PIVOTAL Trial Summary: Macdougall et al. randomized 2141 adults undergoing maintenance HD to receive either high-dose IV iron sucrose in a proactive fashion (400 mg monthly, unless ferritin >700 μg/l or transferrin saturation ≥40%), or low-dose IV iron, in a reactive fashion (0 to 400mg monthly, with a ferritin<200 μg/l or a transferrin saturation <20% being a trigger for iron administration). The primary objective was to assess if high-dose intravenous iron regimen administered proactively was superior to a low-dose regimen given reactively to patients on maintenance hemodialysis. The primary outcome (composite of nonfatal MI, stroke, hospitalization for HF, or death) was significantly lower in patients receiving high-dose proactive iron therapy. The authors of the PIVOTAL trial concluded that Among patients undergoing hemodialysis, a high-dose intravenous iron regimen administered proactively was superior to a low dose regimen administered reactively and resulted in lower doses of
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