LDL Apheresis in Peripheral Arterial Disease

Abstract

Peripheral arterial disease (PAD) is a manifestation of systemic atherosclerosis. Risk factors for PAD are the same as for coronary artery disease, and include age, male gender, cigarette smoking, diabetes mellitus, dyslipidemia and hypertension. Revascularization is technically unsuitable in a large proportion of diabetic patients as well as in patients on chronic hemodialysis due to diffuse and distal obstructions. The combination of macro and microvascular disease with neuropathy leads to the development of diabetic foot ulcers. The LDL apheresis (LA) lowers apolipoprotein B100-containing lipoproteins and other plasma components, such as fibrinogen, thus leading to a functional improvement of both the macro and microcirculation. LA as a treatment option for patients with PAD has been studied in several case series and observational studies, which are here reviewed and discussed. However, as current evidences present some limitations, before any firm conclusion can be drawn, clinical trials with more patients, comparable inclusion criteria, objective endpoints, and extended follow-up periods are needed. “HELP-Apheresis in treatment of diabetic ischemic foot” (HADIF) is a randomized, controlled, prospective trial aimed at assessing the effects of LA in association with traditional therapy in patients with ischemic diabetic foot and peripheral vasculopathy unsuitable for revascularization (ClinicalTrials.gov-Identifiers: NCT01518205). HADIF will explore the hypothesis of whether LA may offer an alternative therapeutic option for these patients threatened to undergo amputation.