TAVI versus classic aortic valve replacement (SAVR): real-life comparison using a health insurance dataset

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Aortic stenosis

Population studied

• 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)
• Estimated number of subjects:
  50000

Study design details

• Main study objective:
  This study aims to estimate clinical outcomes of two surgical procedures, surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI), in patients with aortic stenosis in Germany.
• Outcomes:
  The study will measure surgical outcomes based on an analysis of the following clinical events: death, transitory ischemic attack, hemorrhagic stroke, ischemic stroke, stroke, myocardial infarction, arterial embolism, bleeding, periprocedural complications, aortic insufficiency, implantation of a pacemaker, and follow-up aortic valve operations.
• Data analysis plan:
  The study will compare outcomes in two matched cohorts of patients who underwent aortic valve replacement surgery (either TAVI or SAVR) from 01/01/2014-30/09/2018. The two cohorts are composed of: (1) patients who received TAVI and (2) patients who received SAVR. Three main types of analyses will be conducted within the context of this study. The first consists of a descriptive analysis of events in both cohorts with an analysis of differences between TAVI and SAVR subgroups. Secondly, a basic analysis of outcomes (i.e. events and event frequency) will be conducted using propensity score matching. Lastly, a sensitivity analysis will be conducted using a multivariate analysis of unmatched groups to measure the time-to-events (using a Cox proportional hazards model) based on composite endpoints (i.e. death and cardiovascular hospitalizations).