#2608 IV IRON IN CKD AND HF: IMPROVING CLINICAL OUTCOMES WITH HIGH-DOSE IV IRON IN PATIENTS WITH IRON DEFICIENCY, HEART FAILURE AND CKD

Abstract

Abstract Background and Aims The emerging role of IV iron to reduce cardiovascular risk, particularly risk of hospitalisation for heart failure. Cardiovascular diseases are a common comorbidity in patients with chronic kidney disease. There is emerging evidence that treating with IV iron may not only correct for iron deficiency and anaemia but also have positive effect on hard clinical endpoints. Method The most recent RCT trial published is the IRONMAN trial, which was a prospective, randomised, open-label, blinded-endpoint trial done at 70 hospitals in the UK. 1137 patients with heart failure, a reduced left ventricular ejection fraction and iron deficiency were randomised to receive either ferric derisomaltose (FDI) on top of usual care or usual care alone. A large proportion of the patients (64%) had an eGFR < 60 mL/min/1.73 m2. Results Compared to usual care, FDI was associated with a 18% lower risk of recurrent heart failure hospitalisations and CV death, which approached statistical significance (p = 0.07). In the prespecified COVID-19 sensitivity analysis, the primary endpoint was nominally statistically significant with a relative risk reduction of 24% (p = 0.047). Between Aug 25, 2016, and Oct 15, 2021, 1869 patients were screened for eligibility, of whom 1137 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). Conclusion For a broad range of patients with heart failure, reduced left ventricular ejection fraction and iron deficiency, intravenous ferric derisomaltose administration was associated with a lower risk of hospital admissions for heart failure and cardiovascular death, further supporting the benefit of iron repletion in this population.