University of Oulu

Ray, K. K., Haq, I., Bilitou, A., Aguiar, C., Arca, M., Connolly, D. L., Eriksson, M., Ferrières, J., Hildebrandt, P., Laufs, U., Mostaza, J. M., Nanchen, D., Rietzschel, E., Strandberg, T., Toplak, H., Visseren, F. L. J., & Catapano, A. L. (2021). Evaluation of contemporary treatment of high- and very high-risk patients for the prevention of cardiovascular events in Europe – Methodology and rationale for the multinational observational SANTORINI study. In Atherosclerosis Plus. 43, 24–30.

Evaluation of contemporary treatment of high- and very high-risk patients for the prevention of cardiovascular events in Europe : methodology and rationale for the multinational observational SANTORINI study

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Author: Ray, Kausik K.1; Haq, Inaam2; Bilitou, Aikaterini2;
Organizations: 1Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London, UK
2Daiichi Sankyo Europe, Munich, Germany
3Heart Institute, Carnaxide, Portugal
4Department of Translational and Precision Medicine, Sapienza Università di Roma, Rome, Italy
5Sandwell and West Birmingham NHS Trust, Birmingham City Hospital, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, UK
6Karolinska University Hospital, Stockholm, Sweden
7Department of Cardiology and INSERM UMR 1295, Toulouse Rangueil University Hospital, Toulouse University School of Medicine, Toulouse, France
8Frederiksberg Heart Clinic, Frederiksberg, Denmark
9University Hospital Leipzig, Leipzig, Germany
10La Paz-Carlos III Hospital, Madrid, Spain
11Center for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne, Switzerland
12Ghent University and Ghent University Hospital, Ghent, Belgium
13University of Helsinki and Helsinki University Hospital, Helsinki, Finland
14University of Oulu, Center for Life Course Health Research, Oulu, Finland
15Department of Medicine, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria
16Department of Vascular Medicine, University Medical Center Utrecht, Utrecht, the Netherlands
17Department of Pharmacological and Biomolecular Sciences, University of Milan and Multimedica IRCCS, Milan, Italy
Format: article
Version: published version
Access: open
Online Access: PDF Full Text (PDF, 0.4 MB)
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Language: English
Published: Elsevier, 2021
Publish Date: 2021-12-17


Background and aims: Clinical practice before 2019 suggests a substantial proportion of high and very high CV risk patients taking lipid-lowering therapy (LLT) would not achieve the new LDL-C goals recommended in the 2019 ESC/EAS guidelines (<70 and <55 mg/dL, respectively). To what extent practice has changed since the last ESC/EAS guideline update is uncertain, and quantification of remaining implementation gaps may inform health policy.

Methods: The SANTORINI study is a multinational, multicentre, prospective, observational, non-interventional study documenting patient data at baseline (enrolment) and at 12-month follow-up. The study recruited 9606 patients ≥18 years of age with high and very high CV risk (as assigned by the investigators) requiring LLT, with no formal patient or comparator groups. The primary objective is to document, in the real-world setting, the effectiveness of current treatment modalities in managing plasma levels of LDL-C in high- and very high-risk patients requiring LLT. Key secondary effectiveness objectives include documenting the relationship between LLT and levels of other plasma lipids, high-sensitivity C-reactive protein (hsCRP) and overall predicted CV risk over one year. Health economics and patient-relevant parameters will also be assessed.

Conclusions: The SANTORINI study, which commenced after the 2019 ESC/EAS guidelines were published, is ideally placed to provide important contemporary insights into the evolving management of LLT in Europe and highlight factors contributing to the low levels of LDL-C goal achievement among high and very high CV risk patients. It is hoped the findings will help enhance patient management and reduce the burden of ASCVD in Europe.

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Series: Atherosclerosis plus
ISSN: 2667-0909
ISSN-E: 2667-0895
ISSN-L: 2667-0909
Volume: 43
Pages: 24 - 30
DOI: 10.1016/j.athplu.2021.08.003
Type of Publication: A1 Journal article – refereed
Field of Science: 3121 General medicine, internal medicine and other clinical medicine
Funding: This study is funded by Daiichi Sankyo Europe GmbH, Munich, Germany, who defined the study design, data collection and analysis. Six contract research organizations were contracted to conduct the study in 14 countries on behalf of Daiichi Sankyo Europe. Kausik Ray acknowledges support from the National Institute of Health Research Imperial Biomedical Research Centre. Alberico L. Catapano acknowledges support from the Italian Ministry of Health – Ricerca Corrente – IRCCS MultiMedica.
Copyright information: © 2021 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY license (