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Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Vifor Pharma OnBehalf The AFFIRM-AHF Investigators Introduction AFFIRM-AHF is the first randomised clinical trial to evaluate the effect of intravenous ferric carboxymaltose (IV FCM) (vs placebo) on morbidity and mortality in patients with an episode of acute heart failure (HF) and concomitant iron deficiency. Purpose To determine the effect of FCM versus placebo on efficacy outcomes in the subgroup of the AFFIRM-AHF cohort with a documented history of HF. Methods This subgroup analysis evaluated patients previously diagnosed with HF. Primary outcome was a composite of total HF hospitalisations and CV death. Secondary outcomes included total HF hospitalisations, CV death, time to first HF hospitalisation or CV death, composite of total CV hospitalisations and CV death, and days lost due to HF hospitalisations or CV death. All outcomes were evaluated up to 52 weeks post-randomisation. Results In AFFIRM-AHF, 73% and 70% of patients randomly assigned to FCM and placebo, respectively, had a documented history of HF. Baseline demographics and clinical characteristics were comparable between treatment groups for this subgroup. There were significantly fewer primary events in patients assigned to FCM compared to placebo: 249 vs 336, respectively (rate ratio [RR] 0.72, 95% CI: 0.55–0.95; p = 0.022). 186 total HF hospitalisations occurred in FCM group and 267 in placebo (RR 0.67, 95% CI: 0.52–0.88; p = 0.004). The composite of first HF hospitalisation or CV death occurred in 149 (37%) assigned FCM and in 179 (44%) patients assigned placebo (hazard ratio [HR] 0·76, 95% CI: 0·61–0·95; p = 0·014). Conclusion   In patients with a documented history of HF and iron deficiency who were stabilised after an episode of AHF, treatment with FCM significantly reduced the risk of a composite of total HF hospitalisation and CV death. Primary and Secondary outcomesFCM (n = 405)Placebo (n = 385)RR or HR (95% CI)P valueNo. of eventsRate per 100 patient-yrNo. of eventsRate per 100 patient-yrPrimary outcomeTotal HF hospitalisations and CV death24971.85336101.3RR: 0.72 (0.55-0.95)0.022Secondary outcomesTotal CV hospitalisationsand CV death30888.87401120.57RR: 0.74 (0.58-0.95)0.020Time to CV death63346.5568332.58HR: 0.91 (0.65-1.29)0.602Total HF hospitalisations18653.6726780.28RR: 0.67 (0.52-0.88)0.004Time to first HF hospitalisation or CV death149291.76179257.93HR: 0.76 (0.61-0.95)0.014Days lost due to HF hospitalisation and CV death4.5*526.328.3*955.55RR: 0.58 (0.38-0.90)0.015*Data point is the mean number of days lost per subject.

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