Real-world Comparative Effectiveness of Dabigatran Versus Vitamin K Antagonist (DABI-F)

Bayer

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Drug: Dabigatran (Pradaxa)

Drug: Vitamin K antagonist

Study type

Observational

Funder types

Industry

Identifiers

NCT02687867

NN1513US (Other Identifier)

18732

Details and patient eligibility

About

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

Enrollment

56,039 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Non-valvular atrial fibrillation will be defined as the occurrence of 2 or more inpatient or outpatient claims with ICD-9 427.31 (International Classification of Disease, Ninth Revision, Clinical Modification) 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 (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 dabigatran use baseline period

Exclusion criteria

Patients <18 years of age
Patients with valvular Atrial fibrillation
Pregnancy
Malignant cancers
Transient cause of Atrial fibrillation
Patients with Venous thromboembolism (pulmonary embolism or Deep Vein Thrombosis)
Patients with major surgery defined as hip or knee replacement
Prescriptions of Oral anticoagulants (OACs) {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