Benefit and risk of AntiThrombotic Treatments after Orthopaedic Surgery in real-life settings: a cohort study in the SNIIRAM claims and hospitalisation database (ATTOS)

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

  Drug utilisation

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (B01A) ANTITHROMBOTIC AGENTS

  ANTITHROMBOTIC AGENTS

  (B01AF02) apixaban

  apixaban
• Medical condition to be studied:
  Orthopaedic procedure

  Venous thrombosis

Population studied

• Short description of the study population:
  Adults patients with venous thromboembolic events (VTE) identified from the national healthcare claims data base (SNIIRAM) who had undergone elective total hip or knee replacement surgery (THR or TKR) and has been treated with Eliquis® (apixaban) between 1 January 2013 and 30 September 2014.
• 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:
  Patients with orthopaedic procedure and venous thrombosis
• Estimated number of subjects:
  300000

Study design details

• Main study objective:
  To estimate the cumulative incidence of VTE (effectiveness) and the cumulative incidence of clinically significant bleeding (safety) in real-life clinical settings in France after a THR, after a TKR, and after another orthopaedic procedure over a 3-month post-surgery period, according to the initial antithrombotic treatment.
• Outcomes:
  Primary effectiveness outcome: VTE defined as a main diagnosis of pulmonary embolism or deep vein thrombosis (effectiveness) in hospital-discharge summaries over a 3-month period after index date. Primary safety outcome: Clinically significant bleeding defined as main diagnosis of bleeding (safety), in hospital-discharge summaries over a 3-month period after index date. Secondary effectiveness outcome: VTE defined as primary effectiveness criteria or new dispensation of a Low-Molecular-Weight Heparin following a specific examination for pulmonary embolism or VTE, over a 3-month period after index date.All-cause death defined as any cause of death over 3-month period after index date.
• Data analysis plan:
  Statistical analysis will be performed using SAS® software. A Statistical Analysis Plan will be developed and validated by the Scientific Committee before analysis.The statistical analysis will be performed separetely for THR, TKR and other orthopaedic procedures, according to the treatment group.The analysis will describe the cumulative incidence of primary/secondary effectiveness endpoint and primary safety endpoint, the patient and disease characteristics, the conditions of Eliquis® and other antithrombotic agent use, the healthcare consumption, and compared outcomes between Eliquis® and other antithrombotic agents,For primary outcomes, a more sensitive definition using main, related, or associated diagnosis will be used for sensitivity analysis.