The Comparative Safety and Effectiveness of Dabigatran, Versus Rivaroxaban, and Apixaban Utilized in the Department of Defense Non-Valvular Atrial Fibrillation Patient Population: A Retrospective Database Analysis



Status:Completed
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:9/27/2017
Start Date:December 29, 2016
End Date:August 23, 2017

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Safety and Effectiveness Study Comparing Dabigatran, Rivaroxaban & Apixaban in Non-valvular Atrial Fibrillation Patients Enrolled in the US Department of Defense Military Health System

The purpose of this study is to assess the safety and effectiveness of newly initiated
dabigatran among patients diagnosed with non valvular atrial fibrillation (NVAF) in
comparison to newly initiated rivaroxaban users and newly initiated apixaban users


Inclusion Criteria:

- Age 18+ on index date

- Patients must have been prescribed either dabigatran, rivaroxaban, or apixaban
identified by pharmacy claim during the study period. The first dispensing date of
either study drug will be defined as the index date;

- Patients must be treatment naïve from all OAC use prior to the first NOAC
prescription, during study period.

- Patients must have at least 12 months of continuous eligibility prior to the index
date; -Patients must have at least one diagnosis code of atrial fibrillation, defined
as ICD- 9-CM diagnosis of 427.31 or ICD-10-CM diagnosis of I48.0, I48.1, I48.2, I48.91
on the index date or during the pre-index period.

Exclusion Criteria:

Less than 12 months of continuous eligibility in the pre-index period Any claim for OAC
drug (oral use only) in the pre-index period Diagnosis of hyperthyroidism during the
pre-index period Having at least one claim for alternative indications; orthopedic
procedures, VTE (includes DVT &PE) and the index NOAC prescription at the same time, or,
the alternative indication for anticoagulant occurring within 3 months prior to index date
in pre-period Having at least one claim with any of the following diagnoses or procedure
codes in order to exclude patients with "transient" causes of Afib (3 months prior to index
date in pre-period):

- Cardiac surgery

- Pericarditis

- Myocarditis Having at least one medical claim with any of the following diagnoses or
procedures codes in order to exclude patients with "valvular" Afib (pre-period):

- Mitral stenosis

- Mitral stenosis with insufficiency

- Mitral valve stenosis and aortic valve stenosis

- Mitral valve stenosis and aortic valve insufficiency

- Diseases of other endocardial structures

- Other and unspecified rheumatic heart diseases

- Open heart valvuloplasty without replacement

- Open and other replacement of unspecified heart valve

- Open and other replacement of aortic valve

- Open and other replacement of mitral valve

- Open and other replacement of pulmonary valve

- Open and other replacement of tricuspid valve

- Heart valve replaced by transplant

- Heart valve replaced by a mechanical device/prosthesis

- Atrioventricular valve repair

- Aortic valve valvuloplasty

- Unlisted procedure, cardiac surgery

- Implantation of catheter-delivered prosthetic aortic heart valve; open thoracic
approach

- Transthoracic cardiac exposure (e.g., sternotomy, thoracotomy, subxiphoid) for
catheter-delivered aortic valve replacement; without cardiopulmonary bypass

- Transthoracic cardiac exposure (e.g., sternotomy, thoracotomy, subxiphoid) for
catheter-delivered aortic valve replacement; with cardiopulmonary bypass

- Replacement, aortic valve, with cardiopulmonary bypass; with prosthetic valve other
than homograft or stentless valve

- Valvuloplasty, mitral valve, with cardiopulmonary bypass

- Valvuloplasty, mitral valve, with cardiopulmonary bypass; with prosthetic ring

- Valvuloplasty, mitral valve, with cardiopulmonary bypass; radical reconstruction, with
or without ring

- Replacement, mitral valve, with cardiopulmonary bypass

- Implantation of catheter-delivered prosthetic pulmonary valve, endovascular approach

- Replacement, pulmonary valve

- Valvectomy, tricuspid valve, with cardiopulmonary bypass

- Valvuloplasty, tricuspid valve; without ring insertion

- Valvuloplasty, tricuspid valve; with ring insertion

- Replacement, tricuspid valve, with cardiopulmonary bypass
We found this trial at
1
site
Princeton, New Jersey 08450
Phone: 978-525-8314
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Princeton, NJ
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