Background:
Based on the ESC/EAS 2019 guidelines, the DGK recommends treatment goals for LDL-cholesterol according to cardiovascular (CV) risk stratification. Multiple real-world studies in Europe have demonstrated suboptimal achievement of the older and less ambitious 2016 LDL-C goals, with combination therapy with ezetimibe or PCSK9-inhibitors used in 9% and 1% of patients, respectively. SANTORINI is the first European observational study since the 2019 guidelines to assess whether management of high- and very high-risk patients has improved.

Purpose:
To describe patient characteristics and treatment patterns of lipid lowering treatment (LLT) in real-world practice for the management of LDL-C levels in high- and very high-risk patients in Germany.

Methods:
Patients were recruited from 14 European countries across primary and secondary care settings, with patient characteristics, medical history, current LLT and other co-medications documented at baseline. Inclusion criteria were age ≥18 years with high and very high CV risk requiring LLT. Risk was defined per local practice, e.g. using the Systematic Coronary Risk Estimation (SCORE) system, for which ESC/EAS guidelines classify high-risk and very high-risk as a calculated 10-year risk of fatal CV disease of ≥5–<10% and ≥10%, respectively.

Results:
Of 9606 patients recruited from March 2020 to February 2021 in Europe, cleaned data on 2086 patients from Germany were available in July 2021. In this interim report, mean (SD) age was 65.7 (10.9) years and 28.0% were female. Most of the investigators were specialists in Cardiology (71.5%). The majority of patients were classified as very high risk (72.3%), with 27.6% high risk. ESC/EAS guidelines were the most common basis for risk classification (53.3%), then clinical experience (39.3%) and national guidelines (4.5%). Concomitant CV risk factors included being a current or former smoker (16.5% and 39.4%, respectively), hypertension (83.6%), diabetes (33.1%) and familial hypercholesterolemia (10.3%).

Mean LDL-C was 2.58 (1.21) mmol/L [100.5 (47.1) mg/dl]. Very high risk patients had a lower LDL-C than high risk patients (2.45 (1.16) mmol/L [95.4 (45.2) mg/dl] vs. 2.93 (1.29) mmol/L [114.1 (50.2) mg/dl]).

At baseline, 20.6% of patients were not receiving any LLT. 59.4% of patients were receiving LLT monotherapy, including 56.2% on statins, 1.6% ezetimibe, 1.5% a PCSK9i, and 0.1% other oral LLT. Combination therapy was used in 19,9% of patients, including 16.5% receiving statin plus ezetimibe, 2.2% PCSK9i plus oral LLT, and 1.2% any other oral combination therapy.

Conclusions:
This study in patients at high and very high CV risk shows, although the ESC/EAS guidelines are the most frequently used basis for risk classification, LDL-C levels remain substantially higher than recommended goals. Combination therapies are only prescribed in a minority of patients and PCSK9 inhibitors are very rarely used.