Nonvalvular Atrial Fibrillation
Conditions
Brief summary
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.
Interventions
DRUGRivaroxaban (Xarelto, BAY59-7939)
15/20 mg
Individually adjusted dose
Sponsors
Janssen Research & Development, LLC
Bayer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stroke or systemic embolism (SSE) | Retrospective analysis from January 1, 2011 to December 31, 2017 | — |
| Major bleeding | Retrospective analysis from January 1, 2011 to December 31, 2017 | Without access to clinical information and event adjudication in administrative claims data, major bleeding will operationalized as hospital-related bleeding using a clinically validated algorithm |
Secondary
| Measure | Time frame |
|---|---|
| Subtypes of major bleeding | Retrospective analysis from January 1, 2011 to December 31, 2017 |
| Major adverse cardiovascular events (MACEs) and major adverse limb events (MALEs) | Retrospective analysis from January 1, 2011 to December 31, 2017 |
| Hemorrhagic stroke | Retrospective analysis from January 1, 2011 to December 31, 2017 |
| Renal impairment | Retrospective analysis from January 1, 2011 to December 31, 2017 |
| Acute kidney injury | Retrospective analysis from January 1, 2011 to December 31, 2017 |
| Ischemic stroke | Retrospective analysis from January 1, 2011 to December 31, 2017 |
Countries
United States
Outcome results
None listed