Real-world Comparisons of Stroke, Major Bleeding, Myocardial Infarction, Acute Limb Ischemia and Death among Non-Valvular Atrial Fibrillation Patients Diagnosed With Coronary Artery Disease/Peripheral Arterial Disease who Initiated Oral Anticoagulation Therapies (CAD PAD)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

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

Study drug and medical condition

• Name of medicine:
  ELIQUIS

  PRADAXA

  XARELTO
• Name of medicine, other:
  Coumadin
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Short description of the study population:
  Adult patients who were prescribed oral anticoagulants were selected from the Medicare database between January 1, 2013 and December 31, 2014 or until the last date of the data cut available at the time of execution of the study.
• Age groups:
  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:
  Patients with atrial fibrillation
• Estimated number of subjects:
  10000

Study design details

• Main study objective:
  The main objective of this study is to collect and analyze clinical and cost-related outcome measures for treatment naïve NVAF patients on either apixaban or warfarin using a US claims database.
• Outcomes:
  Bleeding-related outcomes, Health resource utilization/cost outcomes
• Data analysis plan:
  Descriptive analyses, including means, medians, and standard deviations will be conducted for continuous variables. Numbers and percentages will be provided for dichotomous and polychotomous variables. Bivariate comparisons of baseline characteristics and outcomes measures will be provided. Appropriate tests will be used based on the distribution of the measure. The cumulative incidence rate for clinical outcomes will be calculated. Multivariate analysis or propensity score matching will be conducted.