Underestimation of cardiovascular risk in four European countries: results from the prospective, non-interventional MILOS study

Background Although cardiovascular (CV) disease is the leading cause of death in Europe, many individuals are undertreated due to underestimation of their CV risk, resulting in a high remaining risk. Further real-world data are needed to assess the alignment of risk estimation with European guidelines. Purpose To assess concordance between investigator-assessed and centrally derived CV risk according to the 2019 European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) guidelines for the management of dyslipidaemias through an interim analysis of baseline data from four European countries in the MILOS study. Methods The MILOS study is an ongoing European, prospective, non-interventional study evaluating the effectiveness and safety of bempedoic acid (BA) and the BA + ezetimibe fixed-dose combination. Adult patients with hypercholesterolaemia or mixed dyslipidaemia were recruited from October 2022 to February 2024. Baseline CV risk (low, moderate, high or very high) was classified by the investigator and compared with the CV risk centrally derived according to the 2019 ESC/EAS guidelines in patients in the MILOS study from Austria, Belgium, Italy and the United Kingdom. Results Overall, 2121 patients from Austria (n=200), Belgium (n=375), Italy (n=1310) and the United Kingdom (n=236) were analysed. Across the four countries, there were large differences in CV risk estimation in clinical practice compared with centrally derived risk in both high- and very high-risk patients (Figure 1). According to central derivation, high CV risk was underestimated by the investigator in 28–48% of patients and very high CV risk was underestimated in 16–67% of patients (Figure 2). Conclusions Data from four European countries in the MILOS study reveal that patients’ actual CV risk is often underestimated in clinical practice. Across the four countries, underestimation of risk ranges from three to five of every 10 high-risk patients, and from two to seven out of every 10 very high-risk patients. Therefore, strategies are needed to understand why CV risk estimation is not being implemented correctly based on recommendations in European guidelines. This will help to ensure that patients receive appropriate treatment based on a formal CV risk assessment rather than perceived CV risk.