Risk of all-cause mortality according to the European Society of Cardiology risk categories in individuals with type 2 diabetes: the Renal Insufficiency And Cardiovascular Events (RIACE) Italian Multicenter Study

Emanuela Orsi, Anna Solini, Enzo Bonora, Martina Vitale, Monia Garofolo, Cecilia Fondelli, Roberto Trevisan, Monica Vedovato, Franco Cavalot, Luigi Laviola, Susanna Morano, Giuseppe Pugliese, Renal Insufficiency And Cardiovascular Events (RIACE) Study Group, Emanuela Orsi, Anna Solini, Enzo Bonora, Martina Vitale, Monia Garofolo, Cecilia Fondelli, Roberto Trevisan, Monica Vedovato, Franco Cavalot, Luigi Laviola, Susanna Morano, Giuseppe Pugliese, Renal Insufficiency And Cardiovascular Events (RIACE) Study Group

Abstract

Aims: The 2019 and 2021 European Society of Cardiology (ESC) classifications stratified patients with type 2 diabetes into three categories according to the 10-year risk of death from atherosclerotic cardiovascular disease (ASCVD). The very high-risk category included individuals with established ASCVD, target organ damage (TOD), and/or, in the 2019 classification only, ≥ 3 additional ASCVD risk factors. We assessed risk of all-cause mortality according to the two ESC classifications in the Renal Insufficiency And Cardiovascular Events cohort.

Methods: Participants (n = 15,773) were stratified based on the presence of ASCVD, TOD, and ASCVD risk factors at baseline (2006-2008). Vital status was retrieved in 2015.

Results: Less than 1% of participants fell in the moderate-risk category. According to the 2019 classification, ~ 1/3 fell in the high-risk and ~ 2/3 in the very high-risk category, whereas the opposite occurred with the 2021 classification. Mortality risk increased across categories according to both classifications. Among very high-risk patients, mortality was much lower in those with ≥ 3 additional ASCVD risk factors and almost equal in those with TOD and ASCVD ± TOD, using the 2019 classification, whereas it was much higher in those with ASCVD + TOD and, to a lesser extent, TOD only than in those with ASCVD only, using the 2021 classification.

Conclusions: The negligible number of moderate-risk patients suggests that these classifications might overestimate risk of ASCVD death. Downgrading patients with ≥ 3 additional ASCVD risk factors to the high-risk category is consistent with mortality data. Risk of death is very high in the presence of TOD irrespective of established ASCVD.

Trial registration: ClinicalTrials.gov, NCT00715481.

Keywords: All-cause mortality; Atherosclerotic cardiovascular disease; Atherosclerotic cardiovascular disease risk factors; Target organ damage; Type 2 diabetes.

Conflict of interest statement

EO: consultant fees from Eli Lilly and Novo Nordisk, and lecture fees from Astellas. AS: consultant fees from Axxam, Bayer, and Novo Nordisk, and lecture fees from Eli Lilly, Novo Nordisk, and Sanofi-Aventis. EB: consultant fees from Abbott, Bayer, Becton Dickinson, Boehringer Ingelheim, Daiichi-Sankyo, Eli Lilly, and Novo Nordisk. MVi: lecture fees from MundiPharma and Novo Nordisk. MG: consultant fees from Eli Lilly, and lecture fees from Eli Lilly, Merck Sharp & Dohme, and Novo Nordisk. CF: lecture fees from Abbot, Boehringer Ingelheim, Daiichi Sankyo, Eli Lilly, Merck Sharp & Dohme, Mundipharma, and Theras Lifetech. RT: consultant fees from AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, Merck Sharp & Dohme, Novo Nordisk, and Sanofi-Aventis, and lecture fees from AstraZeneca, Boehringer Ingelheim, Eli Lilly, and Novo Nordisk. MVe: lecture fees from Lifescan and Novo Nordisk. FC: consultant fees from Boehringer Ingelheim, and lecture fees from AstraZeneca. LL: consultant fees from Abbott, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Medtronic, MOVI, Novo Nordisk, Roche, Sanofi-Aventis, and Terumo, and lecture fees from Abbott, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Medtronic, Menarini, Merck Sharp & Dohme, MOVI, Mundipharma, Novo Nordisk, Roche, Sanofi-Aventis, and Terumo. SM: none. GPu: consultant fees from Abbot, Bayer, and Novo Nordisk, and lecture fees from AstraZeneca, Boehringer Ingelheim, Eli Lilly, and Novo Nordisk.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Survival analysis by 2019 and 2021 ESC risk categories. Cumulative survival by Kaplan–Meier analysis according to 2019 and 2021 ESC risk categories (A) and subcategories (B). Numbers (percentages) of deaths and HRs (95% CI) are shown for each group. *Reference category. ESC = European Society of Cardiology; RFs = risk factors; TOD = target organ damage; ASCVD = atherosclerotic cardiovascular disease

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