Comparison of LDL-C target achievement and Lp(a) assessment in patients with atherosclerotic cardiovascular disease in differing treatment specialties in Germany: Rationale and design of LipidSnapshot

Rationale:  Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of death in Germany accounting for 33% of deaths in 2021. Elevated low density lipoprotein cholesterol (LDL-C) levels and elevated lipoprotein(a) (Lp(a)) are major risk factors that can independently contribute to the development of ASCVD. Office-based cardiologists (OBCs) and general practitioners (GPs) are main specialties for treatment of patients (pts) with hypercholesterolemia in Germany. However, differing guidelines for the treatment of those pts are available. On the one hand, the Nationale Versorgungsleitlinie (NVL) mentions the “fire and forget” strategy as well as the “treat to target” strategy with a LDL-C value of 70 mg/dL as target for hypercholesterolemia treatment. Testing of Lp(a) is not advised in the NVL. On the other hand, the German Cardiac Society (DGK), which advises German cardiologists’ diagnosis and treatment decisions, recognized the 2019 European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) guidelines for the management of dyslipidemia, with a LDL-C treatment target defined as a LDL-C reduction of ≥50% from baseline and a LDL-C treatment goal of <55 mg/dL (<1.4 mmol/L) in ASCVD pts. Additionally, the guideline endorses the measurement of Lp(a) to be considered at least once in a lifetime to identify those with very high inherited Lp(a) levels >180 mg/dL (>430 nmol/L). LipidSnapshot aims to compare LDL-C target achievement and Lp(a) assessment in ASCVD pts in differing treatment specialties in Germany. 

Study Design: LipidSnapshot is a research project consisting of two parts. Part 1 is a prospective, non-interventional multicenter research project. Data from 1500 adults with known coronary artery disease, peripheral artery disease, prior myocardial infarction or ischemic stroke are collected from 49 OBCs. Part 2 is a retrospective, aggregated analysis of anonymous electronic medical records of 82,375 outpatient adults with prior myocardial infarction, stroke, or peripheral artery disease or coronary heart disease diagnosis documented by GPs obtained from the IQVIA Disease Analyzer. The primary objective of LipidSnapshot is to assess the proportion of ASCVD pts documented by OBCs compared to GPs achieving the 2019 ESC/EAS defined LDL-C treatment goal. Secondary objectives are to assess the proportion of ASCVD pts documented by OBCs compared to GPs with a documented Lp(a) value, assess the proportion of ASCVD pts documented by OBCs compared to GPs reaching pre-defined LDL-C goal (LDL-C < 55 mg/dl; < 70 mg/dl; < 100 mg/dl, < 130 mg/dl, < 190 mg/dl, ≥190 mg/dl), to describe differences in lipid lowering therapies in ASCVD pts documented by OBCs compared to GPs, as well as to address gender- and age-related differences in ASCVD pts treated by OBCs compared to GPs. Data collection will be repeated annually for 3 years.

Conclusion: LipidSnapshot is a joint research project of the Center of Health Services Research of the German Cardiac Society (DGK-ZfKVF), Bundesverband niedergelassener Kardiologen (BNK), Deutsche Gesellschaft zur Bekämpfung von Fettstoffwechselstörungen und ihren Folgeerkrankungen DGFF (Lipid-Liga) e.V. and Novartis. It will provide valuable insights into hypercholesterolemia treatment in ASCVD pts in differing treatment specialties in Germany over the course of 3 years. The project can potentially identify gaps in healthcare provision and thereby help to improve cross-sectoral care for pts in Germany.