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 studyResearch in context

• Main Authors: Kausik K. Ray (Author), Inaam Haq (Author), Aikaterini Bilitou (Author), Marius C. Manu (Author), Annie Burden (Author), Carlos Aguiar (Author), Marcello Arca (Author), Derek L. Connolly (Author), Mats Eriksson (Author), Jean Ferrières (Author), Ulrich Laufs (Author), Jose M. Mostaza (Author), David Nanchen (Author), Ernst Rietzschel (Author), Timo Strandberg (Author), Hermann Toplak (Author), Frank L.J. Visseren (Author), Alberico L. Catapano (Author)
• Format: Book
• Published: Elsevier, 2023-06-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.
• Notes: 2666-7762; 10.1016/j.lanepe.2023.100624
• Keywords: Cardiovascular disease; LDL cholesterol; High cardiovascular risk; Lipid-lowering therapy; Real-world evidence; Cohort study; Public aspects of medicine; RA1-1270
• Source: The Lancet Regional Health. Europe, Vol 29, Iss , Pp 100624- (2023)

Summary: Background: European data pre-2019 suggest statin monotherapy is the most common approach to lipid management for preventing cardiovascular (CV) events, resulting in only one-fifth of high- and very high-risk patients achieving the 2019 ESC/EAS recommended low-density lipoprotein cholesterol (LDL-C) goals. Whether the treatment landscape has evolved, or gaps persist remains of interest. Methods: Baseline data are presented from SANTORINI, an observational, prospective study that documents the use of lipid-lowering therapies (LLTs) in patients ≥18 years at high or very high CV risk between 2020 and 2021 across primary and secondary care settings in 14 European countries. Findings: Of 9602 enrolled patients, 9044 with complete data were included (mean age: 65.3 ± 10.9 years; 72.6% male). Physicians reported using 2019 ESC/EAS guidelines as a basis for CV risk classification in 52.0% (4706/9044) of patients (overall: high risk 29.2%; very high risk 70.8%). However, centrally re-assessed CV risk based on 2019 ESC/EAS guidelines suggested 6.5% (308/4706) and 91.0% (4284/4706) were high- and very high-risk patients, respectively. Overall, 21.8% of patients had no documented LLTs, 54.2% were receiving monotherapy and 24.0% combination LLT. Median (interquartile range [IQR]) LDL-C was 2.1 (1.6, 3.0) mmol/L (82 [60, 117] mg/dL), with 20.1% of patients achieving risk-based LDL-C goals as per the 2019 ESC/EAS guidelines. Interpretation: At the time of study enrolment, 80% of high- and very high-risk patients failed to achieve 2019 ESC/EAS guidelines LDL-C goals. Contributory factors may include CV risk underestimation and underutilization of combination therapies. Further efforts are needed to achieve current guideline-recommended LDL-C goals. Trial registration: ClinicalTrials.gov Identifier: NCT04271280. Funding: This study is funded by Daiichi Sankyo Europe GmbH, Munich, Germany.