Clinical Research Directory

Inclusion Criteria (intensified treatment group - Evinacumab): 1. Willing and able to provide written informed consent form/assent form for the use of retrospective and prospective data. 2. Male or female patients aged ≥12 years old at time of enrolment (exception for Italy and France ≥18 years). 3. Clinical or genetic diagnosis of Homozygous Familial Hypercholesterolemia (HoFH) according to the consensus statement by Cuchel et al, 2023; EHJ (14). 4. Patients who initiated Evinacumab (at the approved dosage and administration) within 24 months before enrolment as add-on to lipid-lowering treatment (with statins, ezetimibe, PCSK9i and/or other agents or treatment) at stable dose for at least 30 days before Evinacumab initiation, as per routine clinical care and no change in dosing is anticipated. 5. Availability of a baseline CCTA performed at least 6 months prior or 1 month after Evinacumab initiation and a follow-up CCTA performed 18-24 months after Evinacumab initiation. 6. LDL-cholesterol ≥ 140 mg/dl (3.5 mmol/L) despite lipid-lowering treatment. Inclusion criteria (conventional treatment group - No Evinacumab) 1. Willing and able to provide written informed consent form/assent form for the use of retrospective and prospective data. 2. Male or female patients aged ≥12 years old at time of enrolment (exception for Italy and France ≥18 years). 3. Clinical or genetic diagnosis of Homozygous Familial Hypercholesterolemia (HoFH) according to the consensus statement by Cuchel et al, 2023; EHJ (14). 4. Patients with HoFH on standard lipid-lowering therapy (statins, ezetimibe, PCSK9i and/or other agents or treatment) at stable dose for at least 30 days before a baseline CCTA and with a follow-up CCTA after 18-24 months from the baseline one. * Required lipid lowering therapies: statin, ezetimibe and PCSK9 directed therapy (unless discontinuation due to \<15% LDL-cholesterol reduction). * Optional additional lipid-lowering therapies: * Lipoprotein apheresis, at stable intervals for at least 3 months. * Lomitapide, at stable dose for at least 3 months. 5. LDL-cholesterol ≥ 140 mg/dl (3.5 mmol/L) despite lipid-lowering treatment. Exclusion criteria (intensified treatment group - Evinacumab) 1. Patients participating in a clinical trial with an investigational drug within the last 6 months. 2. Patients treated outside of Evinacumab approved indication. 3. Inability to access adequate retrospective clinical data from medical records. 4. Inability or unwillingness to provide informed consent/assent or refusal to participate. 5. Previous multi-vessel coronary artery bypass grafting (CABG). Patients with single-vessel CABG are not excluded. 6. Pregnancy at the time of the LLT administration. 7. Moderate to severe renal impairment, or end-stage renal disease (ESRD) undergoing kidney transplantation or chronic renal replacement therapy. Exclusion criteria (conventional treatment group - No Evinacumab) 1. Participation in any interventional clinical trial involving investigational drugs within the last 6 months. 2. Inability to access adequate retrospective clinical data from medical records. 3. Inability or unwillingness to provide informed consent/assent or refusal to participate. 4. Previous multi-vessel coronary artery bypass grafting (CABG). Patients with single-vessel CABG are not excluded. 5. Moderate to severe renal impairment, or end-stage renal disease (ESRD) undergoing kidney transplantation or chronic renal replacement therapy. 6. Pregnancy at the time of the LLT administration.