Clinical Outcomes Among Non-valvular Atrial Fibrillation Patients With Renal Dysfunction

Study Overview
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Brief Summary
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The objective of the study is to evaluate the effectiveness and safety of the reduced dose rivaroxaban (15 mg once daily) as compared to warfarin in non-valvular atrial fibrillation (NVAF) patients with renal dysfunction in routine clinical practice. The study has a retrospective design, and will be conducted in the US Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases

Official Title
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Evaluation of Clinical Outcomes Among Non-valvular Atrial Fibrillation Patients With Renal Dysfunction Treated With Warfarin or Reduced Dose Rivaroxaban

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Rivaroxaban (Xarelto, BAY59-7939)
* Drug: Warfarin sodium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: have to be adults (≥18 years of age) newly-initiated on warfarin or rivaroxaban 15 mg (index event, index drug) have at least 365 days of continuous medical and prescription benefits prior to the index event (baseline period) have at least two diagnosis codes for NVAF (on outpatient or inpatient claims, at two different days) and have at least one diagnosis code (inpatient or outpatient) indicating renal dysfunction in the baseline period Exclusion Criteria: valvular AF (at least one inpatient diagnosis in the baseline period) pregnancy (inpatient or outpatient diagnosis in the baseline period) transient cause of AF (inpatient or outpatient diagnosis in the baseline period) venous thromboembolism (pulmonary embolism or deep vein thrombosis) (one inpatient or outpatient diagnosis 60 days prior to or on the index date) or overcame a hip or knee replacement (one inpatient diagnosis or procedure code 60 days prior to or on the index date) have a pharmacy claim for an oral anticoagulation (OAC) dispensation (warfarin, apixaban, dabigatran, edoxaban or rivaroxaban) in the baseline period receive both warfarin and rivaroxaban 15 mg on the index date have an end-stage kidney disease or be on dialysis (one inpatient or outpatient diagnosis or procedure code in the baseline period). For the main analysis, patients having malignant cancers (inpatient or outpatient diagnosis in the baseline period) will be excluded. A sensitivity analysis, omitting this exclusion criterion, will be performed.

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>NVAF patients with renal dysfunction newly initiated on rivaroxaban 15 mg for stroke prevention | Drug: Rivaroxaban (Xarelto, BAY59-7939)<br>* 15 mg, once daily<br>|
| Warfarin<br>NVAF patients with renal dysfunction newly initiated on vitamin K antagonist (warfarin) for stroke prevention | Drug: Warfarin sodium<br>* Individually adjusted dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemic stroke | The study outcomes will be defined based on the International Classification of Diseases, 9th- and 10th-revision, Clinical Modification (ICD-9/10-CM) diagnosis codes, Current Procedural Technology, 4th-revision (CPT-4) and Healthcare Common Procedure Coding System (HCPCS) procedure codes | Retrospective analysis from August 2011 to September 2017 | 
| Intracranial hemorrhage | The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes | Retrospective analysis from August 2011 to September 2017 | 
| Bleeding-related hospitalization | The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes, Cunningham algorithm | Retrospective analysis from August 2011 to September 2017 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint, which is defined as the occurrence of ischemic stroke or intracranial hemorrhage | The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes | Retrospective analysis from August 2011 to September 2017 | 
| Progression to stage 5 chronic kidney disease (CKD), kidney failure or need for dialysis | The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes | Retrospecitive analysis from August 2011 to September 2017 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Real-world study, Atrial fibrillation, Renal dysfunction, Rivaroxaban, Warfarin