Real-world Comparative Effectiveness of Dabigatran Versus Vitamin K Antagonist



Status:Completed
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/6/2017
Start Date:February 12, 2016
End Date:March 1, 2016

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Real-world Comparative Effectiveness of Dabigatran Versus VKA

To obtain a better understanding on the comparative effectiveness of dabigatran versus
Vitamin K antagonist (VKA) for stroke prevention in patients with Non-valvular atrial
fibrillation (NVAF) in a real-life setting.


Inclusion Criteria:

- Non-valvular atrial fibrillation will be defined as the occurrence of 2 or more
inpatient or outpatient claims with ICD-9 427.31 (International Classification of
Disease, Ninth Revision, Clinical Modification) as the diagnosis code at any time in
the patient's data history prior to inclusion

- Patients will be required to have 180 days of enrollment for the assessment of
baseline characteristics

- CHA2DS2-Vasc (Diabetes mellitus; S2: prior Stroke or TIA or Thromboembolism; V:
Vascular disease; A: Age 65-74 years; Sc: Sex category ) score ≥2 during the 180 days
prior to index dabigatran use baseline period

Exclusion Criteria:

- Patients <18 years of age

- Patients with valvular Atrial fibrillation

- Pregnancy

- Malignant cancers

- Transient cause of Atrial fibrillation

- Patients with Venous thromboembolism (pulmonary embolism or Deep Vein Thrombosis)

- Patients with major surgery defined as hip or knee replacement

- Prescriptions of Oral anticoagulants (OACs) {apixaban, warfarin, dabigatran,
rivaroxaban} before index date

- Prescription of more than one OAC on the index date

- Patient with any of the events defined in the composite endpoint
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