Atrial Fibrillation
Conditions
Brief summary
This study is an opportunity for Boehringer Ingelheim to collaborate with Humana to conduct comparative safety and effectiveness studies of dabigatran and warfarin using real world data from Humana's health plan operations.
Detailed description
Study Design: n/a
Interventions
DRUGObservational
Retrospective Chart Review
Sponsors
Boehringer Ingelheim
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Patient must have at least one inpatient, one physician office visit, or one emergency room visit with a diagnosis of AF on the index date or during the pre-index period. * Patients must be continuously enrolled in a health plan during the pre-index period * Patient must have a prescription for dabigatran or warfarin * Patient must be treatment naive from all oral anticoagulant (OAC) use prior to first OAC prescription * Aged 18-89 years on the index date. The index date is defined as the date of the first OAC prescription
Exclusion criteria
* Diagnosis of hyperthyroidism during the pre-index period, * Having claims for any of the following within 3 months prior to the first diagnosis of AF: cardiac surgery, pericarditis, myocarditis, pulmonary embolism. * Any patients with at least one medical claim for valvular heart disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stroke (Primary Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of stroke (hemorrhagic and ischemic) for dabigatran and warfarin in the primary analysis. Ischemic stroke includes: Occlusion and stenosis of precerebral arteries with cerebral infarction, Occlusion of cerebral arteries with cerebral infarction and Acute, but ill-defined, cerebrovascular disease but excludes above diagnosis if hospitalization lasted less than 48 hours and was accompanied by carotid endarterectomy. Hemorrhagic stroke includes: Subarachnoid hemorrhage (SAH) and Intracerebral hemorrhage (ICH) but excludes previous listed diagnoses if traumatic brain injury or rehabilitation care is present. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization. |
| Stroke (Post-hoc Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of stroke (hemorrhagic and ischemic) for dabigatran and warfarin in the post-hoc analysis. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization. |
| Major Bleeding (Primary Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of major bleeding (hemorrhagic stroke, major intracranial bleeding and major extracranial bleeding) for dabigatran and warfarin in the primary analysis. Major Intracranial Bleeding includes subarachnoid hemorrhage, intracerebral hemorrhage, other and unspecified intracranial hemorrhage, subarachnoid hemorrhage following injury without mention of open intracranial wound, subdural hemorrhage following injury without mention of open intracranial wound, extradural hemorrhage following injury without mention of open intracranial wound, other and unspecified intracranial hemorrhage following injury without mention of open intracranial wound but excludes these codes if major trauma was present. Major extracranial bleeding includes major gastrointestinal (GI) bleeding, major urogenital bleeding and major other bleeding. Either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization were used. |
| Major Bleeding (Post-hoc Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of major bleeding (Inclusive of hemorrhagic stroke, major intracranial bleeding and major extracranial bleeding) for dabigatran and warfarin in the post-hoc analysis. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Intracranial Bleeding (Primary Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of major intracranial bleeding for dabigatran and warfarin in the primary analysis. Major intracranial bleeding includes: Subarachnoid hemorrhage, intracerebral hemorrhage, other and unspecified intracranial hemorrhage, subarachnoid, subdural or extradural hemorrhage following injury without mention of open intracranial wound other and unspecified intracranial hemorrhage following injury without mention of open intracranial wound but excludes these codes if concomitant discharge diagnosis of major trauma was present. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization. |
| Major Intracranial Bleeding (Post-hoc Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of major intracranial bleeding for dabigatran and warfarin in the post-hoc analysis. Major intracranial bleeding includes: Subarachnoid hemorrhage, intracerebral hemorrhage, other and unspecified intracranial hemorrhage, subarachnoid, subdural or extradural hemorrhage following injury without mention of open intracranial wound other and unspecified intracranial hemorrhage following injury without mention of open intracranial wound but excludes these codes if concomitant discharge diagnosis of major trauma was present. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization. |
| Major Extracranial Bleeding (Primary Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of major extracranial bleeding for dabigatran and warfarin in the primary analysis. Major extracranial bleeding includes: major gastrointestinal (GI) bleeding, major urogenital bleeding and major other bleeding. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization. |
| Major Extracranial Bleeding (Post-hoc Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of major extracranial bleeding for dabigatran and warfarin in the post-hoc analysis. Major extracranial bleeding includes: major gastrointestinal (GI) bleeding, major urogenital bleeding and major other bleeding. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization. |
| Major GI Bleeding (Primary Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of major GI bleeding for dabigatran and warfarin in the primary analysis. Major GI bleeding includes major upper GI bleeding and major lower GI bleeding. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization. |
| Major GI Bleeding (Post-hoc Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of major GI bleeding for dabigatran and warfarin in the post-hoc analysis. Major GI bleeding includes major upper GI bleeding and major lower GI bleeding. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization. |
| Major Upper GI Bleeding (Primary Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of major upper GI bleeding for dabigatran and warfarin in the primary analysis. Major upper GI bleeding includes acute gastric ulcer, chronic or unspecified gastric ulcer, acute duodenal ulcer, chronic or unspecified duodenal ulcer, acute, chronic or unspecified peptic ulcer, acute gastrojejunal ulcer, chronic or unspecified gastrojejunal ulcer with hemorrhage with/without obstruction and with hemorrhage and perforation with/without obstruction, hematemesis, endoscopic control of gastric or duodenal bleeding, upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate with control of bleeding, any method. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization. |
| Major Upper GI Bleeding (Post-hoc Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of major upper GI bleeding for dabigatran and warfarin in the post-hoc analysis. Major upper GI bleeding includes acute, chronic or unspecified gastric ulcer, acute duodenal ulcer, chronic or unspecified duodenal ulcer, acute, chronic or unspecified peptic ulcer, acute, chronic or unspecified gastrojejunal ulcer with hemorrhage with/without (w/wo) obstruction and with hemorrhage and perforation w/wo obstruction, hematemesis, endoscopic control of gastric or duodenal bleeding, upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate with control of bleeding, any method. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. This was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization. |
| Major Lower GI Bleeding (Primary Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of major lower GI bleeding for dabigatran and warfarin in the primary analysis. Major lower GI bleeding includes diverticulosis or diverticulitis of small intestine or of colon with hemorrhage, hemorrhage of rectum and anus, angiodysplasia of intestine with hemorrhage, blood in stool and hemorrhage of GI tract (unspecified). Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization. |
| Major Lower GI Bleeding (Post-hoc Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of major lower GI bleeding for dabigatran and warfarin in the post-hoc analysis. Major lower GI bleeding includes diverticulosis or diverticulitis of small intestine or of colon with hemorrhage, hemorrhage of rectum and anus, angiodysplasia of intestine with hemorrhage, blood in stool and hemorrhage of GI tract (unspecified). A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization. |
| Major Urogenital Bleeding (Primary Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of major urogenital bleeding for dabigatran and warfarin in the primary analysis. Major urogenital bleeding includes hematuria and excessive/frequent menstruation and secondary diagnosis indicating acute bleeding (anemia). Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization. |
| Major Urogenital Bleeding (Post-hoc Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of major urogenital bleeding for dabigatran and warfarin in the post-hoc analysis. Major urogenital bleeding includes hematuria and excessive/frequent menstruation and secondary diagnosis indicating acute bleeding (anemia). A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization. |
| Other Major Bleeds (Primary Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of other major bleeds for dabigatran and warfarin in the primary analysis. Other major bleeds includes hemarthrosis, hemopericardium, hemoptysis, epistaxis, hemorrhage (not specified) and acute posthemorrhagic anemia. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization. |
| Ischemic Stroke (Primary Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of ischemic stroke for dabigatran and warfarin in the primary analysis. Ischemic stroke includes: Occlusion and stenosis of precerebral arteries with cerebral infarction, Occlusion of cerebral arteries with cerebral infarction and Acute, but ill-defined, cerebrovascular disease but excludes above diagnosis if hospitalization lasted less than 48 hours and was accompanied by carotid endarterectomy. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization. |
| Transient Ischemic Attack (TIA) (Primary Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of TIA for dabigatran and warfarin in the primary analysis. TIA includes transient cerebral ischemia as the principal (primary) discharge diagnosis. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization. |
| TIA (Post-hoc Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of TIA for dabigatran and warfarin in the post-hoc analysis. TIA includes transient cerebral ischemia as the principal (primary) discharge diagnosis. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization. |
| Myocardial Infarction (MI) (Primary Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of MI for dabigatran and warfarin in the primary analysis. MI includes the acute myocardial infarction. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization. |
| MI (Post-hoc Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of MI for dabigatran and warfarin in the post-hoc analysis. MI includes the acute myocardial infarction. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization. |
| Venous Thromboembolism (Primary Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of venous thromboembolism for dabigatran and warfarin in the primary analysis. Venous thromboembolism includes the deep vein thrombosis and the pulmonary embolism. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization. |
| Venous Thromboembolism (Post-hoc Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of venous thromboembolism for dabigatran and warfarin in the post-hoc analysis. Venous thromboembolism includes the deep vein thrombosis and the pulmonary embolism. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization. |
| Deep Vein Thrombosis (Primary Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of deep vein thrombosis for dabigatran and warfarin in the primary analysis. Deep vein thrombosis includes phlebitis and thrombophlebitis and other venous embolism and thrombosis. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization. |
| Deep Vein Thrombosis (Post-hoc Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of deep vein thrombosis for dabigatran and warfarin in the post-hoc analysis. Deep vein thrombosis includes phlebitis and thrombophlebitis and other venous embolism and thrombosis. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization. |
| Pulmonary Embolism (Primary Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of pulmonary embolism for dabigatran and warfarin in the primary analysis. Pulmonary embolism includes acute pulmonary heart disease. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization. |
| Pulmonary Embolism (Post-hoc Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of pulmonary embolism for dabigatran and warfarin in the post-hoc analysis. Pulmonary embolism includes acute pulmonary heart disease. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization. |
| All-cause Death (Primary Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of death for dabigatran and warfarin in the primary analysis. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization. |
| All-cause Death (Post-hoc Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of death for dabigatran and warfarin in the post-hoc analysis. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization. |
| Other Major Bleeds (Post-hoc Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of other major bleeds for dabigatran and warfarin in the post-hoc analysis. Other major bleeds includes hemarthrosis, hemopericardium, hemoptysis, epistaxis, hemorrhage (not specified) and acute posthemorrhagic anemia. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization. |
| Ischemic Stroke (Post-hoc Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of ischemic stroke for dabigatran and warfarin in the post-hoc analysis. Ischemic stroke includes: Occlusion and stenosis of precerebral arteries with cerebral infarction, Occlusion of cerebral arteries with cerebral infarction and Acute, but ill-defined, cerebrovascular disease but excludes above diagnosis if hospitalization lasted less than 48 hours and was accompanied by carotid endarterectomy. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization. |
| Hemorrhagic Stroke (Primary Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of hemorrhagic stroke for dabigatran and warfarin in the primary analysis. Hemorrhagic stroke includes: subarachnoid hemorrhage, intracerebral hemorrhage but excludes these codes if traumatic brain injury or rehabilitation care as primary code is present. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization. |
| Hemorrhagic Stroke (Post-hoc Analysis) | From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) | This outcome measure describes the incidence of hemorrhagic stroke for dabigatran and warfarin in the post-hoc analysis. Hemorrhagic stroke includes: Subarachnoid hemorrhage and intracerebral hemorrhage but excludes these codes if traumatic brain injury or rehabilitation care as primary code is present. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization. |
Countries
United States
Participant flow
Recruitment details
A non-interventional study based on existing data was conducted. This is a retrospective database analysis to assess the safety and effectiveness of dabigatran compared to warfarin in patients diagnosed with non-valvular atrial fibrillation (NVAF) in the real-world setting using the Humana population.
Pre-assignment details
Participant flow and demographic section is based on Pre-propensity score matching data however to analyze the outcome measures Post-propensity score matching data were used.
Participants by arm
| Arm | Count |
|---|---|
| Dabigatran Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily. | 7,646 |
| Warfarin Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally. | 30,853 |
| Total | 38,499 |
Baseline characteristics
| Characteristic | Dabigatran | Warfarin | Total |
|---|---|---|---|
| Age, Continuous | 73.2 Years STANDARD_DEVIATION 8.6 | 74.8 Years STANDARD_DEVIATION 8.2 | 74.5 Years STANDARD_DEVIATION 8.3 |
| Sex/Gender, Customized Female | 3316 Participants | 13944 Participants | 17260 Participants |
| Sex/Gender, Customized Male | 4330 Participants | 16906 Participants | 21236 Participants |
| Sex/Gender, Customized Unknown | 0 Participants | 3 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Major Bleeding (Post-hoc Analysis)
This outcome measure describes the incidence of major bleeding (Inclusive of hemorrhagic stroke, major intracranial bleeding and major extracranial bleeding) for dabigatran and warfarin in the post-hoc analysis. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | Major Bleeding (Post-hoc Analysis) | 35.6 Events per 1000 patient-years |
| Warfarin | Major Bleeding (Post-hoc Analysis) | 46.9 Events per 1000 patient-years |
Comparison: The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.p-value: 0.0019Chi-squared
Primary
Major Bleeding (Primary Analysis)
This outcome measure describes the incidence of major bleeding (hemorrhagic stroke, major intracranial bleeding and major extracranial bleeding) for dabigatran and warfarin in the primary analysis. Major Intracranial Bleeding includes subarachnoid hemorrhage, intracerebral hemorrhage, other and unspecified intracranial hemorrhage, subarachnoid hemorrhage following injury without mention of open intracranial wound, subdural hemorrhage following injury without mention of open intracranial wound, extradural hemorrhage following injury without mention of open intracranial wound, other and unspecified intracranial hemorrhage following injury without mention of open intracranial wound but excludes these codes if major trauma was present. Major extracranial bleeding includes major gastrointestinal (GI) bleeding, major urogenital bleeding and major other bleeding. Either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization were used.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | Major Bleeding (Primary Analysis) | 61.7 Events per 1000 patient-years |
| Warfarin | Major Bleeding (Primary Analysis) | 76.7 Events per 1000 patient-years |
Comparison: Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.p-value: 0.0011Chi-squared
Primary
Stroke (Post-hoc Analysis)
This outcome measure describes the incidence of stroke (hemorrhagic and ischemic) for dabigatran and warfarin in the post-hoc analysis. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | Stroke (Post-hoc Analysis) | 12.4 Events per 1000 patient-years |
| Warfarin | Stroke (Post-hoc Analysis) | 16.1 Events per 1000 patient-years |
Comparison: The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.p-value: 0.0861Chi-squared
Primary
Stroke (Primary Analysis)
This outcome measure describes the incidence of stroke (hemorrhagic and ischemic) for dabigatran and warfarin in the primary analysis. Ischemic stroke includes: Occlusion and stenosis of precerebral arteries with cerebral infarction, Occlusion of cerebral arteries with cerebral infarction and Acute, but ill-defined, cerebrovascular disease but excludes above diagnosis if hospitalization lasted less than 48 hours and was accompanied by carotid endarterectomy. Hemorrhagic stroke includes: Subarachnoid hemorrhage (SAH) and Intracerebral hemorrhage (ICH) but excludes previous listed diagnoses if traumatic brain injury or rehabilitation care is present. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | Stroke (Primary Analysis) | 21.9 Events per 1000 patient-years |
| Warfarin | Stroke (Primary Analysis) | 29.3 Events per 1000 patient-years |
Comparison: Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.p-value: 0.0111Chi-squared
Secondary
All-cause Death (Post-hoc Analysis)
This outcome measure describes the incidence of death for dabigatran and warfarin in the post-hoc analysis. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | All-cause Death (Post-hoc Analysis) | 36.6 Events per 1000 patient-years |
| Warfarin | All-cause Death (Post-hoc Analysis) | 49.8 Events per 1000 patient-years |
Comparison: The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.p-value: 0.0004Chi-squared
Secondary
All-cause Death (Primary Analysis)
This outcome measure describes the incidence of death for dabigatran and warfarin in the primary analysis. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | All-cause Death (Primary Analysis) | 36.6 Events per 1000 patient-years |
| Warfarin | All-cause Death (Primary Analysis) | 49.8 Events per 1000 patient-years |
Comparison: Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.p-value: 0.0004Chi-squared
Secondary
Deep Vein Thrombosis (Post-hoc Analysis)
This outcome measure describes the incidence of deep vein thrombosis for dabigatran and warfarin in the post-hoc analysis. Deep vein thrombosis includes phlebitis and thrombophlebitis and other venous embolism and thrombosis. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | Deep Vein Thrombosis (Post-hoc Analysis) | 1.0 Events per 1000 patient-years |
| Warfarin | Deep Vein Thrombosis (Post-hoc Analysis) | 1.3 Events per 1000 patient-years |
Comparison: The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.p-value: 0.5331Chi-squared
Secondary
Deep Vein Thrombosis (Primary Analysis)
This outcome measure describes the incidence of deep vein thrombosis for dabigatran and warfarin in the primary analysis. Deep vein thrombosis includes phlebitis and thrombophlebitis and other venous embolism and thrombosis. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | Deep Vein Thrombosis (Primary Analysis) | 9.5 Events per 1000 patient-years |
| Warfarin | Deep Vein Thrombosis (Primary Analysis) | 15.9 Events per 1000 patient-years |
Comparison: Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.p-value: 0.0023Chi-squared
Secondary
Hemorrhagic Stroke (Post-hoc Analysis)
This outcome measure describes the incidence of hemorrhagic stroke for dabigatran and warfarin in the post-hoc analysis. Hemorrhagic stroke includes: Subarachnoid hemorrhage and intracerebral hemorrhage but excludes these codes if traumatic brain injury or rehabilitation care as primary code is present. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | Hemorrhagic Stroke (Post-hoc Analysis) | 1.2 Events per 1000 patient-years |
| Warfarin | Hemorrhagic Stroke (Post-hoc Analysis) | 3.3 Events per 1000 patient-years |
Comparison: The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.p-value: 0.0271Chi-squared
Secondary
Hemorrhagic Stroke (Primary Analysis)
This outcome measure describes the incidence of hemorrhagic stroke for dabigatran and warfarin in the primary analysis. Hemorrhagic stroke includes: subarachnoid hemorrhage, intracerebral hemorrhage but excludes these codes if traumatic brain injury or rehabilitation care as primary code is present. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | Hemorrhagic Stroke (Primary Analysis) | 1.5 Events per 1000 patient-years |
| Warfarin | Hemorrhagic Stroke (Primary Analysis) | 4.4 Events per 1000 patient-years |
Comparison: Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.p-value: 0.0068Chi-squared
Secondary
Ischemic Stroke (Post-hoc Analysis)
This outcome measure describes the incidence of ischemic stroke for dabigatran and warfarin in the post-hoc analysis. Ischemic stroke includes: Occlusion and stenosis of precerebral arteries with cerebral infarction, Occlusion of cerebral arteries with cerebral infarction and Acute, but ill-defined, cerebrovascular disease but excludes above diagnosis if hospitalization lasted less than 48 hours and was accompanied by carotid endarterectomy. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | Ischemic Stroke (Post-hoc Analysis) | 11.2 Events per 1000 patient-years |
| Warfarin | Ischemic Stroke (Post-hoc Analysis) | 12.9 Events per 1000 patient-years |
Comparison: The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.p-value: 0.3502Chi-squared
Secondary
Ischemic Stroke (Primary Analysis)
This outcome measure describes the incidence of ischemic stroke for dabigatran and warfarin in the primary analysis. Ischemic stroke includes: Occlusion and stenosis of precerebral arteries with cerebral infarction, Occlusion of cerebral arteries with cerebral infarction and Acute, but ill-defined, cerebrovascular disease but excludes above diagnosis if hospitalization lasted less than 48 hours and was accompanied by carotid endarterectomy. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | Ischemic Stroke (Primary Analysis) | 21.7 Events per 1000 patient-years |
| Warfarin | Ischemic Stroke (Primary Analysis) | 26.4 Events per 1000 patient-years |
Comparison: Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.p-value: 0.0808Chi-squared
Secondary
Major Extracranial Bleeding (Post-hoc Analysis)
This outcome measure describes the incidence of major extracranial bleeding for dabigatran and warfarin in the post-hoc analysis. Major extracranial bleeding includes: major gastrointestinal (GI) bleeding, major urogenital bleeding and major other bleeding. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | Major Extracranial Bleeding (Post-hoc Analysis) | 31.2 Events per 1000 patient-years |
| Warfarin | Major Extracranial Bleeding (Post-hoc Analysis) | 38.3 Events per 1000 patient-years |
Comparison: The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.p-value: 0.0284Chi-squared
Secondary
Major Extracranial Bleeding (Primary Analysis)
This outcome measure describes the incidence of major extracranial bleeding for dabigatran and warfarin in the primary analysis. Major extracranial bleeding includes: major gastrointestinal (GI) bleeding, major urogenital bleeding and major other bleeding. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | Major Extracranial Bleeding (Primary Analysis) | 54.4 Events per 1000 patient-years |
| Warfarin | Major Extracranial Bleeding (Primary Analysis) | 66.1 Events per 1000 patient-years |
Comparison: Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.p-value: 0.0055Chi-squared
Secondary
Major GI Bleeding (Post-hoc Analysis)
This outcome measure describes the incidence of major GI bleeding for dabigatran and warfarin in the post-hoc analysis. Major GI bleeding includes major upper GI bleeding and major lower GI bleeding. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | Major GI Bleeding (Post-hoc Analysis) | 28.5 Events per 1000 patient-years |
| Warfarin | Major GI Bleeding (Post-hoc Analysis) | 28.7 Events per 1000 patient-years |
Comparison: The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.p-value: 0.8208Chi-squared
Secondary
Major GI Bleeding (Primary Analysis)
This outcome measure describes the incidence of major GI bleeding for dabigatran and warfarin in the primary analysis. Major GI bleeding includes major upper GI bleeding and major lower GI bleeding. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | Major GI Bleeding (Primary Analysis) | 44.4 Events per 1000 patient-years |
| Warfarin | Major GI Bleeding (Primary Analysis) | 44.0 Events per 1000 patient-years |
Comparison: Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.p-value: 0.907Chi-squared
Secondary
Major Intracranial Bleeding (Post-hoc Analysis)
This outcome measure describes the incidence of major intracranial bleeding for dabigatran and warfarin in the post-hoc analysis. Major intracranial bleeding includes: Subarachnoid hemorrhage, intracerebral hemorrhage, other and unspecified intracranial hemorrhage, subarachnoid, subdural or extradural hemorrhage following injury without mention of open intracranial wound other and unspecified intracranial hemorrhage following injury without mention of open intracranial wound but excludes these codes if concomitant discharge diagnosis of major trauma was present. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | Major Intracranial Bleeding (Post-hoc Analysis) | 4.4 Events per 1000 patient-years |
| Warfarin | Major Intracranial Bleeding (Post-hoc Analysis) | 8.6 Events per 1000 patient-years |
Comparison: The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.p-value: 0.0072Chi-squared
Secondary
Major Intracranial Bleeding (Primary Analysis)
This outcome measure describes the incidence of major intracranial bleeding for dabigatran and warfarin in the primary analysis. Major intracranial bleeding includes: Subarachnoid hemorrhage, intracerebral hemorrhage, other and unspecified intracranial hemorrhage, subarachnoid, subdural or extradural hemorrhage following injury without mention of open intracranial wound other and unspecified intracranial hemorrhage following injury without mention of open intracranial wound but excludes these codes if concomitant discharge diagnosis of major trauma was present. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | Major Intracranial Bleeding (Primary Analysis) | 8.0 Events per 1000 patient-years |
| Warfarin | Major Intracranial Bleeding (Primary Analysis) | 11.3 Events per 1000 patient-years |
Comparison: Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.p-value: 0.0749Chi-squared
Secondary
Major Lower GI Bleeding (Post-hoc Analysis)
This outcome measure describes the incidence of major lower GI bleeding for dabigatran and warfarin in the post-hoc analysis. Major lower GI bleeding includes diverticulosis or diverticulitis of small intestine or of colon with hemorrhage, hemorrhage of rectum and anus, angiodysplasia of intestine with hemorrhage, blood in stool and hemorrhage of GI tract (unspecified). A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | Major Lower GI Bleeding (Post-hoc Analysis) | 23.6 Events per 1000 patient-years |
| Warfarin | Major Lower GI Bleeding (Post-hoc Analysis) | 22.7 Events per 1000 patient-years |
Comparison: The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.p-value: 0.8465Chi-squared
Secondary
Major Lower GI Bleeding (Primary Analysis)
This outcome measure describes the incidence of major lower GI bleeding for dabigatran and warfarin in the primary analysis. Major lower GI bleeding includes diverticulosis or diverticulitis of small intestine or of colon with hemorrhage, hemorrhage of rectum and anus, angiodysplasia of intestine with hemorrhage, blood in stool and hemorrhage of GI tract (unspecified). Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | Major Lower GI Bleeding (Primary Analysis) | 43.4 Events per 1000 patient-years |
| Warfarin | Major Lower GI Bleeding (Primary Analysis) | 42.8 Events per 1000 patient-years |
Comparison: Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.p-value: 0.9573Chi-squared
Secondary
Major Upper GI Bleeding (Post-hoc Analysis)
This outcome measure describes the incidence of major upper GI bleeding for dabigatran and warfarin in the post-hoc analysis. Major upper GI bleeding includes acute, chronic or unspecified gastric ulcer, acute duodenal ulcer, chronic or unspecified duodenal ulcer, acute, chronic or unspecified peptic ulcer, acute, chronic or unspecified gastrojejunal ulcer with hemorrhage with/without (w/wo) obstruction and with hemorrhage and perforation w/wo obstruction, hematemesis, endoscopic control of gastric or duodenal bleeding, upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate with control of bleeding, any method. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. This was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | Major Upper GI Bleeding (Post-hoc Analysis) | 5.4 Events per 1000 patient-years |
| Warfarin | Major Upper GI Bleeding (Post-hoc Analysis) | 6.8 Events per 1000 patient-years |
Comparison: The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.p-value: 0.3055Chi-squared
Secondary
Major Upper GI Bleeding (Primary Analysis)
This outcome measure describes the incidence of major upper GI bleeding for dabigatran and warfarin in the primary analysis. Major upper GI bleeding includes acute gastric ulcer, chronic or unspecified gastric ulcer, acute duodenal ulcer, chronic or unspecified duodenal ulcer, acute, chronic or unspecified peptic ulcer, acute gastrojejunal ulcer, chronic or unspecified gastrojejunal ulcer with hemorrhage with/without obstruction and with hemorrhage and perforation with/without obstruction, hematemesis, endoscopic control of gastric or duodenal bleeding, upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate with control of bleeding, any method. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | Major Upper GI Bleeding (Primary Analysis) | 6.6 Events per 1000 patient-years |
| Warfarin | Major Upper GI Bleeding (Primary Analysis) | 9.0 Events per 1000 patient-years |
Comparison: Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.p-value: 0.1534Chi-squared
Secondary
Major Urogenital Bleeding (Post-hoc Analysis)
This outcome measure describes the incidence of major urogenital bleeding for dabigatran and warfarin in the post-hoc analysis. Major urogenital bleeding includes hematuria and excessive/frequent menstruation and secondary diagnosis indicating acute bleeding (anemia). A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | Major Urogenital Bleeding (Post-hoc Analysis) | 0.2 Events per 1000 patient-years |
| Warfarin | Major Urogenital Bleeding (Post-hoc Analysis) | 4.5 Events per 1000 patient-years |
Comparison: The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.p-value: <0.0001Chi-squared
Secondary
Major Urogenital Bleeding (Primary Analysis)
This outcome measure describes the incidence of major urogenital bleeding for dabigatran and warfarin in the primary analysis. Major urogenital bleeding includes hematuria and excessive/frequent menstruation and secondary diagnosis indicating acute bleeding (anemia). Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | Major Urogenital Bleeding (Primary Analysis) | 5.8 Events per 1000 patient-years |
| Warfarin | Major Urogenital Bleeding (Primary Analysis) | 12.1 Events per 1000 patient-years |
Comparison: Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.p-value: 0.0006Chi-squared
Secondary
MI (Post-hoc Analysis)
This outcome measure describes the incidence of MI for dabigatran and warfarin in the post-hoc analysis. MI includes the acute myocardial infarction. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | MI (Post-hoc Analysis) | 8.0 Events per 1000 patient-years |
| Warfarin | MI (Post-hoc Analysis) | 7.5 Events per 1000 patient-years |
Comparison: The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.p-value: 0.8017Chi-squared
Secondary
Myocardial Infarction (MI) (Primary Analysis)
This outcome measure describes the incidence of MI for dabigatran and warfarin in the primary analysis. MI includes the acute myocardial infarction. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | Myocardial Infarction (MI) (Primary Analysis) | 13.6 Events per 1000 patient-years |
| Warfarin | Myocardial Infarction (MI) (Primary Analysis) | 16.1 Events per 1000 patient-years |
Comparison: Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.p-value: 0.2665Chi-squared
Secondary
Other Major Bleeds (Post-hoc Analysis)
This outcome measure describes the incidence of other major bleeds for dabigatran and warfarin in the post-hoc analysis. Other major bleeds includes hemarthrosis, hemopericardium, hemoptysis, epistaxis, hemorrhage (not specified) and acute posthemorrhagic anemia. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | Other Major Bleeds (Post-hoc Analysis) | 2.7 Events per 1000 patient-years |
| Warfarin | Other Major Bleeds (Post-hoc Analysis) | 5.8 Events per 1000 patient-years |
Comparison: The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.p-value: 0.0138Chi-squared
Secondary
Other Major Bleeds (Primary Analysis)
This outcome measure describes the incidence of other major bleeds for dabigatran and warfarin in the primary analysis. Other major bleeds includes hemarthrosis, hemopericardium, hemoptysis, epistaxis, hemorrhage (not specified) and acute posthemorrhagic anemia. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | Other Major Bleeds (Primary Analysis) | 12.7 Events per 1000 patient-years |
| Warfarin | Other Major Bleeds (Primary Analysis) | 18.2 Events per 1000 patient-years |
Comparison: Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.p-value: 0.0185Chi-squared
Secondary
Pulmonary Embolism (Post-hoc Analysis)
This outcome measure describes the incidence of pulmonary embolism for dabigatran and warfarin in the post-hoc analysis. Pulmonary embolism includes acute pulmonary heart disease. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | Pulmonary Embolism (Post-hoc Analysis) | 1.2 Events per 1000 patient-years |
| Warfarin | Pulmonary Embolism (Post-hoc Analysis) | 2.1 Events per 1000 patient-years |
Comparison: The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.p-value: 0.2646Chi-squared
Secondary
Pulmonary Embolism (Primary Analysis)
This outcome measure describes the incidence of pulmonary embolism for dabigatran and warfarin in the primary analysis. Pulmonary embolism includes acute pulmonary heart disease. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | Pulmonary Embolism (Primary Analysis) | 3.4 Events per 1000 patient-years |
| Warfarin | Pulmonary Embolism (Primary Analysis) | 9.1 Events per 1000 patient-years |
Comparison: Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.p-value: 0.0003Chi-squared
Secondary
TIA (Post-hoc Analysis)
This outcome measure describes the incidence of TIA for dabigatran and warfarin in the post-hoc analysis. TIA includes transient cerebral ischemia as the principal (primary) discharge diagnosis. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | TIA (Post-hoc Analysis) | 3.4 Events per 1000 patient-years |
| Warfarin | TIA (Post-hoc Analysis) | 4.4 Events per 1000 patient-years |
Comparison: The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.p-value: 0.4407Chi-squared
Secondary
Transient Ischemic Attack (TIA) (Primary Analysis)
This outcome measure describes the incidence of TIA for dabigatran and warfarin in the primary analysis. TIA includes transient cerebral ischemia as the principal (primary) discharge diagnosis. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | Transient Ischemic Attack (TIA) (Primary Analysis) | 10.7 Events per 1000 patient-years |
| Warfarin | Transient Ischemic Attack (TIA) (Primary Analysis) | 13.0 Events per 1000 patient-years |
Comparison: Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.p-value: 0.261Chi-squared
Secondary
Venous Thromboembolism (Post-hoc Analysis)
This outcome measure describes the incidence of venous thromboembolism for dabigatran and warfarin in the post-hoc analysis. Venous thromboembolism includes the deep vein thrombosis and the pulmonary embolism. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | Venous Thromboembolism (Post-hoc Analysis) | 2.2 Events per 1000 patient-years |
| Warfarin | Venous Thromboembolism (Post-hoc Analysis) | 3.5 Events per 1000 patient-years |
Comparison: The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.p-value: 0.2083Chi-squared
Secondary
Venous Thromboembolism (Primary Analysis)
This outcome measure describes the incidence of venous thromboembolism for dabigatran and warfarin in the primary analysis. Venous thromboembolism includes the deep vein thrombosis and the pulmonary embolism. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
Time frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | Venous Thromboembolism (Primary Analysis) | 12.2 Events per 1000 patient-years |
| Warfarin | Venous Thromboembolism (Primary Analysis) | 23.0 Events per 1000 patient-years |
Comparison: Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.p-value: <0.0001Chi-squared