Evaluation of Hospital Readmissions Among Hospitalized Non-valvular Atrial Fibrillation (NVAF) Patients in the US

Study Overview
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Brief Summary
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The overall objective of this proposal is to execute a real-world database analysis to evaluate hospital readmissions among hospitalized nonvalvular atrial fibrillation (NVAF) patients in the U.S Primary objective: To determine the proportions of NVAF patients with bleeding-related hospital readmissions that occur within 30 days of the hospitalization of NVAF patients treated with the new oral anticoagulants (NOACs), dabigatran, rivaroxaban, apixaban or warfarin in the inpatient setting Secondary objectives: To determine the cost associated with bleeding-related hospital readmissions that occur within 30 days of the hospitalization of NVAF patients treated with dabigatran, rivaroxaban, apixaban or warfarin in the inpatient setting To determine the proportions of NVAF patients with all cause hospital readmissions and the associated costs that occur within 30 days of the hospitalization of NVAF patients treated with dabigatran, rivaroxaban, apixaban or warfarin in the inpatient setting.

Official Title
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An Early Evaluation of 30-Day Readmissions Among Nonvalvular Atrial Fibrillation (NVAF) Patients Treated With Dabigatran, Rivaroxaban, Apixaban, or Warfarin in the US

Conditions
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Nonvalvular Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a primary or secondary diagnosis of AF identified by International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes from the Premier Hospital database between January 1, 2012 and December 31, 2013 Age 18 years or older as of initial hospitalization with AF diagnosis Exclusion Criteria: Have any primary or secondary diagnosis code or procedure code for valvular disease during the study period. This exclusion criterion is consistent with that used in other previous BMS HEOR studies and is used to ensure that the study populations are NVAF patients Received multiple types of NOACs during the index hospitalization. Preliminary analysis showed that very few patients receive multiple types of new oral anticoagulants (NOACs) during the same hospitalization. This exclusion criterion will allow to cleanly group patients into the different NOAC usage groups

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 |
| --- | --- |
| Patient treated with Dabigatran<br> | |
| Patient treated with Rivaroxaban<br> | |
| Patient treated with Apixaban<br> | |
| Patient treated with Warfarin<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportions of NVAF patients with bleeding related hospital readmissions that occur within 30 days of the hospitalization of NVAF patients treated with the NOACs, dabigatran, rivaroxaban, apixaban, or warfarin in the inpatient setting |  | 30 days post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cost associated with bleeding-related hospital readmissions that occur within 30 days of the hospitalization of NVAF patients treated with dabigatran, rivaroxaban, apixaban, or warfarin in the inpatient setting |  | 30 days post treatment | 
| Proportions of NVAF patients with all cause hospital readmissions that occur within 30 days of the hospitalization of NVAF patients treated with dabigatran, rivaroxaban, apixaban or warfarin in the inpatient setting |  | 30 days post treatment | 
| Associated costs that occur within 30 days of the hospitalization of NVAF patients treated with dabigatran, rivaroxaban, apixaban or warfarin in the inpatient setting |  | 30 days post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anticoagulation