Oral Anticoagulant Discontinuation, Adherence Patterns, Hospitalizations and Costs in Non-Valvular Atrial Fibrillation (NVAF) Patients

Study Overview
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Brief Summary
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To describe the rate of discontinuation among Non-Valvular Atrial Fibrillation (NVAF) patients who were on warfarin and have switched to the Novel oral anticoagulants(NOACs).

Official Title
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Oral Anticoagulant Bleeding Rate and Discontinuation and Adherence Patterns in Non-Valvular Atrial Fibrillation (NVAF) Patients

Conditions
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Atrial Fibrillation

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals with NVAF who were on warfarin and have switched to the NOACs (dabigatran, rivaroxaban and apixaban) within the study period January 01, 2013 through March 31, 2014 Individuals ≥18 years old on the index date At least 1 year of baseline period with history of continuous warfarin use in the baseline period for at least 3 months immediately before the index date At least 1 diagnosis of AF in the 12 months prior to index date Continuous eligibility with medical and pharmacy benefits for at least 12 months before the index date through 1 month after the index date Exclusion Criteria: Individuals with a diagnosis of valvular heart disease or cardiac surgery during the 12 months prior to index date

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 naive to oral anticoagulant treatment<br>NVAF patients naïve to oral anticoagulant treatment (Naïve) | Drug: apixaban<br> <br> Drug: dabigatran<br> <br> Drug: rivaroxaban<br> <br> |
| patients with prior warfarin therapy<br>NVAF patients with prior warfarin therapy (Warfarin treated) | Drug: apixaban<br> <br> Drug: dabigatran<br> <br> Drug: rivaroxaban<br> <br> Drug: warfarin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discontinuation rate of patients with prior warfarin use |  | up to 31 months | 
| Rate of major bleeding events of patients with prior warfarin use |  | up to 31 months | 
| Rate of hospitalization due to major bleeding events of patients with warfarin use |  | up to 31 months | 
| Discontinuation rate of patients who were naïve to oral anticoagulant |  | up to 31 months | 
| Rate of major bleeding events of patients who were naïve to oral anticoagulant |  | up to 31 months | 
| Rate of hospitalization due to major bleeding events of patients who were naïve to oral anticoagulant |  | up to 31 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of All-Cause Hospitalization |  | up to 31 months | 
| Rate of Atrial Fibrillation(AF)-Related Hospitalization |  | up to 31 months | 
| Rate of All-Cause Any Rehospitalization |  | up to 31 months | 
| Rate of AF-Related Any Rehospitalization |  | up to 31 months | 
| Rate of All-Cause Early Hospitalization |  | up to 31 months | 
| Rate of AF-Related Early Hospitalization |  | up to 31 months | 
| All-Cause Healthcare per patient per month (PPPM) cost |  | up to 31 months | 
| AF-related Healthcare per patient per month (PPPM) cost |  | up to 31 months |