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

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

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)

Study Overview

• Status: Completed
• Conditions: Venous Thromboembolism (VTE)

• Study Type: Observational
• Enrollment (Actual): 28000

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Flemington, New Jersey, United States, 08822
      • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population will include patients with a hospital or ED discharge International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) or ICD-10 code indicating a primary diagnosis of VTE identified from the Premier Hospital database between 01-Aug-2014 and 31-May-2016. Patients who received apixaban or warfarin with or without LMWH during any time of the hospitalization (from admission to discharge) will be identified. Patients receiving both apixaban and warfarin, or any other direct oral anticoagulant (DOAC), including rivaroxaban, dabigatran, and edoxaban, during the index hospitalizations will be excluded from the study population. Patients will be required to have no evidence of atrial fibrillation (AF) or atrial flutter (AFL) during the index hospitalizations or the baseline periods.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients receiving apixaban; With or without low molecular weight heparin in the inpatient/emergency department (ED) setting
Patients receiving warfarin; With or without low molecular weight heparin in the inpatient/emergency department (ED) setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2016
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: October 21, 2019
• First Submitted That Met QC Criteria: October 24, 2019
• First Posted (Actual): October 28, 2019

Study Record Updates

• Last Update Posted (Actual): October 28, 2019
• Last Update Submitted That Met QC Criteria: October 24, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: CV185-589

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No