Based on the Iron (Fe) and Atherosclerosis Study (FeAST).ppt

Based on the Iron (Fe) and Atherosclerosis Study (FeAST) FeAST Trial: Background Accumulation of iron in excess of physiologic requirements has been implicated in risk of cardiovascular disease because of increased iron-catalyzed free radical-mediated oxidative stress. The objective of this study was to test the hypothesis that reducing body iron stores through phlebotomy will influence outcomes in a cohort of patients with symptomatic peripheral arterial disease (PAD). FeAST Trial: Primary and Secondary Outcome Events FeAST Trial: Kaplan-Meir Analysis of Primary Endpoint (All-Cause Mortality) FeAST Trial: Kaplan-Meir Analysis of Secondary Endpoint (Death Plus Nonfatal MI, or Stroke) FeAST Trial: Limitations Because of lower than expected accrual, the study was underpowered overall and particularly underpowered to definitively assess outcomes in younger patients and smokers. This study was single-blinded, and primary and secondary endpoints were adjudicated by a committee external to the study; nonetheless, concerns remain about possible bias, particularly in subgroup analyses. FeAST Trial: Limitations (cont.) Patients with very high ferritin levels were excluded from the study, and the efficacy of iron reduction in individuals with extreme levels of iron stores is unknown. FeAST Trial: Summary Preplanned analyses of the primary (all-cause mortality) and the secondary (death plus nonfatal MI and stroke) endpoints performed on the entire study cohort showed no effect of iron reduction. However, there was a significant interaction with age (1of 5 prespecified biological stratifying factors), suggesting that a beneficial effect might exist in younger patients, and observation that coincides with findings of others. FeAST Trial: Summary (cont.) The FeAST data show that it should be possible to test definitively whether controlling iron levels may reduce disease risk and additional research is needed to further define ferrotoxic diseases, stratifying risk reduct