Abstract

Abstract Background The THEMIS randomized controlled trial showed that patients with stable coronary artery disease and type 2 diabetes mellitus (CAD-T2DM), without prior myocardial infarction (MI) or stroke, and who received ticagrelor plus aspirin, had a lower incidence of ischemic cardiovascular events but a higher incidence of major bleeding than those who received placebo plus aspirin. The number of patients concerned and their characteristics in current practice are not well known. Purpose To assess the characteristics of CAD-T2DM adults (≥18 years) without prior MI-stroke, and more specifically, of THEMIS-like patients in a real world setting. Methods Cohort within the main scheme of the SNDS (Système National des Données de Santé), the French nationwide claims database, representing about 86% of 66 million people. All CAD-T2DM prevalent patients without prior MI-stroke were identified on January 1st, 2014 (index date) based on a 5-year database history, and followed for two years. The THEMIS-like population included CAD-T2DM patients without prior MI-stroke ≥50 years at index date without renal failure with dialysis, cirrhosis or liver cancer history, as well as no intracranial and gastro-intestinal bleeding for the last 6 months, or anticoagulant or antiplatelet agent 2 months before and after index date. Study prevalence was standardized for the European population for 1,000 adults (‰) using sex and 5-year age classes from Eurostat statistics. Results From the 359,595 CAD-T2DM patients identified in the database, 71.8% had no prior MI-stroke (n=258,260), including 24.9% of THEMIS-like patients (n=64,334). CAD-T2DM without prior MI-stroke and THEMIS-like patients had the same mean age of 72 years, with 68% and 66% men, 26% and 25% with more than 4-year CAD and T2DM history, 79% and 76% of hypertension, 28% and 19% of revascularisation procedure, 19% and 11% of peripheral arterial disease, 16% and 9% of heart failure, and 39% and 32% of diabetes complications, respectively. The table below presents prevalence estimation per 1,000 European adults with differences according to both populations, as well as sex and age-classes. Conclusions The two populations had similar characteristics, although noting some differences in comorbidities. The THEMIS-like prevalence was estimated to 1.50‰ European adults, representing about a quarter of CAD-T2DM patients without prior MI-stroke. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Study performed with unconditional funding from AstraZeneca

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