A Real-World Comparison of Safety and Effectiveness of Novel Oral Anti-Coagulant (NOAC) Naïve and Warfarin Naïve Non-Valvular Atrial Fibrillation (NVAF) Patients With Medicare Advantage Coverage

Study Overview
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Brief Summary
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The primary purpose of this study is to evaluate the risk of major bleeding and stroke/systemic embolism (SE) among novel oral anti-coagulant (OAC) naïve and warfarin naïve Medicare Advantage patients with non-valvular atrial fibrillation (NVAF) treated with apixaban, dabigatran, rivaroxaban, or warfarin.

Official Title
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Real-World Comparisons of Bleeding Among Novel Oral Anticoagulant (NOAC)-Naïve Non-Valvular Atrial Fibrillation (NVAF) Patients With Medicare Advantage Coverage, Who Newly Initiated Novel Oral Anticoagulation Therapies or Were Treated With Warfarin

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: Had at least 1 pharmacy claim for warfarin, apixaban, dabigatran, or rivaroxaban during the identification period (01-Jan-2013 through 31-Dec-2015) Had continuous health plan enrollment with medical and pharmacy benefits for 6 months pre-index date (baseline period) Had continuous health plan enrollment with medical and pharmacy benefits for at least 1 month following index date Had at least 1 medical claim for atrial fibrillation any time before or on index date Exclusion Criteria: Had medical claims with a diagnosis code for rheumatic mitral valvular heart disease, mitral valve stenosis or heart valve replacement/transplant during the 6-month baseline period Had medical claims with a diagnosis code for dialysis, kidney transplant, or end-stage chronic kidney disease during the 6 month baseline period Had medical claims indicating a diagnosis of venous thromboembolism during the 6-month baseline period Had claims indicating a diagnosis or procedure code of hip or knee replacement surgery within 6 weeks prior to the index date Had claims for a diagnosis or procedure code for reversible atrial fibrillation Had medical claims indicating pregnancy during the study period Had a pharmacy claim for warfarin, apixaban, dabigatran, edoxaban, or rivaroxaban during the 6-month baseline period Had > 1 oral anticoagulant prescription claim on the 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 prescribed apixaban<br> | Drug: Apixaban<br>* Treatment for NVAF patients<br>|
| Patients prescribed dabigatran<br> | Drug: Dabigatran<br>* Treatment for NVAF patients<br>|
| Patients prescribed rivaroxaban<br> | Drug: Rivaroxaban<br>* Treatment for NVAF patients<br>|
| Patients prescribed warfarin<br> | Drug: Warfarin<br>* Treatment for NVAF patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major bleeding |  | 36 months |