Majority of patients with high or very high CV risk between 2020-2021 still fail to achieve LDL-c goals
In 2019, the ESC/EAS recommended more stringent LDL-c goals, and a greater use of combination therapies. In the SANTORINI study was investigated whether the treatment landscape has improved since then.
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 studyLiterature - Ray KK, Haq I, Bilitou A, et al.; SANTORINI Study Investigators. - Lancet Reg Health Eur. 2023 Apr 5. doi: 10.1016/j.lanepe.2023.100624.
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.
References
1. Mach F, Baigent C, Catapano AL, et al. 2019 ESC/EAS guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. The task force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS). Eur Heart J. 2020;41:111-88.
2. Ray KK, Molemans B, Schoonen WM, et al. EU-wide cross-sectional observational study of lipid-modifying therapy use in secondary and primary care: the DA VINCI study. Eur J Prev Cardiol. 2021;28:1279-89.
3. Stock JK. DA VINCI study: change in approach to cholesterol management will be needed to reduce the implementation gap between guidelines and clinical practice in Europe. Atherosclerosis. 2020;314:74-6.