Clinical trial NCT03374540: Rivaroxaban vs Warfarin for SPAF in Multi-morbid Patients
Official title: Comparative Effectiveness of Rivaroxaban and Warfarin for Stroke Prevention in Multi-morbid Patients With Nonvalvular Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nonvalvular Atrial Fibrillation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2017-12-15
Enrollment: 78517
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The source population of this study will be all the insured individuals included in the Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases (Truven MarketScan).

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Be oral anticoagulant naive during the 365 days before the day of the first qualifying oral anticoagulant (rivaroxaban or VKA) dispensing, and
* Have ≥365 days of continuous medical and prescription coverage before initiation of oral anticoagulation (which serves as the study's baseline period)

Exclusion Criteria:

* \<18 years of age
* \<2 International Classification of Diseases, Ninth/Tenth Revision, Clinical Modification diagnosis codes for atrial fibrillation
* Valvular heart disease
* Transient cause of NVAF
* Venous thromboembolism
* Hip or knee arthroplasty
* Malignant cancer
* Pregnancy
* \>1 oral anticoagulant prescribed (on index date)

Primary outcomes:
measure: Stroke or systemic embolism (SSE)
timeFrame: Retrospective analysis from January 1, 2011 to December 31, 2017
measure: Major bleeding
timeFrame: Retrospective analysis from January 1, 2011 to December 31, 2017
Secondary outcomes:
measure: Hemorrhagic stroke
timeFrame: Retrospective analysis from January 1, 2011 to December 31, 2017
measure: Ischemic stroke
timeFrame: Retrospective analysis from January 1, 2011 to December 31, 2017
measure: Subtypes of major bleeding
timeFrame: Retrospective analysis from January 1, 2011 to December 31, 2017
measure: Major adverse cardiovascular events (MACEs) and major adverse limb events (MALEs)
timeFrame: Retrospective analysis from January 1, 2011 to December 31, 2017
measure: Acute kidney injury
timeFrame: Retrospective analysis from January 1, 2011 to December 31, 2017
measure: Renal impairment
timeFrame: Retrospective analysis from January 1, 2011 to December 31, 2017
Other outcomes:
Locations:
city: Multiple Locations
country: United States
facility: Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases
state: Washington
Study officials:
References:
citation: Coleman CI, Kreutz R, Sood N, Bunz TJ, Meinecke AK, Eriksson D, Baker WL. Rivaroxaban's Impact on Renal Decline in Patients With Nonvalvular Atrial Fibrillation: A US MarketScan Claims Database Analysis. Clin Appl Thromb Hemost. 2019 Jan-Dec;25:1076029619868535. doi: 10.1177/1076029619868535.
citation: Martinez BK, Baker WL, Sood NA, Bunz TJ, Meinecke AK, Eriksson D, Coleman CI. Influence of Polypharmacy on the Effectiveness and Safety of Rivaroxaban Versus Warfarin in Patients With Nonvalvular Atrial Fibrillation. Pharmacotherapy. 2019 Feb;39(2):196-203. doi: 10.1002/phar.2213. Epub 2019 Jan 28.
citation: Baker WL, Beyer-Westendorf J, Bunz TJ, Eriksson D, Meinecke AK, Sood NA, Coleman CI. Effectiveness and safety of rivaroxaban and warfarin for prevention of major adverse cardiovascular or limb events in patients with non-valvular atrial fibrillation and type 2 diabetes. Diabetes Obes Metab. 2019 Sep;21(9):2107-2114. doi: 10.1111/dom.13787. Epub 2019 Jun 11.
citation: Hernandez AV, Bradley G, Khan M, Fratoni A, Gasparini A, Roman YM, Bunz TJ, Eriksson D, Meinecke AK, Coleman CI. Rivaroxaban vs. warfarin and renal outcomes in non-valvular atrial fibrillation patients with diabetes. Eur Heart J Qual Care Clin Outcomes. 2020 Oct 1;6(4):301-307. doi: 10.1093/ehjqcco/qcz047.