Specific Lp(a) Apheresis for Regression of Coronary and Carotid Atherosclerosis

A 72-week, Prospective, Parallel-group, Partially Blinded, Controlled Phase IIIb Study Evaluating the Impact of Specific Lp(a) Apheresis on Atherosclerotic Disease Burden in Coronary Heart Disease Patients With High Lipoprotein(a) Level.

To evaluate whether specific lipoprotein(a) apheresis on the top of optimal medical therapy could affect atherosclerotic disease burden in coronary and carotid arteries of coronary heart disease patients with elevated Lp(a) levels.

Following the hypothesis that if Lp(a) excess has a pathogenic role in atherogenesis, then specific elimination of circulating Lp(a) should affect plaque growth and stability, we evaluated the efficacy of Lp(a) apheresis on changes in coronary plaque volume and composition and carotid intima-media thickness in patients with CHD on the background of optimal medical treatment.

Inclusion Criteria:

• Stable coronary heart disease (CHD) requiring a clinically indicated coronary angiography.
• Lp(a) ≥50 mg/dL
• LDL-C <2.6 mmol/L (100 mg/dL)
• Signed written informed consent form to participate in the study

Exclusion Criteria:

• history of acute coronary syndrome or surgical intervention within prior 3 months to inclusion
• chronic infectious and inflammatory diseases
• familial hypercholesterolemia
• TG ≥4.5 mmol/L (400 mg/dL)
• Active liver disease (ALT or AST >3 upper limit of normal (ULN), or total bilirubin >1.5 ULN);
• CK ≥3 ULN;
• Thyroid dysfunction;
• Renal dysfunction (creatinine clearance (Cockcroft-Gault Equation) ≤30 ml/min);
• Uncontrolled diabetes (HbA1c ≥7.0%);
• Coagulopathies;
• Lipid-lowering drugs, except statins for the last month
• Known statin or immunoadsorption intolerance