The overall goal of this study was to evaluate the comparative safety and effectiveness of rivaroxaban vs. vitamin K antagonist (VKA) for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF) across risk profiles and comorbidities that reflect everyday clinical practice. The primary objective in this study was to evaluate the combined end point of stroke or systemic embolism (SSE), and major bleeding in NVAF patients treated with rivaroxaban vs. VKA.
Study Type
OBSERVATIONAL
Enrollment
78,517
15/20 mg
Individually adjusted dose
Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases
Multiple Locations, Washington, United States
Stroke or systemic embolism (SSE)
Time frame: Retrospective analysis from January 1, 2011 to December 31, 2017
Major bleeding
Without access to clinical information and event adjudication in administrative claims data, major bleeding will operationalized as hospital-related bleeding using a clinically validated algorithm
Time frame: Retrospective analysis from January 1, 2011 to December 31, 2017
Hemorrhagic stroke
Time frame: Retrospective analysis from January 1, 2011 to December 31, 2017
Ischemic stroke
Time frame: Retrospective analysis from January 1, 2011 to December 31, 2017
Subtypes of major bleeding
Time frame: Retrospective analysis from January 1, 2011 to December 31, 2017
Major adverse cardiovascular events (MACEs) and major adverse limb events (MALEs)
Time frame: Retrospective analysis from January 1, 2011 to December 31, 2017
Acute kidney injury
Time frame: Retrospective analysis from January 1, 2011 to December 31, 2017
Renal impairment
Time frame: Retrospective analysis from January 1, 2011 to December 31, 2017
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