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

Change in mean carotid intima-media thickness (IMT)

Change from baseline in mean carotid IMT, as measured by duplex ultrasonography of common carotid arteries after 9 and 18 months.

Time frame: From Baseline to Week 36 (9 months) and to Week 72 (18 months)

Numbers of Coronary segments Showing Regression

Clinically relevant regression or progression was defined as a change from baseline to follow up of ≥10% for percent diameter stenosis

Time frame: From baseline to End of study (Week 72)

Number of Carotid Segments showing Regression

Carotid IMT progression criterion for the 18 months of treatment was considered as growth rate of 0.02 mm (0.015 mm/yr). No changes or reduction in carotid IMT ≥ 0,02 mm served as criterion of stabilization and regression of carotid atherosclerosis, respectively.

Time frame: From Baseline to End of study (Week 72)

Change in total atheroma volume (TAV) from baseline to 18 months post-therapy

TAV at baseline - TAV at Week 72 assessed by intravascular ultrasound (IVUS) imaging of a targeted coronary artery

Time frame: From Baseline to Week 72

Change in absolute volumes of plaque components

Mean change in absolute volumes of plaque components: fibrotic, fibrofatty, necrotic core or dense calcium, assessed by radiofrequency intravascular ultrasonographic (IVUS) imaging at baseline and 18 months post-therapy