Real-world Comparative Effectiveness of Rivaroxaban Versus VKA (RIVA-F)

Bayer

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: VKA (Vitamin K antagonist)

Study type: Observational

Funder types: Industry

Identifiers

NCT02690155

18734

Details and patient eligibility

About

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

Enrollment: 38,831 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• NVAF(non-valvular atrial fibrillation) will be defined as the occurrence of 2 or more inpatient or outpatient claims with ICD(International Classification of Disease)-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 score ≥2 during the 180 days prior to index rivaroxaban use baseline period (CHA2DS2-Vasc: Diabetes mellitus; S2: prior Stroke or TIA or Thromboembolism; V: Vascular disease; A: Age 65-74 years; Sc: Sex category)

Exclusion criteria

• Patients <18 years of age

• Patients with valvular AF (Atrial fibrillation)

• Pregnancy

• Malignant cancers

• Transient cause of AF

• 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

  • Fatal bleeding
  • Fatal Stroke/Myocardial infarction
  • Intracranial hemorrhage
  • Ischemic stroke
  • Myocardial infarction

Trial design

38,831 participants in 2 patient groups

Rivaroxaban

Description:

NVAF patients who were initiated on rivaroxaban for stroke prevention

Treatment:

Drug: Rivaroxaban (Xarelto, BAY59-7939)

VKA (Vitamin K antagonist)

Description:

NVAF patients who were initiated on VKA for stroke prevention

Treatment:

Drug: VKA (Vitamin K antagonist)