Atrial Fibrillation
Conditions
Brief summary
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.
Interventions
DRUGRivaroxaban (Xarelto, BAY59-7939)
Participants receive rivaroxaban (per written prescription, medication administration or self-report of medication use)
DRUGWarfarin
Participants receive warfarin (per written prescription, medication administration or self-report of medication use)
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 ≥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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Ischemic stroke | Up to 8 years | — |
| Systemic embolism | Up to 8 years | — |
| Critical organ bleeding per ISTH categories | Up to 8 years | The categories for critical organ bleeding as per ISTH definition are: intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome. |
| 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% | Up to 8 years | Glomerular filtration rate (GRF) |
| Development of an eGFR<15 mL/min or initiation of dialysis | Up to 8 years | Glomerular filtration rate (GRF) |
| 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 | — |
| Need for revascularization or major amputation of the lower limb | 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 | Up to 8 years | Glomerular filtration rate (GRF) |
| New-onset vascular dementia | Up to 8 years | — |
| Development of serum potassium > 5.6 or >6 mg/dL | Up to 8 years | — |
| Intracranial hemorrhage | Up to 8 years | — |
Countries
United States
Outcome results
None listed