Physicians' Academy for Cardiovascular Education

Lower risk of HF hospitalizations with ferric carboxymaltose in patients with iron deficiency, stabilized after acute HF

Ferric carboxymaltose for iron deficiency at discharge after acute heart failure: a multicentre, double-blind, randomised, controlled trial

Literature - Ponikowski P, Kirwan BA, Anker SD, et al. - Lancet 2020;396:1895-1904. doi: 10.1016/S0140-6736(20)32339-4. Epub 2020 Nov 13.

Introduction and methods

Iron deficiency in patients with acute heart failure is common and associated with poor prognosis [1-5], regardless of anemia. Two randomized clinical trials (FAIR-HF and CONFIRM-HF) have shown that intravenous (IV) ferric carboxymaltose (FCM) improved symptoms, exercise tolerance, and quality of life in iron deficient patients with HFrEF [6,7]. And a meta-analysis reported that FCM therapy was associated with decreased total HF hospitalizations and CV deaths in these patients[8]. However, the effect of FCM treatment on outcomes of CV death or HF hospitalization in patients with iron deficiency who were admitted to hospital for acute HF has not prospectively been investigated.

This study assessed the effect of IV FCM or placebo on morbidity and mortality in patients with iron deficiency after hospitalization for acute HF.

The AFFIRM-AHF was a multicenter, randomized, double-blind, placebo-controlled trial that included patients hospitalized with acute HF, LVEF<50% and iron deficiency between March 21, 2017 and July 30, 2019. Iron deficiency was defined as serum ferritin < 100 ng/mL or 100-299 ng/mL with transferrin saturation levels <20%. Patients (n=1132) were randomized (1:1) to receive FCM or placebo shortly before discharge from the hospital. The second dose was administrated at week 6. Subsequent doses of study treatment were given to patients with persistent iron deficiency at weeks 12 and 24. Efficacy and safety outcomes were assessed at week 4, 12, 36, and 52. Primary outcome was a composite of total HF hospitalizations and CV death up to 52 weeks after randomization. Secondary outcomes included the composite of total CV hospitalization and CV death, total HF hospitalizations, CV death, total CV hospitalization, time to first HF hospitalization or CV death, and days lost because of HF hospitalization or CV death. Follow-up was 52 weeks.

Main results


Patients with iron deficiency hospitalized for acute HF, who were treated with IV FCM were less frequently hospitalized for HF compared to those receiving placebo. FCM treatment had no effect on CV death.


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