Why the study?
The 2019 ESC risk classification for type 2 diabetes was revised in 2021 by excluding individuals with 3 or more additional ASCVD risk factors from the very high-risk category, prompting an assessment of patient distribution and associated all-cause mortality risk under both classifications.
Does the 2021 ESC risk classification better predict all-cause mortality in patients with type 2 diabetes compared to the 2019 classification?
Does the 2021 ESC risk classification better predict all-cause mortality in patients with type 2 diabetes compared to the 2019 classification?
The 2021 ESC risk classification, which downgrades patients with ≥3 ASCVD risk factors to high-risk, is consistent with all-cause mortality data in patients with type 2 diabetes.
Reclassifying patients with ≥3 risk factors but no TOD/ASCVD to high-risk aligns with observed mortality; supports refining ESC categories but needs prospective validation.
Background. Atherosclerotic cardiovascular disease (ASCVD) is the main cause for the excess mortality in type 2 diabetes. In 2019, the European Society of Cardiology (ESC) identified three risk categories, with the very high-risk category including individuals with established ASCVD and/or target organ damage (TOD) and/or ≥ 3 additional ASCVD risk factors. This classification was revised in 2021 manly by excluding the latter group from the very high-risk category. This analysis assessed the distribution according to the two ESC classifications and the associated risk of all-cause mortality in patients with type 2 diabetes from the Renal Insufficiency And Cardiovascular Events Italian Multicentre Study. Methods. This observational, prospective study enrolled 15,773 patients in 19 Diabetes Clinics throughout Italy in 2006–2008. Participants were stratified based on the presence of established ASCVD, TOD (renal ± retinal), and ASCVD risk factors at baseline. Vital status was retrieved on 31 October 2015 for 15,656 patients (99.3%). Results. Less than 1% of participants fell in the moderate-risk category with both classifications; moreover, approximately one third fell in the high-risk and two thirds in the very high-risk category according to the 2019 classification, whereas the opposite was observed with the 2021 classification. Mortality risk (adjusted hazard ratio [95% confidence interval]) was increased in high-risk (2.805 [0.903–8.719], P = 0.075, and 2.757 [1.311–5.795], P = 0.007) and very high-risk (6.529 [2.105–20.254], P = 0.001, and 6.865 [3.266–14.432], P < 0.0001) versus moderate-risk category according to the 2019 and 2021 classification, respectively. Among patients at very high-risk, risk of death 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. Only a few patients with type 2 diabetes fall in the moderate-risk category, suggesting an overestimation of ASCVD risk. Downgrading those with ≥ 3 additional ASCVD risk factors to the high-risk category is consistent with all-cause mortality data. Risk of death is very high in the presence of TOD (namely microangiopathy), possibly due to the association with subclinical ASCVD. Trial registration. ClinicalTrials.gov, NCT00715481, 15 July, 2008.
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Orsi et al. (2022) studied this question.
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