Atrial Fibrillation
Conditions
Keywords
Real-world study, Atrial fibrillation, Renal dysfunction, Rivaroxaban, Warfarin
Brief summary
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
Interventions
DRUGRivaroxaban (Xarelto, BAY59-7939)
15 mg, once daily
DRUGWarfarin sodium
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ischemic stroke | Retrospective analysis from August 2011 to September 2017 | 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 |
| Intracranial hemorrhage | Retrospective analysis from August 2011 to September 2017 | The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes |
| Bleeding-related hospitalization | Retrospective analysis from August 2011 to September 2017 | The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes, Cunningham algorithm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite endpoint, which is defined as the occurrence of ischemic stroke or intracranial hemorrhage | Retrospective analysis from August 2011 to September 2017 | The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes |
| Progression to stage 5 chronic kidney disease (CKD), kidney failure or need for dialysis | Retrospecitive analysis from August 2011 to September 2017 | The study outcomes will be defined based on ICD-9/10-CM diagnosis codes, CPT-4 and HCPCS procedure codes |
Countries
United States
Outcome results
None listed