Presentation (CTI)

OBJECTIVES: IRONMAN, a prospective, open-label, randomized controlled trial (n=1137) in patients with HF and iron deficiency (ID) demonstrated reduced HF-related hospitalization with IV FDI versus UC. This sub-analysis investigates the effect of treating patients with HF and IDA with FDI versus UC on hospitalization metrics relevant to US healthcare providers and payors.
METHODS: Individual-level data on hospitalization rates were obtained from a subgroup of participants in IRONMAN. These included patients, who at randomization: (i) were anemic as per the World Health Organization definition and (ii) needed ≤1,000 mg of iron based on baseline bodyweight and hemoglobin to align with the US FDA-approved label for FDI. Significance was tested using a Cox proportional hazards model extended to include recurrent events. Parameters evaluated included all hospitalizations, and rehospitalization rates within 30 and 60 days.
RESULTS: The IDA and iron dose criteria were applied to patients enrolled in the UC (n=93) and FDI (n=78) arms of IRONMAN. Overall hospitalization rates were lower with FDI versus UC (1.28 versus 1.48 per person). There were 25 rehospitalizations within 30 days with UC (0.27 rehospitalizations per person) versus 8 with FDI (0.10 per person; p=0.07). Patients in the UC arm experienced 38 rehospitalizations with 60 days (0.41 events per person), versus 21 with FDI (0.27 events per person; p=0.45). Of the rehospitalizations within 60 days, 28 were attributable to CV events in the UC arm versus 13 in the FDI arm (0.30 per person versus 0.17 per person; p=0.32).
CONCLUSIONS: Treating patients with HF and IDA with FDI instead of UC resulted in reductions in the rate of hospitalizations and rehospitalizations per person, aligned with the findings of the broader IRONMAN trial. The findings suggest that the use of IV FDI in patients with HF and IDA could reduce hospital bed occupancy.