Real-world Comparative Effectiveness of Rivaroxaban Versus VKA



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


Inclusion Criteria:

- NVAF(non-valvular atrial fibrillation) will be defined as the occurrence of 2 or more
inpatient or outpatient claims with ICD(International Classification of Disease)-9
427.31 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 score ≥2 during the 180 days prior to index rivaroxaban use baseline
period (CHA2DS2-Vasc: Diabetes mellitus; S2: prior Stroke or TIA or Thromboembolism;
V: Vascular disease; A: Age 65-74 years; Sc: Sex category)

Exclusion Criteria:

- Patients <18 years of age

- Patients with valvular AF (Atrial fibrillation)

- Pregnancy

- Malignant cancers

- Transient cause of AF

- 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

- Fatal bleeding

- Fatal Stroke/Myocardial infarction

- Intracranial hemorrhage

- Ischemic stroke

- Myocardial infarction
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