Intravenous ferric derisomaltose reduces risk of heart failure: Lancet

A new study published in The Lancet suggests that intravenous ferric derisomaltose administration was linked to lower risk of heart failure hospital admissions and cardiovascular death for a wide range of patients with heart failure, reduced left ventricular ejection fraction, and iron deficiency, supporting the value of iron replenishment in this population.

Intravenous treatment of ferric carboxymaltose improves quality of life and exercise capacity in the near term for patients with heart failure, decreased left ventricular ejection fraction, and iron deficiency, and lowers hospital admissions for heart failure by up to a year. In order to assess the longer-term effects of intravenous ferric derisomaltose on cardiovascular events in patients with heart failure, Paul Kalra and colleagues undertook this study.

70 hospitals in the UK participated in the prospective, open-label, randomized, blinded-endpoint IRONMAN experiment. Patients who were at least 18 years old, had heart failure, and had serum ferritin levels that were less than 100 g/L or a transferrin saturation of less than 20% were eligible. Using a web-based system, participants were arbitrarily allocated (1:1) to receive intravenous ferric derisomaltose or standard care, stratified by recruiting context and trial site. The experiment had an open label and results were judged anonymously. The dosage of intravenous ferric derisomaltose was calculated based on the patient's body weight and hemoglobin level. Recurrent hospital admissions for heart failure and cardiovascular mortality were the major outcomes that were evaluated in all individuals with verified random assignment.

The key findings of this study were:

1. 1869 individuals were assessed for eligibility between August 25, 2016, and October 15, 2021. Of them, 1137 were chosen at random to receive intravenous ferric derisomaltose (n = 569) or standard treatment (n = 568).

2. The median follow-up period was 2 years (IQR: 1 to 6).

3. In the ferric derisomaltose group, there were 336 main endpoints, while there were 411 in the usual care group.

4. In the COVID-19 analysis, the ferric derisomaltose group experienced 210 main endpoints as opposed to 280 in the usual care group. Infection-related hospitalizations or fatalities did not differ across groups.

5. Cardiovascular severe adverse events occurred in 200 (36%) fewer ferric derisomaltose individuals than in the standard care group.

Reference:

Kalra, P. R., Cleland, J. G. F., Petrie, M. C., Thomson, E. A., Kalra, P. A., Squire, I. B., Ahmed, F. Z., Al-Mohammad, A., Cowburn, P. J., Macdougall, I. C., Pellicori, P., Ray, R., Robertson, M., … Stuart, D. (2022). Intravenous ferric derisomaltose in patients with heart failure and iron deficiency in the UK (IRONMAN): an investigator-initiated, prospective, randomised, open-label, blinded-endpoint trial. In The Lancet. Elsevier BV. https://doi.org/10.1016/s0140-6736(22)02083-9