A Study of Hospital Healthcare Use and Cost in Patients in the Hospital With a Venous Thromboembolism (VTE) Treated With Apixaban or Warfarin in the US

Study Overview
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Brief Summary
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A study involving real-world database analysis to evaluate the hospital healthcare utilization and costs, and all-cause, major bleeding-, clinically relevant bleeding-, any bleeding-, and venous thromboembolism (VTE)-related hospital readmissions among hospitalized VTE patients treated with apixaban or warfarin, with or without low molecular weight heparin (LMWH)

Official Title
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Evaluation of Hospital Healthcare Utilization and Costs Among Hospitalized Venous Thromboembolism (VTE) Patients Treated With Apixaban or Warfarin in the United States

Conditions
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Venous Thromboembolism (VTE)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a primary diagnosis of VTE identified by ICD-9-CM or ICD-10 codes from the Premier Hospital database between 01-Aug-2014 and 31-May-2016 Age 18 years or older as of index hospitalization with VTE diagnosis Patients will be required to have received apixaban or warfarin with or without LMWH (index drugs) during the index hospitalizations Exclusion Criteria: Received both apixaban and warfarin during the index hospitalization. This exclusion criterion will allow to cleanly group patients into the apixaban and warfarin usage cohorts. Received any other Direct oral anticoagulants (DOAC) including rivaroxaban, dabigatran, and edoxaban during the index hospitalization Have any primary or secondary diagnosis code for Atrial fibrillation/Atrial flutter (AF/AFL), or pregnancy, or records of inferior vena cava filter (IVCF) usage during the index hospitalizations or the baseline periods. Patients transferred from other facilities Other protocol-defined inclusion/exclusion criteria could apply

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 |
| --- | --- |
| Patients receiving apixaban<br>With or without low molecular weight heparin in the inpatient/emergency department (ED) setting | |
| Patients receiving warfarin<br>With or without low molecular weight heparin in the inpatient/emergency department (ED) setting | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Length of stay (LOS) |  | During the index hospitalization (Up to 30 days) | 
| Hospital cost |  | During the index hospitalization (Up to 30 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with major bleeding (MB)-related hospital readmissions |  | During 1 month after the index hospitalization | 
| Proportion of patients with clinically relevant bleeding (CRB)-related hospital readmissions |  | During 1 month after the index hospitalization | 
| Proportion of patients with any bleeding-related hospital readmissions |  | During 1 month after the index hospitalization | 
| Proportion of patients with VTE-related hospital readmissions |  | During 1 month after the index hospitalization | 
| Proportion of patients with combined VTE- or MB-related hospital readmissions |  | During 1 month after the index hospitalization | 
| Proportion of patients with all-cause hospital readmissions |  | During 1 month after the index hospitalization | 
| Hospital Length of stay (LOS) for major bleeding-related hospital readmissions |  | During 1 month following the VTE hospitalization | 
| Hospital costs of readmissions for major bleeding-related hospital readmissions |  | During 1 month following the VTE hospitalization | 
| Hospital charges of readmissions for major bleeding-related hospital readmissions |  | During 1 month following the VTE hospitalization] | 
| Mean number of hospital readmissions for major bleeding-related hospital readmissions |  | During 1 month following the VTE hospitalization | 
| Hospital LOS for clinically relevant bleeding-related hospital readmissions |  | During 1 month following the VTE hospitalization | 
| Hospital costs of readmissions for clinically relevant bleeding-related hospital readmissions |  | During 1 month following the VTE hospitalization | 
| Hospital charges of readmissions for clinically relevant bleeding-related hospital readmissions |  | During 1 month following the VTE hospitalization | 
| Mean number of hospital readmissions for clinically relevant bleeding-related hospital readmissions |  | During 1 month following the VTE hospitalization | 
| Hospital LOS for any bleeding-related hospital readmissions |  | During 1 month following the VTE hospitalization | 
| Hospital costs of readmissions for any bleeding-related hospital readmissions |  | During 1 month following the VTE hospitalization | 
| Hospital charges of readmissions for any bleeding-related hospital readmissions |  | During 1 month following the VTE hospitalization | 
| Mean number of hospital readmissions for any bleeding-related hospital readmissions |  | During 1 month following the VTE hospitalization | 
| Hospital LOS for VTE-related hospital readmissions |  | During 1 month following the VTE hospitalization | 
| Hospital costs of readmissions for VTE-related hospital readmissions |  | During 1 month following the VTE hospitalization | 
| Hospital charges of readmissions for VTE-related hospital readmissions |  | During 1 month following the VTE hospitalization | 
| Mean number of hospital readmissions for VTE-related hospital readmissions |  | During 1 month following the VTE hospitalization | 
| Hospital LOS for combined VTE- or MB-related hospital readmissions |  | During 1 month following the VTE hospitalization | 
| Hospital costs of readmissions for combined VTE- or MB-related hospital readmissions |  | During 1 month following the VTE hospitalization | 
| Hospital charges of readmissions for combined VTE- or MB-related hospital readmissions |  | During 1 month following the VTE hospitalization | 
| Mean number of hospital readmissions for combined VTE- or MB-related hospital readmissions |  | During 1 month following the VTE hospitalization | 
| Hospital LOS for all-cause hospital readmissions |  | During 1 month following the VTE hospitalization | 
| Hospital costs of readmissions for all-cause hospital readmissions |  | During 1 month following the VTE hospitalization | 
| Hospital charges of readmissions for all-cause hospital readmissions |  | During 1 month following the VTE hospitalization | 
| Mean number of hospital readmissions for all-cause hospital readmissions |  | During 1 month following the VTE hospitalization |