Beyond Pooled – Part of the BEYOND study program (Benefit of NOACs study of non-valvular AF patients in nordic countries) (BEYOND Pooled (Denmark, Norway, Sweden))

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

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  ELIQUIS

  PRADAXA

  XARELTO
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Short description of the study population:
  Treatment-naïve adults in the source population diagnosed with Atrial fibrillation (AF), with a dispensing of apixaban, rivaroxaban or dabigatran (‘the NOACs’) or warfarin during the study population identification period.; ; Patients had to meet all of the following inclusion criteria on the index date:; • Be alive and of age 18 years or older;; • A dispensing of apixaban, dabigatran, rivaroxaban, or warfarin between 01 January 2013 and 31 December 2016;; • Diagnosis of AF recorded up to 5 years before or up to 60 days after the index date.
• 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:
  Atrial fibrillation patients
• Estimated number of subjects:
  20000

Study design details

• Main study objective:
  To evaluate effectiveness and safety of each NOAC compared with warfarin in treatment-naïve initiators of anticoagulants with NVAF in routine clinical practice in Denmark, Norway and Sweden.
• Outcomes:
  Stroke/systemic embolism and major bleeding. Ischaemic stroke, haemorrhagic stroke, major intracranial bleeding, major gastrointestinal bleeding, acute myocardial infarction, or death of any cause, any hospitalized bleeding, and composite outcome of ischemic stroke, systemic embolism, myocardial infarction, or all-cause mortality.
• Data analysis plan:
  To compare risks of the endpoints across the study cohorts, time to event analysis will be undertaken, using Cox proportional-hazards regression, with death as competing risk for endpoints not including death. Crude and adjusted hazard ratios (HRs) and 95% confidence intervals (CI) will be estimated for initiators of each NOAC. Follow-up will end on the date of a given endpoint, date of death (for non-death endpoints), date of discontinuation of or switch from the index OAC, date of emigration, or 31 December 2016, whichever comes first. A patient will be considered on-treatment from the date of initiation of the on-study OAC and for the subsequent number of days corresponding to the number of tablets in a package for rivaroxaban (used once daily) or half the number of tablets in a package for dabigatran and apixaban (used twice daily).