Real-world Comparative Effectiveness of Apixaban Versus Vitamin K Antagonist (PIXI-F)

Bayer

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Drug: Apixaban

Drug: Vitamin K antagonist

Study type

Observational

Funder types

Industry

Identifiers

NCT02687854

18731

Details and patient eligibility

About

To obtain a better understanding on the comparative effectiveness of apixaban versus VKA (Vitamin K antagonist) for stroke prevention in patients with NVAF (Non-valvular atrial fibrillation) in a real-life setting.

Enrollment

18,591 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

NVAF will be defined as the occurrence of 2 or more inpatient or outpatient claims with ICD-9 427.31 as the diagnosis code at any time in the patient's data history prior to inclusion
Patients will be required to have 180 days of enrollment for the assessment of baseline characteristics
CHA2DS2-Vasc (C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years; D: Diabetes mellitus; S2: prior Stroke or TIA or Thromboembolism; V: Vascular disease; A: Age 65-74 years; Sc: Sex category) score ≥2 during the 180 days prior to index apixaban use baseline period

Exclusion criteria

Patients <18 years of age
Patients with valvular AF (Atrial fibrillation)
Pregnancy
Malignant cancers
Transient cause of AF
Patients with VTE (Venous thromboembolism) (pulmonary embolism or DVT (Deep Vein Thrombosis))
Patients with major surgery defined as hip or knee replacement
Prescriptions of OACs (Oral anticoagulants) (apixaban, warfarin, dabigatran, rivaroxaban) before index date
Prescription of more than one OAC on the index date
Patient with any of the events defined in the composite endpoint