Reducing iron stores does not benefit patients with peripheral arterial disease

General

Clinical Question:
Does reducing iron stores improve outcomes for patients with symptomatic peripheral arterial disease?

Bottom Line:
Reducing body iron stores by regular phlebotomy does not reduce the risk of adverse events for patients with symptomatic peripheral arterial disease (PAD). It remains possible, however, that a positive benefit may be seen with longer follow-up than 3.5 years, especially for individuals beginning treatment at a younger age (the mean age was 67 years in this study). (LOE = 1b)

Reference:
Zacharski LR, Chow BK, Howes PS, et al. Reduction of iron stores and cardiovascular outcomes in patients with peripheral arterial disease. A randomized controlled trial. JAMA 2007;297:603-610.  [PMID:17299195]

Study Design:
Randomized controlled trial (single-blinded)

Allocation:
Concealed

Setting:
Outpatient (specialty)

Synopsis:
Excessive accumulation of iron may increase the risk of cardiovascular disease. These investigators enrolled 1277 patients (mean age = 67 years), 99% of whom were men, with symptomatic PAD and an ankle-brachial blood pressure ratio of 0.85 or less. Subjects were required to have a hematocrit level of greater than 35% and a ferritin level of less than 400 ng/mL. Patients randomly received (concealed allocation assignment) phlebotomy at 6-month intervals (iron-reduction group) or usual care. Iron-reduction targeted a trough ferritin level of 25 ng/mL and a peak ferritin level prior to the next phlebotomy of 60 ng/mL. Complete follow-up occurred for 94% of patients for 3.5 years. Individuals assessing outcomes by patient review and medical record review remained blinded to treatment group assignment. Using intention-to-treat analysis, no significant differences were found between the groups for all-cause mortality, nonfatal myocardial infarction, and stroke. The study was 85% powered to detect 5% difference in outcomes.

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