Efficacy of intravenous ferric carboxymaltose in patients with acute heart failure and iron deficiency with and without anaemia: a subgroup analysis of AFFIRM-AHF

Abstract

Background: Iron deficiency is associated with increased morbidity and mortality in patients with acute heart failure (HF), even in the absence of anaemia. Purpose: This prespecified subanalysis of the AFFIRM‐AHF trial investigated the effects of ferric carboxymaltose (FCM) on recurrent HF hospitalisations and cardiovascular (CV) mortality in patients with and without anaemia defined as baseline haemoglobin (Hb) <12 g/dL, ≥12 g/dL. Methods: In total, 1108 patients (558 FCM, 550 placebo) were included in the modified intention‐to‐treat AFFIRM‐AHF analysis. The primary outcome was a composite of total HF hospitalisations and CV death, evaluated up to 52 weeks post‐randomisation. Results: Of the 1108 patients, 228 and 329 in the FCM group and 236 and 314 in the placebo group had Hb <12 g/dL and ≥12 g/dL at baseline, respectively. For patients with a baseline Hb ≥12 g/dL, the total number of HF hospitalisations and CV death was 156 and 201 in the FCM and placebo groups, respectively, with a rate ratio (95% confidence interval) of 0.67 (0.48‐0.93; p=0.016). For patients with Hb <12 g/dL, this was 136 and 171 in the FCM and placebo groups, respectively (0.97 [0.66‐1.41; p=0.862]). This treatment effect was consistent for all secondary outcomes in patients in the FCM group vs placebo, for both Hb subgroups (Figure). Conclusion: Iron deficiency treatment with FCM following acute HF reduced the risk of HF hospitalisations and CV death, irrespective of Hb level at baseline.