Comparative effectiveness of rivaroxaban and warfarin for stroke prevention in multi-morbid patients with nonvalvular atrial fibrillation

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  RIVAROXABAN
• Anatomical Therapeutic Chemical (ATC) code:
  100000094255

  warfarin
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Short description of the 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).; To be included in this study patients would have to:; • 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)
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Non-valvular atrial fibrillation (NVAF) patients
• Estimated number of subjects:
  99999

Study design details

• Main study objective:
  The primary objective in this study is to evaluate the combined end point of stroke or systemic embolism (SSE), and major bleeding in NVAF patients treated with rivaroxaban vs. VKA.
• Outcomes:
  1.Stroke2.Systemic embolism3.Major bleeding, 1.Hemorrhagic stroke2.Ischemic stroke3.Subtypes of major bleeding
• Data analysis plan:
  Baseline patient characteristics will be analyzed using descriptive statistics. Categorical data will be reported as proportions, while continuous data will be reported as means±standard deviations or medians with interquartile ranges.The incidence of primary and secondary study end points will be reported as the number of events per 100 person-years anticoagulant exposure and calculated as the number of patients with ≥1 documented event divided by each respective cohorts’ time at risk. Cox proportional hazards regression will be performed on the matched cohorts and results reported as hazard ratios and 95% confidence intervals.Individuals enrolled in the MarketScan databases are largely representative of the United States population in terms of age, sex, and type of health insurance coverage.While the MarketScan claims databases are based on a large sample it may contain biases or fail to generalize well to other populations.

Documents

Study results

19859_EU PAS Abstract_Redacted_V1.0_2020-07-07

Study report

19859_Clinical Study Report_Redacted_V 1.0_2020-07-07