Health Outcomes, Resource Use, costs in patients with Stable coronary artery disease a cohort study in the EGB database (HORUS)

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

  Disease epidemiology

  Drug utilisation

  Healthcare resource utilisation
• 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:
  (A10) DRUGS USED IN DIABETES

  DRUGS USED IN DIABETES

  (B01AC) Platelet aggregation inhibitors excl. heparin

  Platelet aggregation inhibitors excl. heparin

  (C07) BETA BLOCKING AGENTS

  BETA BLOCKING AGENTS

  (C09A) ACE INHIBITORS, PLAIN

  ACE INHIBITORS, PLAIN

  (C09B) ACE INHIBITORS, COMBINATIONS

  ACE INHIBITORS, COMBINATIONS

  (C09C) ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN

  ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN

  (C09D) ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS

  ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS

  (C10) LIPID MODIFYING AGENTS

  LIPID MODIFYING AGENTS

  (N02BA01) acetylsalicylic acid

  acetylsalicylic acid
• Medical condition to be studied:
  Coronary artery disease

Population studied

• Short description of the study population:
  Subject with stable coronary artery disease (CAD) (patients with a history of MI at least one year ago), high risk stable CAD (stable CAD patients with additional risk factors), and PEGASUS-like patients (high risk stable CAD patients with other main PEGASUS inclusion and exclusion criteria) identified from French real world setting for the study period of 2005 to 2012.
• 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:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  5600

Study design details

• Main study objective:
  To assess event rates and cumulative incidence rates of nonfatal MI, nonfatal stroke, major bleeding, and mortality during follow-up, and by specific time periods (follow-up periods 0-1 year, 1-2 years, 2-3 years).
• Outcomes:
  Clinical events during follow-up as well as specific follow-up time periods (0-1 year, 1-2 years, 2-3 years): i) A composite of hospitalisation for non-fatal ACS (primary diagnosis ICD-10 codes I20.0-I21) or non-fatal stroke (ICD-10 codes I63-I64), and all-cause mortality, ii) Each event separately, iii) Hospitalisation for fatal and non-fatal major bleeding (ICD10 codes for bleeding). To describe baseline demographic and clinical characteristics at the time of trigger event and during the year between trigger event and index date.To describe treatment pattern during follow-up, as well as specific time periods (follow-up periods 0-1 year, 1-2 years, 2-3 years).To describe health care resource use and costs during follow-up as well as specific follow-up time periods.
• Data analysis plan:
  Statistical analysis will be carried out by the Bordeaux pharmacoepi according to a documented and approved Statistical Analysis Plan (SAP). The SAP describes statistical analysis as foreseen at the time of planning study. Statistical analysis will be performed after database lock using SAS® software (SAS Institute, last version, North Carolina, USA). Blind double programming will be used for the main outcome measures.Qualitative variables (dichotomous or categorical) will be described in terms of number and frequency. Quantitative variables will be described in terms of mean, standard deviation, median, first and third quartiles, as well as deciles.The Kaplan Meier estimate will be used to estimate the incidence of clinical events. The Cox proportional hazards risk model will be used to assess predictors of the composite clinical events.