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

Kausik K Ray; Inaam Haq; Aikaterini Bilitou; Marius C Manu; Annie Burden; Carlos Aguiar; Marcello Arca; Derek L Connolly; Mats Eriksson; Jean Ferrières; Ulrich Laufs; Jose M Mostaza; David Nanchen; Ernst Rietzschel; Timo Strandberg; Hermann Toplak; Frank L J Visseren; Alberico L Catapano; SANTORINI Study Investigators

doi:10.1016/j.lanepe.2023.100624

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

Lancet Reg Health Eur. 2023 Apr 5:29:100624. doi: 10.1016/j.lanepe.2023.100624. eCollection 2023 Jun.

Authors

Kausik K Ray¹, Inaam Haq², Aikaterini Bilitou³, Marius C Manu², Annie Burden⁴, Carlos Aguiar⁵, Marcello Arca⁶, Derek L Connolly⁷, Mats Eriksson⁸, Jean Ferrières⁹, Ulrich Laufs¹⁰, Jose M Mostaza¹¹, David Nanchen¹², Ernst Rietzschel¹³, Timo Strandberg^{14

15}, Hermann Toplak¹⁶, Frank L J Visseren¹⁷, Alberico L Catapano^{18

19}; SANTORINI Study Investigators

Affiliations

¹ Imperial Centre for Cardiovascular Disease Prevention, ICTU-Global, Imperial College London, London, UK.
² Medical Affairs, Daiichi Sankyo Europe, Munich, Germany.
³ Health Economics and Outcomes Research, Daiichi Sankyo Europe, Munich, Germany.
⁴ Biostatistics and Data Management, Daiichi Sankyo Europe, Munich, Germany.
⁵ Advanced Heart Failure and Heart Transplantation Unit, Heart Institute, Carnaxide, Portugal.
⁶ Department of Translational and Precision Medicine, Sapienza Università di Roma, Rome, Italy.
⁷ Sandwell and West Birmingham NHS Trust, Birmingham City Hospital, Institute of Cardiovascular Sciences, University of Birmingham, and Aston Medical School, Birmingham, UK.
⁸ Department of Medicine, Karolinska University Hospital, Stockholm, Sweden.
⁹ Department of Cardiology and INSERM UMR 1295, Toulouse Rangueil University Hospital, Toulouse University School of Medicine, Toulouse, France.
¹⁰ Department of Cardiology, University Hospital Leipzig, Leipzig, Germany.
¹¹ Department of Internal Medicine, La Paz-Carlos III Hospital, Madrid, Spain.
¹² Center for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne, Switzerland.
¹³ Department of Internal Medicine and Pediatrics, Ghent University and Ghent University Hospital, Ghent, Belgium.
¹⁴ Department of Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
¹⁵ Center for Life Course Health Research, University of Oulu, Oulu, Finland.
¹⁶ Division of Endocrinology and Diabetology, Department of Medicine, Medical University of Graz, Graz, Austria.
¹⁷ Department of Vascular Medicine, University Medical Center Utrecht, Utrecht, the Netherlands.
¹⁸ Department of Pharmacological and Biomolecular Sciences, University of Milan, Milan, Italy.
¹⁹ Multimedica IRCCS, Milan, Italy.

Abstract

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.

Keywords: Cardiovascular disease; Cohort study; High cardiovascular risk; LDL cholesterol; Lipid-lowering therapy; Real-world evidence.

Associated data

ClinicalTrials.gov/NCT04271280