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 the size of the corresponding population in a real-world setting, i.e. CAD-T2DM population without prior MI or stroke, and more specifically, the THEMIS-like population, as well as their risk of major outcomes in current practice.Methods: A 2-year follow-up cohort study included all CAD-T2DM prevalent patients without prior MI or stroke 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 prior MI or stroke and THEMIS-like populations was respectively at 6.17 and 1.53 per 1,000 adults. Both populations had similar general characteristics with the same mean age of 72 years, 68% and 66% men, respectively, and less comorbidities and diabetic complications for the THEMIS-like population. The 2-year cumulative incidence was respectively 1.7% and 1.3% for MI, 1.7% and 1.5% for stroke, 4.8% and 3.1% for major bleeding, 13.6% and 9.7% for all-cause death, and 16.2% and 12.0% for the composite outcome.Conclusion: The THEMIS-like prevalence was estimated to 1.53 per 1,000 adults, representing about a quarter of CAD-T2DM patients without prior MI or stroke. In current French practice, the median age of the THEMIS-like population was 6 years older than in the THEMIS trial (i.e. 72 vs. 66 years), 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 n° EUPAS27402 (http://www.ENCEPP.eu)..
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Preprint| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
ResearchSquare.com - (2022) vom: 29. Juli Zur Gesamtaufnahme - year:2022 |
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| Sprache: |
Englisch |
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| Beteiligte Personen: |
Blin, Patrick [VerfasserIn] |
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| doi: |
10.21203/rs.3.rs-783443/v1 |
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| 520 | |a 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 corresponding population in a real-world setting, i.e. CAD-T2DM population without prior MI or stroke, and more specifically, the THEMIS-like population, as well as their risk of major outcomes in current practice.Methods: A 2-year follow-up cohort study included all CAD-T2DM prevalent patients without prior MI or stroke 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 prior MI or stroke and THEMIS-like populations was respectively at 6.17 and 1.53 per 1,000 adults. Both populations had similar general characteristics with the same mean age of 72 years, 68% and 66% men, respectively, and less comorbidities and diabetic complications for the THEMIS-like population. The 2-year cumulative incidence was respectively 1.7% and 1.3% for MI, 1.7% and 1.5% for stroke, 4.8% and 3.1% for major bleeding, 13.6% and 9.7% for all-cause death, and 16.2% and 12.0% for the composite outcome.Conclusion: The THEMIS-like prevalence was estimated to 1.53 per 1,000 adults, representing about a quarter of CAD-T2DM patients without prior MI or stroke. In current French practice, the median age of the THEMIS-like population was 6 years older than in the THEMIS trial (i.e. 72 vs. 66 years), 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 n° EUPAS27402 (http://www.ENCEPP.eu). | ||
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