---|---|---|---|---|
| Major Extra-cranial Bleeding | 3.78 (3.48 to 4.10) | 5.37 (4.96 to 5.79) | 6.31 (5.94 to 6.69) | 6.54 (6.11 to 6.99) | 3.51 (3.13 to 3.92) | 6.92 (6.31 to 7.58) |
The rate of major gastrointestinal (GI) bleeding (Major upper GI bleeding, major lower/unspecified GI bleeding) in patients who are matched on propensity score and calendar quarter of initiation. 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. For outcome definitions please refer the descriptions section of outcome 11 (Major upper gastrointestinal bleeding) and outcome 12 (Major lower gastrointestinal bleeding).
| Incidence rate per 100 person-years | Dabigatran vs. Warfarin (Dabigatran) | Dabigatran vs. Warfarin (Warfarin) | Rivaroxaban vs. Warfarin (Rivaroxaban) | Rivaroxaban vs. Warfarin (Warfarin) | Apixaban vs. Warfarin (Apixaban) | Apixaban vs. Warfarin (Warfarin) |
|---|---|---|---|---|---|---|
| Major Gastrointestinal (GI) Bleeding | 2.39 (2.15 to 2.65) | 2.82 (2.53 to 3.13) | 3.82 (3.53 to 4.12) | 3.43 (3.13 to 3.76) | 1.99 (1.70 to 2.30) | 3.59 (3.16 to 4.07) |
The rate of Major upper gastrointestinal bleeding in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: ICD-9 diagnoses: 531.0x, 531.2x, 531.4x, 531.6x, 532.0x, 532.2x, 532.4x, 532.6x, 533.0x, 533.2x, 533.4x, 533.6x, 534.0x, 534.2x, 534.4x, 534.6x, 578.0 OR ICD-9 procedure code 44.43 (endoscopic control of gastric or duodenal bleeding) OR Current Procedural Terminology (CPT) code 43255 (upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate with control of bleeding, any method).
| Incidence rate per 100 person-years | Dabigatran vs. Warfarin (Dabigatran) | Dabigatran vs. Warfarin (Warfarin) | Rivaroxaban vs. Warfarin (Rivaroxaban) | Rivaroxaban vs. Warfarin (Warfarin) | Apixaban vs. Warfarin (Apixaban) | Apixaban vs. Warfarin (Warfarin) |
|---|---|---|---|---|---|---|
| Major Upper Gastrointestinal Bleeding | 0.51 (0.41 to 0.64) | 0.90 (0.74 to 1.08) | 0.99 (0.85 to 1.15) | 0.88 (0.73 to 1.05) | 0.64 (0.49 to 0.83) | 0.89 (0.68 to 1.14) |
The rate of lower gastrointestinal bleeding in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: Lower GI/unspecified GI site bleeds :Diverticulosis of small intestine with hemorrhage: 562.02, Diverticulitis of small intestine with hemorrhage: 562.03, Diverticulosis of colon with hemorrhage: 562.12, Diverticulitis of colon with hemorrhage: 562.13, Hemorrhage of rectum and anus: 569.3x, Angiodysplasia of intestine with hemorrhage: 569.85, Blood in stool: 578.1x, Hemorrhage of GI tract, unspecified: 578.9
| Incidence rate per 100 person-years | Dabigatran vs. Warfarin (Dabigatran) | Dabigatran vs. Warfarin (Warfarin) | Rivaroxaban vs. Warfarin (Rivaroxaban) | Rivaroxaban vs. Warfarin (Warfarin) | Apixaban vs. Warfarin (Apixaban) | Apixaban vs. Warfarin (Warfarin) |
|---|---|---|---|---|---|---|
| Major Lower Gastrointestinal Bleeding | 2.18 (1.96 to 2.43) | 2.48 (2.21 to 2.77) | 3.40 (3.13 to 3.69) | 3.09 (2.80 to 3.39) | 1.61 (1.36 to 1.90) | 3.17 (2.76 to 3.62) |
The rate of major urogenital bleeding in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: ICD-9 diagnoses: Hematuria: ICD-9 Dx: 599.7, Excessive/frequent menstruation: ICD-9 Dx 626.2x and secondary diagnosis indicating acute bleeding: anemia (280.0, 285.1, 285.9). Across databases, only one event for dabigatran versus no event among warfarin initiators observed. Across database, four events for rivaroxaban versus no event among warfarin initiators observed. Across database, no events for apixaban and warfarin observed. Therefore HR estimate is not possible.
| Incidence rate per 100 person-years | Dabigatran vs. Warfarin (Dabigatran) | Dabigatran vs. Warfarin (Warfarin) | Rivaroxaban vs. Warfarin (Rivaroxaban) | Rivaroxaban vs. Warfarin (Warfarin) | Apixaban vs. Warfarin (Apixaban) | Apixaban vs. Warfarin (Warfarin) |
|---|---|---|---|---|---|---|
| Major Urogenital Bleeding | 0.01 (0.00 to 0.03) | 0.00 (0.00 to 0.02) | 0.02 (0.01 to 0.06) | 0.00 (0.00 to 0.02) | 0.00 (0.00 to 0.03) | 0.00 (0.00 to 0.04) |
The rate of Other major bleeding in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: Other major bleeds: Hemathrosis: 719.1x, Hemopericardium: 423.0x, Hemoptysis: 786.3x, Epistaxis: 784.7x, Hemorrhage not specified 459.0x, Acute posthemorrhagic anemia 285.1x
| Incidence rate per 100 person-years | Dabigatran vs. Warfarin (Dabigatran) | Dabigatran vs. Warfarin (Warfarin) | Rivaroxaban vs. Warfarin (Rivaroxaban) | Rivaroxaban vs. Warfarin (Warfarin) | Apixaban vs. Warfarin (Apixaban) | Apixaban vs. Warfarin (Warfarin) |
|---|---|---|---|---|---|---|
| Other Major Bleeding | 2.32 (2.08 to 2.57) | 3.65 (3.33 to 4.01) | 4.33 (4.02 to 4.65) | 4.59 (4.24 to 4.97) | 2.54 (2.22 to 2.90) | 4.86 (4.35 to 5.41) |
The rate of Transient Ischemic Attack (TIA) in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: ICD-9 Dx code 435.xx (transient cerebral ischemia) as the principal (primary) discharge diagnosis
| Incidence rate per 100 person-years | Dabigatran vs. Warfarin (Dabigatran) | Dabigatran vs. Warfarin (Warfarin) | Rivaroxaban vs. Warfarin (Rivaroxaban) | Rivaroxaban vs. Warfarin (Warfarin) | Apixaban vs. Warfarin (Apixaban) | Apixaban vs. Warfarin (Warfarin) |
|---|---|---|---|---|---|---|
| Transient Ischemic Attack (TIA) | 0.21 (0.15 to 0.30) | 0.43 (0.32 to 0.56) | 0.26 (0.19 to 0.34) | 0.31 (0.23 to 0.42) | 0.22 (0.14 to 0.34) | 0.32 (0.20 to 0.48) |
The rate of Myocardial infarction (MI) in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: ICD-9 Dx 410.X (acute myocardial infarction) excluding 410.x2 (subsequent episode of care), as the principal (primary) or the next (secondary) diagnosis AND a length of stay (LOS) between 3-180 days, or death if LOS is \< 3 days
| Incidence rate per 100 person-years | Dabigatran vs. Warfarin (Dabigatran) | Dabigatran vs. Warfarin (Warfarin) | Rivaroxaban vs. Warfarin (Rivaroxaban) | Rivaroxaban vs. Warfarin (Warfarin) | Apixaban vs. Warfarin (Apixaban) | Apixaban vs. Warfarin (Warfarin) |
|---|---|---|---|---|---|---|
| Myocardial Infarction (MI) | 0.48 (0.38 to 0.60) | 0.60 (0.48 to 0.75) | 0.53 (0.43 to 0.64) | 0.65 (0.52 to 0.80) | 0.57 (0.43 to 0.75) | 0.74 (0.55 to 0.97) |
The rate of Venous Thromboembolism (VTE) in patients who are matched on propensity score and calendar quarter of initiation. 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. For outcome definitions please refer the descriptions section of outcome 18 (Deep vein thrombosis (DVT)) and outcome 19 (Pulmonary Embolism (PE)).
| Incidence rate per 100 person-years | Dabigatran vs. Warfarin (Dabigatran) | Dabigatran vs. Warfarin (Warfarin) | Rivaroxaban vs. Warfarin (Rivaroxaban) | Rivaroxaban vs. Warfarin (Warfarin) | Apixaban vs. Warfarin (Apixaban) | Apixaban vs. Warfarin (Warfarin) |
|---|---|---|---|---|---|---|
| Venous Thromboembolism (VTE) | 0.67 (0.55 to 0.81) | 1.14 (0.96 to 1.34) | 1.20 (1.04 to 1.37) | 1.65 (1.45 to 1.88) | 0.57 (0.43 to 0.75) | 1.21 (0.96 to 1.50) |
The rate of DVT in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: Validated algorithm: ICD-9 451.1x, ICD-9 451.2x,ICD-9 451.81, ICD-9 451.9x, ICD-9 453.1x, ICD-9 453.2x, ICD-9 453.8x, ICD-9 453.9x ; Not in the validated algorithm but will be included following Mini-Sentinel recommendation for VTE outcome: ICD-9 453.40 (Venous embolism and thrombosis of unspecified deep vessels of lower extremity (includes DVT), ICD-9 453.41 (Venous embolism and thrombosis of deep vessels of proximal lower extremity (includes femoral, iliac, popliteal, thigh, and upper leg), ICD-9 453.42 (Venous embolism and thrombosis of deep vessels of distal lower extremity (includes calf, lower leg, peroneal, and tibia), ICD-9 453.0 (Hepatic vein thrombosis)
| Incidence rate per 100 person-years | Dabigatran vs. Warfarin (Dabigatran) | Dabigatran vs. Warfarin (Warfarin) | Rivaroxaban vs. Warfarin (Rivaroxaban) | Rivaroxaban vs. Warfarin (Warfarin) | Apixaban vs. Warfarin (Apixaban) | Apixaban vs. Warfarin (Warfarin) |
|---|---|---|---|---|---|---|
| Deep Vein Thrombosis (DVT) | 0.46 (0.36 to 0.58) | 0.78 (0.64 to 0.95) | 0.78 (0.66 to 0.93) | 1.09 (0.93 to 1.28) | 0.41 (0.29 to 0.56) | 0.75 (0.57 to 0.99) |
The rate of Pulmonary Embolism (PE) in patients who are matched on propensity score and calendar quarter of initiation. 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. The outcome definition includes following: ICD-9 415.1x (pulmonary embolism and infarction)
| Incidence rate per 100 person-years | Dabigatran vs. Warfarin (Dabigatran) | Dabigatran vs. Warfarin (Warfarin) | Rivaroxaban vs. Warfarin (Rivaroxaban) | Rivaroxaban vs. Warfarin (Warfarin) | Apixaban vs. Warfarin (Apixaban) | Apixaban vs. Warfarin (Warfarin) |
|---|---|---|---|---|---|---|
| Pulmonary Embolism (PE) | 0.29 (0.21 to 0.38) | 0.46 (0.35 to 0.59) | 0.54 (0.44 to 0.66) | 0.81 (0.67 to 0.97) | 0.22 (0.14 to 0.34) | 0.62 (0.45 to 0.83) |
Collected over Individual safety reporting was not applicable for this study. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Optum Clinformatics - Dabigatran | — | — | — |
| Optum Clinformatics - Warfarin | — | — | — |
| Optum Clinformatics - Rivaroxaban | — | — | — |
| Optum Clinformatics - Apixaban | — | — | — |
| MarketScan - Dabigatran | — | — | — |
| MarketScan - Warfarin | — | — | — |
| MarketScan - Rivaroxaban | — | — | — |
| MarketScan - Apixaban | — | — | — |
Patients with non- valvular atrial fibrillation (NVAF) and new initiators of dabigatran, warfarin, rivaroxaban or apixaban during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation
| Age, Continuous(Years) | Optum Clinformatics - Dabigatran | Optum Clinformatics - Warfarin | Optum Clinformatics - Rivaroxaban | Optum Clinformatics - Apixaban | MarketScan - Dabigatran | MarketScan - Warfarin | MarketScan - Rivaroxaban | MarketScan - Apixaban | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 63.9 ± 11.3 | 69.9 ± 11.8 | 68.0 ± 11.9 | 71.9 ± 11.2 | 67.1 ± 12.1 | 71.0 ± 12.1 | 67.6 ± 12.2 | 69.4 ± 12.3 | 69.2 ± 12.2 |
| Sex: Female, Male(Participants) | Optum Clinformatics - Dabigatran | Optum Clinformatics - Warfarin | Optum Clinformatics - Rivaroxaban | Optum Clinformatics - Apixaban | MarketScan - Dabigatran | MarketScan - Warfarin | MarketScan - Rivaroxaban | MarketScan - Apixaban | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | 2315 | 10143 | 5483 | 3911 | 9774 | 29693 | 15014 | 7747 | 84080 |
| Male | 5353 | 16006 | 9369 | 5201 | 17682 | 46362 | 25193 | 11982 | 137148 |
| Race and Ethnicity Not Collected(Participants) | Optum Clinformatics - Dabigatran | Optum Clinformatics - Warfarin | Optum Clinformatics - Rivaroxaban | Optum Clinformatics - Apixaban | MarketScan - Dabigatran | MarketScan - Warfarin | MarketScan - Rivaroxaban | MarketScan - Apixaban | Total |
|---|---|---|---|---|---|---|---|---|---|
| Count of participants | — | — | — | — | — | — | — | — | 0 |
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Boehringer Ingelheim