Physicians' Academy for Cardiovascular Education

High-dose IV iron decreases occurrence of first and recurrent HF events in patients on hemodialysis

Heart Failure Hospitalization in Adults Receiving Hemodialysis and the Effect of Intravenous Iron Therapy

Literature - Jhund PS, Petrie MC, Robertson M et al. - JACC Heart Fail. 2021 Jul;9(7):518-527. doi: 10.1016/j.jchf.2021.04.005.

Introduction and methods

Patients with CKD are at high risk of developing HF [1,2]. To date, no treatment has been shown to reduce HF events in hemodialysis patients. The current analysis of the PIVOTAL trial assessed the effect of IV iron therapy either administered proactively in a high-dose regimen or administered reactively in a low-dose regimen on HF events in adults receiving hemodialysis.

The PIVOTAL trial [3,4] enrolled adults with end-stage kidney disease receiving maintenance hemodialysis for no more than 12 months. Included patients had ferritin<400 µg/L, TSAT <30% and were receiving erythropoiesis stimulating agents (ESAs). Existing iron therapy was stopped and ferritin concentration and TSAT were measured monthly. A total of 2141 patients were randomized (1:1) to receive either high-dose IV iron administered proactively (a monthly dose of 400 mg of iron sucrose. Safety cutoff limits were ferritin >700 µg/L or TSAT >40%) or low-dose IV iron administered reactively (0 to 400 mg of iron sucrose monthly, to maintain ferritin ≥200 µg/L and TSAT ≥20%). The primary composite outcome of the PIVOTAL trial was MI, stroke, HF hospitalization or all-cause death. HF hospitalization was an adjudicated outcome, component of the primary composite outcome and prespecified secondary outcome of the trial. The current analysis focused on the following outcomes: first HF hospitalization or HF death (i.e. first fatal or nonfatal HF event), first HF hospitalization or CV death, and total (first and recurrent) HF events. Median follow-up was 2.1 years.

Main results


Treatment with high-dose IV iron administered proactively, compared to low-dose IV iron administered reactively, decreased the occurrence of first and recurrent HF events in adults receiving hemodialysis.


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Find this article online at JACC Heart Fail.

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