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

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

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.

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