The Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-Valvular Atrial Fibrillation Population With DoD Healthcare Coverage

Study Overview
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Brief Summary
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The objective is to assess the safety and effectiveness of new dabigatran and warfarin patients diagnosed with NVAF in the US DoD population.

Detailed Description
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Study Design: Retrospective

Official Title
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The Comparative Safety and Effectiveness of Warfarin and Dabigatran Utilized in the Department of Defense (DoD) Non-Valvular Atrial Fibrillation (NVAF) Patient Population-A Retrospective Database Analysis

Conditions
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Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients must be continuously enrolled in a health plan during the pre-index period; Patients must have at least one inpatient, or one physician office visit, emergency room visit with a diagnosis of AF (ICD-9-CM diagnosis code: 427.31in any position) on the index date or during the pre-index period; Patients must have a prescription for dabigatran or warfarin (this first prescription will be the index date); Patients must be treatment naive from all OAC use prior to first dabigatran or warfarin prescription; Aged 18-89 on the index date; Exclusion criteria: Patients with valvular procedures related to the baseline AF diagnosis will be excluded; Patients with transient causes of AF such as hyperthyroidism, any cardiac surgery, pericarditis, mycoarditis, pulmonary embolism within 3 months prior to their first diagnosis of AF;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dabigatran<br> | |
| Warfarin<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke (Hemorrhagic, Ischemic) | Event rate of stroke (hemorrhagic, ischemic). Variables in the final propensity score model: age, gender index year, baseline CHADS(2) score (Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, Prior Stroke or transient ischemic attack (TIA) or Thromboembolism), baseline CHA(2)DS(2)-VASc score (Congestive heart failure, Hypertension, Age ≥75 years (doubled), Diabetes mellitus, Stroke (doubled), Vascular disease, Age 65-74 years, Sex category), baseline HAS-BLED score (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile International Normalized Ratio, Elderly, Drugs/alcohol concomitantly), baseline use of several medications and presence of several baseline co-morbidities. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | From October 1, 2009 through July 31, 2013 (the study period) | 
| Major Bleeding | Event rate of major bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | From October 1, 2009 through July 31, 2013 (the study period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemic Stroke | Event rate of ischemic stroke. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | From October 1, 2009 through July 31, 2013 (the study period) | 
| Hemorrhagic Stroke | Event rate of hemorrhagic stroke. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | From October 1, 2009 through July 31, 2013 (the study period). | 
| Major Intracranial Bleeding | Event rate of major intracranial bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | From October 1, 2009 through July 31, 2013 (the study period). | 
| Major Extracranial Bleeding | Event rate of major extracranial bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | From October 1, 2009 through July 31, 2013 (the study period). | 
| Major GI Bleeding | Event rate of major gastrointestinal (GI) bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | From October 1, 2009 through July 31, 2013 (the study period). | 
| Major Upper GI Bleeding | Event rate of major upper gastrointestinal (GI) bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | From October 1, 2009 through July 31, 2013 (the study period). | 
| Major Lower GI Bleeding | Event rate of major lower gastrointestinal (GI) bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | From October 1, 2009 through July 31, 2013 (the study period). | 
| Major Urogenital Bleeding | Event rate of major urogenital bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | From October 1, 2009 through July 31, 2013 (the study period). | 
| Major Other Bleeding | Event rate of major other bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | From October 1, 2009 through July 31, 2013 (the study period). | 
| Transient Ischemic Attack | Event rate of transient ischemic attacks. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | From October 1, 2009 through July 31, 2013 (the study period). | 
| Myocardial Infarction | Event rate of myocardial infarction. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | From October 1, 2009 through July 31, 2013 (the study period). | 
| Venous Thromboembolism | Event rate of venous thromboembolism. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | From October 1, 2009 through July 31, 2013 (the study period). | 
| Deep Vein Thrombosis | Event rate of deep vein thrombosis. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | From October 1, 2009 through July 31, 2013 (the study period). | 
| Pulmonary Embolism | Event rate of pulmonary embolism. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | From October 1, 2009 through July 31, 2013 (the study period). | 
| Death | Event rate of death, due to any cause. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period. | From October 1, 2009 through July 31, 2013 (the study period). |