Designing a study to evaluate the effect of apheresis in patients with elevated lipoprotein(a)

Lipoprotein(a) (Lp(a)) is a risk factor for premature coronary artery disease. Lp(a) levels can neither be influenced sufficiently by standard hypolipemic diet nor by drug therapy. Currently, lipid apheresis is the only option to effectively lower Lp(a) levels in patients with elevated Lp(a) and progressive CVD. The lipid-clinic at the Charité University hospital Berlin and other German apheresis centres have longstanding positive experience with this therapeutic regimen. Lately, in Germany lipid apheresis was accepted as the treatment of choice for patients with elevated Lp(a) levels > 60 mg/dl and progressive CVD. At the same time, care providers were obliged to conduct a controlled trial to prove the efficacy of lipid apheresis for this indication. Therefore, we designed a prospective, randomized, controlled trial to prove the hypothesis that lipid apheresis decreases vascular events.