Real-world comparative effectiveness of stroke prevention in patients with atrial fibrillation treated with Factor Xa nonvitamin-K oral anticoagulants (NOACs) vs. Phenprocoumon (ReLoaDeD)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Persistency
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

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

  APIXABAN

  EDOXABAN

  PHENPROCOUMON
• Medical condition to be studied:
  Arrhythmia

Population studied

• Short description of the study population:
  Patients with non-valvular atrial fibrillation (NVAF) and renal impairment initiating treatment with individual NOACs (rivaroxaban, apixaban, edoxaban).; The source population of this study will include all insured members of approximately 64 German statutory health insurances (SHIs) contributing data to the InGef database.
• 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:
  Renal impaired
• Estimated number of subjects:
  90000

Study design details

• Main study objective:
  The primary objectives of this study are to describe describe the risk of ischemic stroke (IS)/ systemic embolism (SE) and intracranial hemorrhage (ICH) in patients with non-valvular atrial fibrillation (NVAF) and renal impairment initiating treatment with individual NOACs (rivaroxaban, apixaban, edoxaban) compared to phenprocoumon and to assess the healthcare resource consumption and costs.
• Outcomes:
  - Risk of Ischemic stroke (IS) / Systemic embolism(SE) (as combined endpoint and alone), recurrent IS/SE (as combined endpoint), severe IS and intracranial hemorrhage (ICH) in patients with non-valvular atrial fibrillation (NVAF) and renal impairment determined by inpatient claims based diagnoses- Healthcare resource consumption and costs, - Risk of fatal bleeding, Kidney failure, Acute kidney injury (AKI) and IS, SE, Severe IS and recurrent IS/SE in patients with NVAF determined by inpatient claims based diagnoses- Risk of recurrent hospitalizations (in general and for IS/SE)- Risk of treatment discontinuation in patients with NVAF determined by pharmacy ClaimsThis study is registered under NCT03563937 on Clinicaltrials.gov
• Data analysis plan:
  Cox proportional hazards regression models will be applied in in each treatment group compared to phenprocoumon (reference) to estimate crude and confounder adjusted hazard ratios (HRs) of the above mentioned outcomes as well as treatment discontinuation with accompanying 95% confidence intervals and p-values. Kaplan-Meier cumulative incidence plots will be generated to characterize risk of outcome events of interest over time.In a second step, we will use the stabilized inverse probability of treatment weighting (IPTW) approach based on the propensity score to adjust for potential confounding resulting from imbalances in the baseline characteristics of different treatment groups.In a third step, we will additionally conduct a propensity score matched analyses for each comparison. A 1:1 matching will be performed using the nearest-neighbor approach with a caliper of 0.2 without replacement.

Documents

Study results

20031_EU PAS Abstract_2020-11-11

Study report

20031_OS_Report_V1.0_2020-07-31_redacted