Majority of patients with high or very high CV risk between 2020-2021 still fail to achieve LDL-c goals
Treatment gaps in the implementation of LDL cholesterol control among high- and very high-risk patients in Europe between 2020 and 2021: the multinational observational SANTORINI study
Introduction and methods
Background
In the 2019 update from the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS) guidelines for lipid management, more stringent LDL-c goals are recommended [1]. For patients at high CV risk, it is now recommended to reduce LDL-c levels by ≥50% and aim for LDL-c levels <1.8 mmol/L, while for patients at very high CV risk a reduction ≥50% and a target value <1.4 mmol/L are recommended. The European DA VINCI study, with pre-2019 data, showed that statin monotherapy was the most common approach (84%), while only 10% of patients received combination therapy [2]. This approach resulted in 55% of patients achieving the 2016 ESC/EAS lipid goals, and only 1 in 5 patients at high or very high CV risk achieving the more stringent 2019 ESC/EAS lipid goals [2-3]. However, it is unclear if and how the treatment landscape has evolved since then.
Aim of the study
The aim of this study was to investigate how physicians assess CV risk, which lipid-lowering therapies are used in patients at high or very high CV risk, and to what extent these treatments result in attainment of the 2019 ESC/EAS lipid goals.
Methods
The researchers conducted the SANTORINI (Treatment of High and Very High riSk Dyslipidemic pAtients for the PreveNTion of CardiOvasculaR Events) study, a prospective cohort study of lipid-lowering therapies used in 14 European countries. During 2020-2021, 9044 adult patients (mean age: 65.3 years; 73% male) at high or very high ASCVD risk and a life expectancy of more than one year for whom lipid-lowering therapy would likely be beneficial, were recruited from primary and secondary care. Baseline data were collected from medical records for all dyslipidemia-related doctor’s visits from date of diagnosis.
Outcomes
The researchers were interested in: (a) how physicians assess CV risk; (b) which lipid-lowering therapies are used by patients at high or very high CV risk; and (c) to what extent these treatments result in attainment of the 2019 ESC/EAS LDL-c goals.
Main results
Risk classification
- As reported by physicians, 2637 (29%) patients were classified as high CV risk and 6401 (71%) patients as very high CV risk; CV risk was missing for 6 patients.
- In 4706 (52%) patients, the 2019 ESC/EAS guidelines were cited by the physician as the basis for CV risk classification, of whom 916 (19%) patients were at high and 3790 (81%) patients were at very high CV risk. However, when the CV risk of these patients was reassessed centrally based on the 2019 ESC/EAS guidelines, a higher proportion of patients were classified as very high-risk patients (308 (7%) and 4284 (91%) patients were deemed as high- and very high-risk patients, respectively; CV risk was missing for 114 patients).
Lipid-lowering therapies and LDL-c goal attainment
- Approximately 1 in 5 (22%) patients did not receive lipid-lowering therapy at baseline.
- Overall, 54% of patients received monotherapy, mainly with a statin (50%). Monotherapy was more often used in the high-risk group (58%) than in the very high-risk group (53%).
- Combination therapy was used in 24% of patients, mainly in the form of a statin combined with ezetimibe (16%). Combination therapy was less often used in the high-risk group (18%) than in the very high-risk group (26%).
- The majority (73%) of patients did not achieve the 2019 ESC/EAS LDL-c goals, with median LDL-c levels being 2.1 mmol/L (IQR: 1.6-3.0). 20% of patients were at LDL-c goal, whereas data of 7% of patients were lacking.
Conclusion
This prospective cohort study, conducted in Central and Western Europe, showed that in the vast majority (73%) of patients at high or very high CV risk, the 2019 ESC/EAS target value for LDL-c is not achieved. Inadequate risk classification and the low (24%) use of combination therapy may contribute to this.
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