Intravenous ferric carboxymaltose in iron-Deficient chronic heart failure patients with and without anaemia: A subanalysis of the FAIR-HF trial

Gerasimos Filippatos, Dimitrios Farmakis, Josep Comin Colet, Kenneth Dickstein, Thomas F. Lüscher, Ronnie Willenheimer, John Parissis, Giedrius Gaudesius, Claudio Mori, Barbara Von Eisenhart Rothe, Nicola Greenlaw, Ian Ford, Piotr Ponikowski, Stefan D. Anker

Research output: Contribution to journalArticle

Abstract

Aims Therapy 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 results FAIR-HF randomized 459 patients with CHF [NYHA class 2 or 3, LVEF ≤40% (NYHA 2) or ≤45% (NYHA 3)] 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 forPGA and 1.90 vs. 3.39, P = 0.51 for NYHA). Resultswere 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. Conclusions Treatment 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.

Original languageEnglish
Pages (from-to)1267-1276
Number of pages10
JournalEuropean Journal of Heart Failure
Volume15
Issue number11
DOIs
Publication statusPublished - 2013

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Keywords

  • Anaemia
  • Ferric carboxymaltose
  • Heart failure
  • Intravenous iron
  • Iron deficiency

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Filippatos, G., Farmakis, D., Colet, J. C., Dickstein, K., Lüscher, T. F., Willenheimer, R., Parissis, J., Gaudesius, G., Mori, C., Rothe, B. V. E., Greenlaw, N., Ford, I., Ponikowski, P., & Anker, S. D. (2013). Intravenous ferric carboxymaltose in iron-Deficient chronic heart failure patients with and without anaemia: A subanalysis of the FAIR-HF trial. European Journal of Heart Failure, 15(11), 1267-1276. https://doi.org/10.1093/eurjhf/hft099