Thromboembolic and Bleeding Risks of Apixaban, Rivaroxaban and Dabigatran versus Warfarin in Patients with Non-Valvular Atrial Fibrillation

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Longitudinal retrospective cohort analysis

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  WARFARIN

  APIXABAN

  DABIGATRAN

  RIVAROXABAN
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• 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)
• Estimated number of subjects:
  80000

Study design details

• Main study objective:
  Compare the safety and effectiveness for OAC treatment naïve patients prescribed dabigatran, rivaroxaban and apixaban or warfarin
• Outcomes:
  Several important effectiveness and safety endpoint will be analyzed, including stroke/ SE, major bleedings, mortality, ischemic stroke, systemic embolism, acute myocardial infarction, intracranial hemorrhage, GI bleeding and GU tract bleeding.
• Data analysis plan:
  All study variables, including baseline and outcome measures, will be analyzed descriptively. Percentages and standard deviations will be provided for dichotomous and polychotomous variables. Means, medians and standard deviations will be provided for continuous variables. The study cohorts will be compared for baseline clinical and demographic variables according to the objectives. Propensity Score Matching technique will be used to control for confounders when comparing the cohorts. Cox proportional hazards models will be used to compare the time-to-major bleeding, time-to-stroke, time-to-discontinuation, and time-to-switch between the apixaban, warfarin, rivaroxaban, and dabigatran cohorts.