Real-world Comparative Effectiveness of Stroke Prevention in Patients With Atrial Fibrillation Treated With Rivaroxaban vs. Vitamin k Antagonists

Bayer

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Drug: Phenprocoumon (branded and generics); Drug: Rivaroxaban (Xarelto, BAY597939)

Study type: Observational

Funder types: Industry

Identifiers

NCT02960880

18735

Details and patient eligibility

About

The aim of this study is to assess the real world comparative effectiveness of Rivaroxaban prescribed in non-valvular atrial fibrillation (NVAF) routine care patients in Germany.

Enrollment: 99,999 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• First dispense date of Rivaroxaban (15mg or 20mg - PZN based) or Phenprocoumon (PZN based) between January 1, 2012 and December 31, 2015
• At least two verified outpatient diagnoses or one inpatient diagnosis (main or secondary diagnosis) of NVAF (ICD-10 GM I48.0/I48.1/I48.2/I48.9) in the individual time frame of 4 quarters before the index date (pre-index period) or within the index quarter
• Patients will be required to have 4 quarters of enrollment for the assessment of baseline characteristics and be observable and insured in the database for at least one day after their individual index date (post-index period)
• ≥ 18 years of age

Exclusion criteria

• Patients with valvular AF [4 quarters prior to the index date]
• Pregnancy [4 quarters prior to index date]
• Malignant cancers [4 quarters prior to the index date or "condition after"]
• Transient cause of AF [4 quarters prior to index date]
• Patients with VTE (pulmonary embolism or DVT) [60 days before index]
• Patients with major surgery defined as hip or knee replacement [60 days before index]
• Prescriptions of OACs (Rivaroxaban, VKA, Dabigatran, Apixaban) before index date [4 quarters prior to index date]
• Patients receiving more than one anticoagulant substance (Apixaban, Dabigatran, Rivaroxaban or Phenprocoumon) or more than one dosage of a substance on the index date
• For sensitivity analysis : Patient with any of the events defined in the combined endpoints [4 quarters prior to index date or "condition after"
• Patients with dialysis [4 quarters prior to index date]

Trial design

99,999 participants in 2 patient groups

Rivaroxaban

Description:

NVAF patients who were newly initiated on Rivaroxaban for stroke prevention

Treatment:

Drug: Rivaroxaban (Xarelto, BAY597939)

Phenprocoumon

Description:

NVAF patients who were newly initiated on Phenprocoumon for stroke prevention

Treatment:

Drug: Phenprocoumon (branded and generics)