Real-World Comparative Observational Study in Non-Valvular Atrial Fibrillation Patients Using Oral Anticoagulants

Bristol-Myers Squibb321,182 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

321,182

Conditions

Atrial Fibrillation

Interventions

WarfarinDRUG

ApixabanDRUG

DabigatranDRUG

RivaroxabanDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Time to "First Major" Bleeding event

Time frame: Up to 25 months

Secondary Outcomes

Time to "First Any" Bleeding event

Time frame: Up to 25 months

Major Bleeding-Related Healthcare Utilization

(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 )

Time frame: Up to 25 months

Any Bleeding-Related Healthcare Utilization

(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 )

Time frame: Up to 25 months

Major Bleeding-Related direct medical cost

(Inpatient costs, Outpatient costs, and Emergency Room (ER) costs related to at least 1 major bleeding event)

Time frame: Up to 25 months

Any Bleeding-Related direct medical cost

(Inpatient costs, Outpatient costs, and Emergency Room (ER) costs related to at least 1 bleeding event)

Time frame: Up to 25 months

Data from ClinicalTrials.gov

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