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

Bristol-Myers Squibb (BMS)

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Drug: Warfarin

Drug: Apixaban

Drug: Dabigatran

Drug: Rivaroxaban

Study type

Observational

Funder types

Industry

Identifiers

NCT03189069

CV185-583

Details and patient eligibility

About

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.

Enrollment

36,000 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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