IV ferric derisomaltose was associated with a lower risk of hospital admissions for heart failure and cardiovascular death in a broad range of patients with heart failure, reduced left ventricular ejection fraction, and iron deficiency, the IRONMAN investigators report. The findings further support the benefits of iron repletion in this patient population.
Patients aged 18 years or older with heart failure (left ventricular ejection fraction ≤45%) and transferrin saturation less than 20% or serum ferritin less than 100 μg/L at 70 U.K. hospitals were eligible for participation in the open-label IRONMAN trial. Participants were randomized to IV ferric derisomaltose or usual care with masked adjudication of outcomes. Safety and efficacy findings show these results using a primary outcome of recurrent hospital admissions for heart failure and cardiovascular death: “Between Aug 25, 2016, and Oct 15, 2021, 1,869 patients were screened for eligibility, of whom 1,137 were randomly assigned to receive intravenous ferric derisomaltose (n = 569) or usual care (n = 568). Median follow-up was 2.7 years (IQR 1.8–3.6). 336 primary endpoints (22.4 per 100 patient-years) occurred in the ferric derisomaltose group and 411 (27.5 per 100 patient-years) occurred in the usual care group (rate ratio [RR] 0.82 [95% CI 0.66 to 1.02]; P = 0.070). In the COVID-19 analysis, 210 primary endpoints (22.3 per 100 patient-years) occurred in the ferric derisomaltose group compared with 280 (29.3 per 100 patient-years) in the usual care group (RR 0.76 [95% CI 0.58 to 1.00]; P = 0.047). No between-group differences in deaths or hospitalisations due to infections were observed. Fewer patients in the ferric derisomaltose group had cardiac serious adverse events (200 [36%]) than in the usual care group (243 [43%]; difference –7.00% [95% CI –12.69 to –1.32]; P = 0.016).”