The Impact of Ferric Derisomaltose on Cardiovascular and Noncardiovascular Events in Patients With Anemia, Iron De ficiency, and Heart Failure With Reduced Ejection Fraction

Background: In some countries, intravenous ferric derisomaltose (FDI) is only licensed for treating iron de fi ciency with anemia. Accordingly, we investigated the effects of intravenous FDI in a subgroup of patients with anemia in the IRONMAN (Effectiveness of Intravenous (IV) Iron Treatment Versus Standard Care in Patients With Heart Failure and Iron De fi ciency) trial. Method and Results: IRONMAN enrolled patients with heart failure, a left ventricular ejection fraction of < 45%, and iron de fi ciency (ferritin < 100 m g/L or transferrin saturation of < 20%), 771 (68%) of whom had anemia (hemoglobin < 12 g/dL for women and < 13 g/dL for men). Patients were randomized, open label, to FDI ( n = 397) or usual care ( n = 374) and followed for a median of 2.6 years. The primary end point, recurrent hospitalization for heart failure and cardiovascular death, occurred less frequently for those assigned to FDI (rate ratio 0.78, 95% con fi dence interval 0.61-1.01; P = .063). First event analysis for cardiovascular death or hospitalization for heart failure, less affected by the coronavirus disease 2019 pandemic, gave similar results (hazard ratio 0.77, 95% con fi dence interval 0.62-0.96; P = .022). Patients randomized to FDI reported a better Minnesota Living with Heart Failure quality of life, for overall ( P = .013) and physical domain ( P = .00093) scores at 4 months. Conclusions: In patients with iron de fi ciency anemia and heart failure with reduced left ventricular ejection fraction, intravenous FDI improves quality of life and may decrease cardiovascular events.