Comparative risk of major bleeding with new oral anticoagulants (NOACs) and Phenprocoumon in patients with atrial fibrillation: a retrospective claims database study in Germany (CARBOS)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

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

Study drug and medical condition

• Name of medicine:
  ELIQUIS

  PRADAXA

  XARELTO
• Anatomical Therapeutic Chemical (ATC) code:
  (B01AA04) phenprocoumon

  phenprocoumon
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Short description of the study population:
  Insured patient who have been prescribed an oral anticoagulant (OAC) therapy within 01.01.2013 and 31.12.2014 because of documented non-valvular atrial fibrillation (NVAF) in the same or preceding quarter of treatment initiation.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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:
  Patients with atrial fibrillation
• Estimated number of subjects:
  36700

Study design details

• Main study objective:
  Investigate whether the occurrence of major bleeding events in AF patients under anticoagulant therapy differs between patients treated with VKA and patients treated with NOACS.
• Outcomes:
  Major bleeding events, Gastrointestinal bleedings eventsany bleeding events“net clinical” combined outcome consisting of stroke, systemic embolism, major bleeding or death from any cause
• Data analysis plan:
  Adjusted hazard ratios of the primary and secondary endpoints will be estimated by means of (i) a cox-proportional hazards model and (ii) a marginal structural model (MSM) accounting treatment switching, for time-varying confounders and exposures