Study type

Study topic

Disease /health condition

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

Medical condition to be studied

Type 2 diabetes mellitus
Coronary artery disease
Population studied

Short description of the study population

All T2DM and CAD patients without MI or stroke history, identified and followed in the SNDS nationwide claims database.

Three populations were defined:
- CAD-T2DM population: all patients with T2DM diagnosis on 01/01/2014 plus CAD history and affiliated to the main healthcare insurance scheme (CNAMTS), because of incomplete history for other schemes included after 2011;
- CAD-T2DM population without prior MI-stroke: patients of the CAD-T2DM population without diagnosis of MI or stroke during the history period;
- THEMIS-like population: patients of the CAD-T2DM population without prior MI-stroke fulfilling the following criteria:
• Aged ≥ 50 years at index date;
• Without intracranial bleeding before index date;
• Without gastro-intestinal (GI) bleeding within 6 months before index date;
• Without renal failure requiring dialysis;
• Without cirrhosis of liver or liver cancer before index date;
• Without antiplatelet agent (APA) or anticoagulant treatments within 2 months before and after index date.
Exclusion criteria:
All subjects from all populations with the following criteria were excluded:
- Patients < 18 years at index date;
- Patients dead at index date;
- Patients not affiliated to the general scheme (Régime Général) between 2008 and 2016;
- Patients with less than 5 years of history period or incomplete follow-up (without death).

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

Other

Special population of interest, other

Type 2 diabetes mellitus, Coronary artery disease patients

Estimated number of subjects

550000
Study design details

Main study objective

The main objective is to estimate the prevalence of CAD-T2DM without prior MI or stroke in France, as well as of the population with inclusion and exclusion criteria of the THEMIS randomized controlled trial (THEMIS-like population).

Outcomes

MI, ischemic or unknown stroke, CV death, composite CV events (MI, stroke, CV death), all-cause death, heart failure, major organ specific bleeding as intracranial haemorrhage, other critical organ or site bleeding (intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular), other bleeding (GI, urogenital and other bleeding) with transfusion, fatal bleeding.

Data analysis plan

Following analyses will be performed for CAD-T2DM without MI or stroke population and THEMIS-like population:- Description of patients (Flow-Chart, demographic, clinical and therapeutic characteristics at inclusion and during the follow-up)- Description of healthcare resources use and costs during the 2-year follow-up period according to the collective and national health insurance perspectives- Prevalence estimate of each population on 01/01/2013 and 31/12/2014 among French population, overall and according to age and gender- Cumulative incidence estimate of outcomes (stroke, MI, CV death, all-cause death, heart failure, bleeding, composite CV events of MI, stroke, CV death) using Kaplan-Meier estimator and Cumulative Incidence Function to take into account death as a competing risk, overall and according to 3 age-classes (<65, 65-75, >75)- Predictors estimate of the composite CV events using a multivariable Cox proportional hazards regression model with a stepwise method