Atrial Fibrillation
Conditions
Brief summary
The purpose of this study is to compare the risk of major bleeding event among nonvalvular atrial fibrillation patients treated with warfarin, apixaban, dabigatran and rivaroxaban.
Interventions
DRUGWarfarin
DRUGApixaban
DRUGDabigatran
DRUGRivaroxaban
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients ≥18 years old as of the index date * At least 1 diagnosis of atrial fibrillation in the 12 months prior to or on index date, identified by any medical claim * At least one year of baseline period and continuous enrollment for at least 12 months prior to index date Individuals with NVAF who were using oral anticoagulants (i.e., warfarin, dabigatran, rivaroxaban and apixaban) within the study period beginning Jan 1, 2012 through December 31, 2013 or last date of the last data cut available at the time of execution of the study
Exclusion criteria
* Patients with evidence of valvular heart disease, thyrotoxicosis, pericarditis, mitral stenosis, Venous thromboembolism(VTE), heart surgery, and endocarditis during the baseline period any time prior to or on index date * Patients with any evidence of pregnancy at any time during the baseline will be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to First Major Bleeding event | Up to 25 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Any Bleeding event | Up to 25 months | — |
| Major Bleeding-Related Healthcare Utilization | Up to 25 months | (Number of Hospitalizations, Total Length of Hospital Stay (days), Time to Hospitalization, Number Of Emergency Room (ER) visits, and Number of Outpatient Visits with at least 1 major bleeding event ) |
| Any Bleeding-Related Healthcare Utilization | Up to 25 months | (Number of Hospitalizations, Total Length of Hospital Stay (days), Time to Hospitalization, Number Of Emergency Room (ER) visits, and Number of Outpatient Visits with at least 1 bleeding event ) |
| Major Bleeding-Related direct medical cost | Up to 25 months | (Inpatient costs, Outpatient costs, and Emergency Room (ER) costs related to at least 1 major bleeding event) |
| Any Bleeding-Related direct medical cost | Up to 25 months | (Inpatient costs, Outpatient costs, and Emergency Room (ER) costs related to at least 1 bleeding event) |
Outcome results
None listed