Intravenous ferric carboxymaltose in iron‐deficient chronic heart failure patients with and without anaemia: a subanalysis of the FAIR‐HF trial

Abstract

AimsTherapy with i.v. iron in patients with chronic heart failure (CHF) and iron deficiency (ID) improves symptoms, functional capacity, and quality of life. We sought to investigate whether these beneficial outcomes are independent of anaemia.Methods and resultsFAIR-HF randomized 459 patients with CHF [NYHA class II or III, LVEF ≤40% (NYHA II) or ≤45% (NYHA III)] and ID to i.v. iron as ferric carboxymaltose (FCM) or placebo in a 2:1 ratio. We analysed the efficacy and safety according to the presence or absence of anaemia (haemoglobin ≤120 g/L) at baseline. Of 459 patients, 232 had anaemia at baseline (51%). The effect of FCM on the primary endpoints of self-reported Patient Global Assessment (PGA) and NYHA class at week 24 was similar in patients with and without anaemia [odds ratio (OR) for improvement, 2.48 vs. 2.60, P = 0.97 for PGA and 1.90 vs. 3.39, P = 0.51 for NYHA). Results were also similar for the secondary endpoints, including PGA and NYHA at weeks 4 and 12, 6 min walk test distance, Kansas City Cardiomyopathy Questionnaire overall score, and European Quality of Life-5 Dimensions Visual Analogue Scale at most time points. Regarding safety, no differences were noticed in the rates of death or first hospitalization between FCM and placebo both in anaemic and in non-anaemic patients.ConclusionsTreatment of ID with FCM in patients with CHF is equally efficacious and shows a similar favourable safety profile irrespective of anaemia. Iron status should be assessed in symptomatic CHF patients both with and without anaemia and treatment of ID should be considered.

Modern iron replacement therapy: clinical and pathophysiological insights

“…Such results have been consistently replicated [75,124], so that most recent and authoritative guidelines suggest to systematically check for ID in CHF and IV iron treatment if ID is present [125][126][127]. Noteworthy, a sub-analysis of the seminal FAIR-HF trial [74] focusing on anemic CHF patients showed consistent Hb increase after IV iron, implicitly validating the above mentioned "extensive" criteria for ID [128]. As mentioned above, the beneficial effect of iron in CHF is seen only using IV preparation (for now FCM is the only compound tested in such condition), while a recent trial with oral iron was unsuccessful because of increased hepcidin levels [76].…”

Left ventricular ejection fraction recovery in patients with heart failure treated with intravenous iron: a pilot study

“…During the last decade, ID has become a well‐recognized therapeutic target in HFrEF 1, 2, 11. Two large randomized placebo‐controlled trials have shown that intravenous iron administration was associated to improvement in symptoms, functional capacity, quality of life, and reduction in HF hospitalizations 1, 2.…”

Single‐dose intravenous iron in Southeast Asian heart failure patients: A pilot randomized placebo‐controlled study (PRACTICE‐ASIA‐HF)

“…Results from these trials have established i.v. FCM as a feasible option in the management of HF in patients with concurrent ID irrespective of anaemia status, receiving a Class IIa recommendation in the 2016 European Society of Cardiology guidelines for the treatment of HF 10, 11. Most recently, the Effect of Ferric Carboxymaltose on Exercise Capacity in Patients with Iron Deficiency and Chronic Heart Failure (EFFECT‐HF) trial reinforced the results of these landmark trials by demonstrating significant benefit with i.v.…”