A Study Using Electronic Health Information to Learn About Rivaroxaban Compared to Warfarin in Participants With Non-valvular Atrial Fibrillation (NVAF) and Diabetes

Study Overview
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Brief Summary
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In people with type 2 diabetes, the body does not make enough of a hormone called insulin or does not use insulin well. This results in high blood sugar levels. People with diabetes are more likely to have non-valvular atrial fibrillation (NVAF) compared to people who do not have diabetes. Having both NVAF and diabetes can increase the chances of developing other serious health conditions, like blood clots and strokes. People with NVAF may receive treatments to help lower the risk of blood clots. This can then help to lower the risk of having a stroke. Two of these treatments are rivaroxaban and warfarin. In this study, the researchers will look at how well rivaroxaban works and how safe it is compared to warfarin in routine clinical practice. The study will include men and women who are at least age 18 and who have NVAF and type 2 diabetes. The researchers in this study will use the participants' health information from an electronic database.

Official Title
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RIVA-DM: Effectiveness and Safety of Rivaroxaban vs. Warfarin in Nonvalvular Atrial Fibrillation and Diabetes Mellitus: Analysis of Electronic Health Record Data

Conditions
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Atrial Fibrillation

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be ≥18 years of age at the time of anticoagulation initiation Have diagnoses of type 2 diabetes and Non-valvular atrial fibrillation (NVAF) Have no record of prior oral anticoagulant (OAC) use in the prior 12-months Newly initiated on Rivaroxaban or Warfarin (index date) Have ≥12-months of electronic health record (EHR) activity prior to the index date and received care documented in the EHR database from at least one provider in the 12-months prior Exclusion Criteria: Evidence of valvular heart disease defined as any rheumatic heart disease, mitral stenosis or mitral valve repair/replacement Pregnancy Use of rivaroxaban doses other than 15 mg once daily or 20 mg once daily or the presence of other indication(s) for OAC use Any prior OAC utilization per written prescription or self-report at baseline

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 |
| --- | --- |
| Group A<br>Participants with diagnoses of type 2 diabetes and non-valvular atrial fibrillation (NVAF) newly-initiated on rivaroxaban | Drug: Rivaroxaban (Xarelto, BAY59-7939)<br>* Participants receive rivaroxaban (per written prescription, medication administration or self-report of medication use)<br>|
| Group B<br>Participants with diagnoses of type 2 diabetes and non-valvular atrial fibrillation (NVAF) newly-initiated on warfarin | Drug: Warfarin<br>* Participants receive warfarin (per written prescription, medication administration or self-report of medication use)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of stroke or systemic embolism |  | Up to 8 years | 
| Any major or clinically-relevant nonmajor bleed resulting in hospitalization |  | Up to 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemic stroke |  | Up to 8 years | 
| Systemic embolism |  | Up to 8 years | 
| Need for revascularization or major amputation of the lower limb |  | Up to 8 years | 
| Intracranial hemorrhage |  | Up to 8 years | 
| Critical organ bleeding per ISTH categories | The categories for critical organ bleeding as per ISTH definition are: intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome. | Up to 8 years | 
| Any extracranial bleeding |  | Up to 8 years | 
| Any hospitalization due to intracranial or critical organ bleeding or a bleed in another location associated with either a 2 g/dL drop in hemoglobin or need for transfusion |  | Up to 8 years | 
| Doubling of the serum creatinine level from baseline |  | Up to 8 years | 
| Decrease in eGFR>30% or 40% | Glomerular filtration rate (GRF) | Up to 8 years | 
| Development of an eGFR<15 mL/min or initiation of dialysis | Glomerular filtration rate (GRF) | Up to 8 years | 
| Development of end-stage renal disease per billing codes only |  | Up to 8 years | 
| Development of urine albumin-to-creatinine ratio (UACR) of 30-300 or >300 |  | Up to 8 years | 
| Development of serum potassium > 5.6 or >6 mg/dL |  | Up to 8 years | 
| Development of diabetic retinopathy |  | Up to 8 years | 
| Myocardial infarction |  | Up to 8 years | 
| All-cause mortality |  | Up to 8 years | 
| Vascular mortality |  | Up to 8 years | 
| Major adverse cardiovascular event |  | Up to 8 years | 
| Composite of stroke, systemic embolism, vascular death |  | Up to 8 years | 
| Composite of stroke, systemic embolism, myocardial infarction, vascular death |  | Up to 8 years | 
| Composite stroke, systemic embolism, need for lower limb revascularization or major amputation |  | Up to 8 years | 
| Composite of >40% decrease in eGFR from baseline, eGFR<15 mL/minute, need for dialysis, renal transplant, major adverse limb event, retinopathy or all-cause death | Glomerular filtration rate (GRF) | Up to 8 years | 
| New-onset vascular dementia |  | Up to 8 years |