Patients with stable coronary artery disease and type 2 diabetes but without prior myocardial infarction or stroke and THEMIS-like patients: real-world prevalence and risk of major outcomes from the SNDS French nationwide claims database

Abstract Aim and hypotheses The THEMIS randomized trial compared ticagrelor plus aspirin versus placebo plus aspirin for patients with stable coronary artery disease and type 2 diabetes mellitus (CAD-T2DM), and without prior myocardial infarction (MI) or stroke. The aim of the study was to quantify...

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Autores principales: Patrick Blin, Patrice Darmon, Patrick Henry, Estelle Guiard, Marie-Agnès Bernard, Caroline Dureau-Pournin, Hélène Maizi, Florence Thomas-Delecourt, Régis Lassalle, Cécile Droz-Perroteau, Nicholas Moore
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spelling oai:doaj.org-article:ad92aa4d41ef458d8ee27316b77cfc3f2021-11-28T12:14:08ZPatients with stable coronary artery disease and type 2 diabetes but without prior myocardial infarction or stroke and THEMIS-like patients: real-world prevalence and risk of major outcomes from the SNDS French nationwide claims database10.1186/s12933-021-01416-11475-2840https://doaj.org/article/ad92aa4d41ef458d8ee27316b77cfc3f2021-11-01T00:00:00Zhttps://doi.org/10.1186/s12933-021-01416-1https://doaj.org/toc/1475-2840Abstract Aim and hypotheses The THEMIS randomized trial compared ticagrelor plus aspirin versus placebo plus aspirin for patients with stable coronary artery disease and type 2 diabetes mellitus (CAD-T2DM), and without prior myocardial infarction (MI) or stroke. The aim of the study was to quantify the size of the CAD-T2DM population without prior MI or stroke population in a real-world setting, and more specifically populations with similar THEMIS selection criteria (THEMIS-like and THEMIS-PCI-like populations), as well as their risk of major outcomes in current practice. Methods A 2-year follow-up cohort study included all CAD-T2DM without MI/stroke prevalent patients on January 1st, 2014 in the SNDS French nationwide claims database. The THEMIS-like population concerned those ≥ 50 years of age with similar THEMIS inclusion and exclusion criteria. Prevalence was standardized to the European population. The cumulative incidence function was used to estimate the incidence of clinical outcomes (MI, ischemic stroke, and major bleeding according to the TIMI classification) with death as competing risk, and the Kaplan–Meier estimate for all-cause death and a composite outcome of MI, stroke and all-cause death. Results From a population of about 50 million adults, the prevalence of CAD-T2DM without MI/stroke, THEMIS-like and THEMIS-PCI-like populations was respectively at 6.04, 1.50 and 0.27 per 1000 adults, with a mean age of 72.7, 72.3 and 70.9 years and less comorbidities and diabetic complications for the THEMIS-like and THEMIS-PCI-like population. The 2-year cumulative incidence was respectively 1.7%, 1.3% and 1.6% for MI, 1.7%, 1.5% and 1.4% for stroke, 4.8%, 3.1% and 2.9% for major bleeding, 13.6%, 9.7% and 6.8% for all-cause death, and 16.2%, 12.0% and 9.5% for the composite outcome. Conclusion THEMIS-like prevalence was estimated at 1.50 per 1,000 adults, representing about a quarter of CAD-T2DM without MI/stroke patients, and 0.27 per 1000 adults for the THEMIS-PCI-like populations. In current French practice, the median age of both these populations was about 5–6 years older than in the THEMIS trial, with a 2-year incidence of major outcomes between two or four time above the ones of the placebo arm of the THEMIS trial using very close definitions. Registration No. EUPAS27402 ( http://www.ENCEPP.eu ).Patrick BlinPatrice DarmonPatrick HenryEstelle GuiardMarie-Agnès BernardCaroline Dureau-PourninHélène MaiziFlorence Thomas-DelecourtRégis LassalleCécile Droz-PerroteauNicholas MooreBMCarticleCoronary artery diseaseType 2 diabetes mellitusPrevalenceMyocardial infarctionStrokeMortalityDiseases of the circulatory (Cardiovascular) systemRC666-701ENCardiovascular Diabetology, Vol 20, Iss 1, Pp 1-11 (2021)
institution DOAJ
collection DOAJ
language EN
topic Coronary artery disease
Type 2 diabetes mellitus
Prevalence
Myocardial infarction
Stroke
Mortality
Diseases of the circulatory (Cardiovascular) system
RC666-701
spellingShingle Coronary artery disease
Type 2 diabetes mellitus
Prevalence
Myocardial infarction
Stroke
Mortality
Diseases of the circulatory (Cardiovascular) system
RC666-701
Patrick Blin
Patrice Darmon
Patrick Henry
Estelle Guiard
Marie-Agnès Bernard
Caroline Dureau-Pournin
Hélène Maizi
Florence Thomas-Delecourt
Régis Lassalle
Cécile Droz-Perroteau
Nicholas Moore
Patients with stable coronary artery disease and type 2 diabetes but without prior myocardial infarction or stroke and THEMIS-like patients: real-world prevalence and risk of major outcomes from the SNDS French nationwide claims database
description Abstract Aim and hypotheses The THEMIS randomized trial compared ticagrelor plus aspirin versus placebo plus aspirin for patients with stable coronary artery disease and type 2 diabetes mellitus (CAD-T2DM), and without prior myocardial infarction (MI) or stroke. The aim of the study was to quantify the size of the CAD-T2DM population without prior MI or stroke population in a real-world setting, and more specifically populations with similar THEMIS selection criteria (THEMIS-like and THEMIS-PCI-like populations), as well as their risk of major outcomes in current practice. Methods A 2-year follow-up cohort study included all CAD-T2DM without MI/stroke prevalent patients on January 1st, 2014 in the SNDS French nationwide claims database. The THEMIS-like population concerned those ≥ 50 years of age with similar THEMIS inclusion and exclusion criteria. Prevalence was standardized to the European population. The cumulative incidence function was used to estimate the incidence of clinical outcomes (MI, ischemic stroke, and major bleeding according to the TIMI classification) with death as competing risk, and the Kaplan–Meier estimate for all-cause death and a composite outcome of MI, stroke and all-cause death. Results From a population of about 50 million adults, the prevalence of CAD-T2DM without MI/stroke, THEMIS-like and THEMIS-PCI-like populations was respectively at 6.04, 1.50 and 0.27 per 1000 adults, with a mean age of 72.7, 72.3 and 70.9 years and less comorbidities and diabetic complications for the THEMIS-like and THEMIS-PCI-like population. The 2-year cumulative incidence was respectively 1.7%, 1.3% and 1.6% for MI, 1.7%, 1.5% and 1.4% for stroke, 4.8%, 3.1% and 2.9% for major bleeding, 13.6%, 9.7% and 6.8% for all-cause death, and 16.2%, 12.0% and 9.5% for the composite outcome. Conclusion THEMIS-like prevalence was estimated at 1.50 per 1,000 adults, representing about a quarter of CAD-T2DM without MI/stroke patients, and 0.27 per 1000 adults for the THEMIS-PCI-like populations. In current French practice, the median age of both these populations was about 5–6 years older than in the THEMIS trial, with a 2-year incidence of major outcomes between two or four time above the ones of the placebo arm of the THEMIS trial using very close definitions. Registration No. EUPAS27402 ( http://www.ENCEPP.eu ).
format article
author Patrick Blin
Patrice Darmon
Patrick Henry
Estelle Guiard
Marie-Agnès Bernard
Caroline Dureau-Pournin
Hélène Maizi
Florence Thomas-Delecourt
Régis Lassalle
Cécile Droz-Perroteau
Nicholas Moore
author_facet Patrick Blin
Patrice Darmon
Patrick Henry
Estelle Guiard
Marie-Agnès Bernard
Caroline Dureau-Pournin
Hélène Maizi
Florence Thomas-Delecourt
Régis Lassalle
Cécile Droz-Perroteau
Nicholas Moore
author_sort Patrick Blin
title Patients with stable coronary artery disease and type 2 diabetes but without prior myocardial infarction or stroke and THEMIS-like patients: real-world prevalence and risk of major outcomes from the SNDS French nationwide claims database
title_short Patients with stable coronary artery disease and type 2 diabetes but without prior myocardial infarction or stroke and THEMIS-like patients: real-world prevalence and risk of major outcomes from the SNDS French nationwide claims database
title_full Patients with stable coronary artery disease and type 2 diabetes but without prior myocardial infarction or stroke and THEMIS-like patients: real-world prevalence and risk of major outcomes from the SNDS French nationwide claims database
title_fullStr Patients with stable coronary artery disease and type 2 diabetes but without prior myocardial infarction or stroke and THEMIS-like patients: real-world prevalence and risk of major outcomes from the SNDS French nationwide claims database
title_full_unstemmed Patients with stable coronary artery disease and type 2 diabetes but without prior myocardial infarction or stroke and THEMIS-like patients: real-world prevalence and risk of major outcomes from the SNDS French nationwide claims database
title_sort patients with stable coronary artery disease and type 2 diabetes but without prior myocardial infarction or stroke and themis-like patients: real-world prevalence and risk of major outcomes from the snds french nationwide claims database
publisher BMC
publishDate 2021
url https://doaj.org/article/ad92aa4d41ef458d8ee27316b77cfc3f
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