Replication Of An Early Evaluation Of 30-Day Readmissions Among Nonvalvular Atrial Fibrillation Patients Treated With Dabigatran, Rivaroxaban, Apixaban, or Warfarin In The U.S

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.

Official Title
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Replication Of An Early Evaluation Of 30-Day Readmissions Among Nonvalvular Atrial Fibrillation Patients Treated With Dabigatran, Rivaroxaban, Apixaban, or Warfarin In The U.S

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: dabigatran
* Drug: rivaroxaban
* Drug: apixaban
* Drug: warfarin


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 Cerner Health Facts hospital database between January 1, 2012 and August 31, 2014 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 Health Economics and Outcomes Research (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 NOACs during the same hospitalization. This exclusion criterion will allow to cleanly group patients into the different New oral anticoagulant (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 |
| --- | --- |
| Patients who received dabigatran<br>Patients who received dabigatran | Drug: dabigatran<br> <br> |
| Patients who received rivaroxaban<br>Patients who received rivaroxaban | Drug: rivaroxaban<br> <br> |
| Patients who received apixaban<br>Patients who received apixaban | Drug: apixaban<br> <br> |
| Patients who received warfarin<br>Patients who received warfarin | Drug: warfarin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of NVAF patients with bleeding-related hospital readmissions from inpatient hospitalization records collected from the Cerner Health Facts hospital database | Proportion of NVAF patients 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. | January 1, 2012 to August 31, 2014 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost associated with bleeding-related hospital readmissions from inpatient hospitalization records collected from the Cerner Health Facts hospital database | 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 | January 1, 2012 to August 31, 2014 | 
| Proportion of NVAF patients with all cause hospital readmissions and the associated costs from inpatient hospitalization records collected from the Cerner Health Facts hospital database | Proportion 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. | January 1, 2012 to August 31, 2014 | 

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