Rivaroxaban vs Warfarin for SPAF in Multi-morbid Patients

Study Overview
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Brief Summary
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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.

Official Title
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Comparative Effectiveness of Rivaroxaban and Warfarin for Stroke Prevention in Multi-morbid Patients With Nonvalvular Atrial Fibrillation

Conditions
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Nonvalvular Atrial Fibrillation

Intervention / Treatment
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* Drug: Rivaroxaban (Xarelto, BAY59-7939)
* Drug: Vitamin K antagonist (VKA)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rivaroxaban<br>Patients who initiated Oral anticoagulant (OAC) treatment with rivaroxaban | Drug: Rivaroxaban (Xarelto, BAY59-7939)<br>* 15/20 mg<br>|
| Vitamin K antagonist (VKA)<br>Patients who initiated OAC treatment with VKA | Drug: Vitamin K antagonist (VKA)<br>* Individually adjusted dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke or systemic embolism (SSE) |  | Retrospective analysis from January 1, 2011 to December 31, 2017 | 
| Major bleeding | 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 | Retrospective analysis from January 1, 2011 to December 31, 2017 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemorrhagic stroke |  | Retrospective analysis from January 1, 2011 to December 31, 2017 | 
| Ischemic stroke |  | Retrospective analysis from January 1, 2011 to December 31, 2017 | 
| 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 | 
| Acute kidney injury |  | Retrospective analysis from January 1, 2011 to December 31, 2017 | 
| Renal impairment |  | Retrospective analysis from January 1, 2011 to December 31, 2017 |