Comparative risk of major bleeding with new oral anticoagulants (NOACs) and Phenprocoumon in patients with atrial fibrillation – effectiveness analyses added (CARBOS E+)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• 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

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

  DABIGATRAN ETEXILATE

  RIVAROXABAN

  PHENPROCOUMON
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Short description of the study population:
  1. Adult atrial fibrillation (AF) patients who have newly initiated a oral anticoagulants (OAC) therapy (apixaban, dabigatran, rivaroxaban, edoxaban2 or phenprocoumon) within the study period (01.01.2013 - 31.12.20153), i.e. no prior prescription for any of the above listed substances in the 12 months before the first prescription in the study period; 2. Have an ambulatory verified or primary or secondary hospital discharge diagnosis of AF (ICD-10 GM I48.0/ I48.1/I48.2/I48.9) in the previous or same quarter of the index date
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with atrial fibrillation
• Estimated number of subjects:
  60500

Study design details

• Main study objective:
  Investigate whether the occurrence of strokes/SE and major bleeding events in AF patients under anticoagulant therapy differs between patients treated with VKA and patients treated with NOACS.
• Outcomes:
  Strokes or systemic embolism and major bleeding events, All StrokesIschemic strokeHaemorrhagic strokeAll-cause mortalityIntracranial bleedingGastrointestinal bleedingany bleeding events
• Data analysis plan:
  Adjusted hazard ratios of the primary and secondary endpoints will be estimated by means of (i) a cox-proportional hazards model, (ii) propensity score matching analysis and (iii) a marginal structural model (MSM) accounting treatment switching, for time-varying confounders and exposures