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 identification

• EU PAS number:
  EUPAS11521
• Study ID:
  49831
• Official title and acronym:
  Benefit and risk of AntiThrombotic Treatments after Orthopaedic Surgery in real-life settings: a cohort study in the SNIIRAM claims and hospitalisation database (ATTOS)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  Eliquis® (apixaban), an antithrombotic agent has obtained market authorization in the indication “Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip or knee replacement surgery (THR or TKR)”. In this context, the French Transparency Commission requested a cohort study of patients treated in France by Eliquis® under real-life condition. To adress the HAS request, an historical cohort study will be formed using a national healthcare claims (SNIIRAM) linked to the national hospital-discharge summaries database. This cohort will include all adults with an antithrombotic agent reimbursement within one week after discharge for an orthopaedic procedure (THR, TKR and other orthopaedic procedures) between 1 January 2013 and 30 September 2014, and with a 3-year database history and a follow-up of 3 months. The primary objectives of the study are 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, a TKR, and after another orthopaedic procedure over a 3-month post-surgery period, according to the initial antithrombotic treatment. The secondary objectives are to estimate the cumulative incidence of all-cause death after a THR, after a TKR, and after another orthopaedic procedure, to compare cumulative incidence of VTE, of clinically significant bleeding, and of all-cause death over a 3-month post surgery period between Eliquis® and other antithrombotic, to describe the treated population, to describe conditions of Eliquis® use and other antithrombotic treatments, and to assess the impact of each antithrombotic treatment on the healthcare system during the study period. The statistical analysis will be performed separately for THR, TKR, and other orthopaedic procedures, according to the treatment group (first antithrombotic agent dispensed within a week after discharge).
• Study status:
  Finalised

Research institutions and networks

Institutions

Bordeaux PharmacoEpi, University of Bordeaux

France

Study timelines

Date when funding contract was signed

Actual:17/04/2015

Study start date

Planned:01/04/2016

Actual:15/06/2016

Data analysis start date

Planned:31/05/2016

Actual:15/09/2016

Date of final study report

Planned:31/10/2016

Actual:29/05/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bristol-Myers Squibb

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable