144 Effect of intravenous ferric derisomaltose in women compared to men with heart failure in the ironman randomised trial

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Background In health, women have a lower haemoglobin than men and their prevalence of both anaemia and iron deficiency may be higher, especially if they have heart failure. The erythropoietic response to iron might also differ between the sexes. We used data from a randomised trial (IRONMAN) of intravenous (IV) ferric derisomaltose (FDI) to investigate these issues. Methods Patients with a diagnosis of heart failure, a left ventricular ejection fraction ≤45%, and either a TSAT <20% or serum ferritin <100 µg/L were included. Haemoglobin for women had to be in the range of 9-13 g/dL and for men 9-14g/dL. Patients were randomised to receive IV ferric derisomaltose (FDI) or not. Neither the patient nor investigator was blinded. The main endpoints of interest were changes in haemoglobin at 4 months and 12 months and the primary endpoint of the trial (the rate of the composite outcome of heart failure hospitalisations or cardiovascular death expressed as events per 100 patient-years). Analyses were conducted by intention to treat, stratified by sex. A further analysis was conducted for patients with a TSAT <20%. Results Of 1,137 patients randomised, 300 were women. Women and men were of similar age (73 vs 74 years), predominantly in NYHA class II, with similar values for NT-proBNP, LVEF, eGFR, ferritin and TSAT. However, haemoglobin was lower in women (11.8 [11.0 to 12.4] g/dL] compared to men (12.3 [11.3 to 13.0] g/dL). The increases in haemoglobin with FDI compared to control was similar for women at 4 months (+0.8 [+0.5 to +1.2] g/dL) and 12 months (+0.8 [+0.4 to +1.3] g/dL) compared to men ((+0.5 [+0.3 to +0.7] g/dL) and (+0.5 [+0.3 to +0.8] g/dL) respectively. The hazard ratio for the primary endpoint for men was 0.81 (0.63 to 1.03) and for women 0.77 (0.42 to 1.42), the wider confidence intervals reflecting the smaller population and fewer events. The results were similar when restricted to patients with a TSAT <20%. Conclusions The increase in haemoglobin with IV FDI and its effect on the primary endpoint rate are similar for men and women. Conflict of Interest None

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