A Non-interventional Implementation Study to Evaluate Treatment With Inclisiran (Leqvio®) and Other Lipid Lowering Treatments in a Real-world Setting

Prior treatment

• Oral LLT Cohort: Patients who receive a PCSK9-mAB or other PCSK9-targeted therapy
• Inclisiran Cohort: current or previous PCSK9-targeted treatment
• Patients who have received Inclisiran previously

Other illness

• Any underlying known disease, or surgical, physical, or medical condition that, in the opinion of the investigator (or delegate) might interfere with interpretation of the clinical study results.

Other

• Contraindication for Inclisiran according to the SmPC
• Patients with homozygous FH
• Simultaneous or planned participation in an interventional research study

• Patients who provide written informed consent to participate in the study
• Male or female patients ≥ 18 years of age
• Oral LLT Cohort: Patients with documented ASCVD newly initiated on an oral lipid lowering treatment on top of a statin (e.g. ezetimibe, bempedoic acid, cholestyraimin) or new oral LLT alone in case of statin intolerance or contraindication
• Inclisiran Cohort: Patients newly initiated on Inclisiran fulfilling the restricted reimbursement criteria or individual access requirements who are not at LDL-C goal as per their CV risk as recommended in the 2019 EAS/ESC guidelines (Mach et al., 2020). At least 60% of the documented patients must be PCSK9-inhibitor naive
• Apheresis plus Inclisiran Cohort: Patients with Inclisiran on top of regular weekly or bi-weekly lipoprotein apheresis (LDL-C or LP(a)).