The Iron (Fe) and Atherosclerosis Study (FeAST): A pilot study of reduction of body iron stores in atherosclerotic peripheral vascular disease

Background levels of body iron stores, represented by the serum ferritin co ncentration, rise with age after adolescence men and menopause in women. Th is rise has been implicated mechanistically and epidemiologically in the pa thogenesis:of atherosclerosis through iron-induced oxygen free radical-medi ated lipid oxidation, However, the precise contribution of iron stores to a therosclerosis and its complications are unknown because prospective random ized trials designed to test effects of reduction of iron stores on clinica l outcomes in this disease have not been performed. Methods and Results In preparation for a prospective randomized trial, a ra ndomized pilot study was conducted to evaluate the feasibility, safely, and methodologic accuracy of calibrated reduction in iron stores by phlebotomy in a cohort of patients with advanced peripheral vascular disease. Phlebot omy resulted in a significant reduction in serum ferritin concentration to near targeted levels. Thus the formula for calculating the volume of blood to be removed to achieve a predetermined decrement in serum ferritin concen tration was accurate and phlebotomy was not associated with any adverse lab oratory or clinical effects. Conclusions Reduction of body iron stores to a predetermined level is feasi ble and can be achieved in a timely manner with excellent patient complianc e. Prospective randomized trials of calibrated reduction of body iron store s may be undertaken to define their pathophysiologic significance in athero sclerosis and other diseases in which excessive iron-induced oxidative stre ss has been implicated.