Rivaroxaban vs Warfarin for SPAF in Multi-morbid Patients

Bayer

Status: Completed

Conditions: Nonvalvular Atrial Fibrillation

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

Study type: Observational

Funder types: Industry

Identifiers

NCT03374540

19859

Details and patient eligibility

About

The overall goal of this study was to evaluate the comparative safety and effectiveness of rivaroxaban vs. vitamin K antagonist (VKA) for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF) across risk profiles and comorbidities that reflect everyday clinical practice.

The primary objective in this study was to evaluate the combined end point of stroke or systemic embolism (SSE), and major bleeding in NVAF patients treated with rivaroxaban vs. VKA.

Enrollment: 78,517 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be oral anticoagulant naive during the 365 days before the day of the first qualifying oral anticoagulant (rivaroxaban or VKA) dispensing, and
• Have ≥365 days of continuous medical and prescription coverage before initiation of oral anticoagulation (which serves as the study's baseline period)

Exclusion criteria

• <18 years of age
• <2 International Classification of Diseases, Ninth/Tenth Revision, Clinical Modification diagnosis codes for atrial fibrillation
• Valvular heart disease
• Transient cause of NVAF
• Venous thromboembolism
• Hip or knee arthroplasty
• Malignant cancer
• Pregnancy
• >1 oral anticoagulant prescribed (on index date)

Trial design

78,517 participants in 2 patient groups

Rivaroxaban

Description:

Patients who initiated Oral anticoagulant (OAC) treatment with rivaroxaban

Treatment:

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Vitamin K antagonist (VKA)

Description:

Patients who initiated OAC treatment with VKA

Treatment:

Drug: Vitamin K antagonist (VKA)