Characterising the risk of major bleeding in patients with Non-Valvular Atrial Fibrillation: non-interventional study of patients taking Direct Oral Anticoagulants in the EU

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Short description of the study population:
  The study population consists of all new (D)OAC users aged ≥18 years and at least one year (365 days) register in the database with a recorded diagnosis of NVAF.
• 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:
  Hepatic impaired

  Other

  Renal impaired
• Special population of interest, other:
  Atrial fibrillation patients
• Estimated number of subjects:
  700000

Study design details

• Main study objective:
  Obj 1. The risk of major bleeding associated with use of DOACs when compared to other oral anticoagulants. Obj 2. The utilization of DOACs in the EU for treatment of NVAF. Obj 3. Prescribers’ compliance with recommendations included in sections 4.1 and 4.3-4.5 of the SmPC of each DOAC
• Outcomes:
  The risk of major bleeding, such as gastrointestinal bleeding, intracranial bleeding and haemorrhagic stroke, associated with use of DOACs AND Descriptive analysis of patient characteristics of new DOAC users, the number of patients switching to another antithrombotic agent and treatment duration. Prescriber compliance with recommendations included in SmPC section 4.1, 4.3, 4.4, and 4, Stroke, including ischaemic stroke and haemorrhagic stroke, and all‐cause mortality.
• Data analysis plan:
  Descriptive studies: The analysis will be descriptive using information on the index date. Stratified by database, individual DOACs, age group, gender, study period 2008-2015, calendar year: 2008, 2009, 2010, 2011, 2012, 2013, 2014 and 2015, Indication, Renal functionCohort study: Crude incidence rates of outcomes per 1,000 person years will be estimated, stratified by sex and age groups. Cox proportional hazard regression analysis will be applied to estimate effects (adjusted hazard ratios, HR) of (D)OAC treatment.