In iron-deficient patients with heart failure (HF) and reduced or mildly reduced left ventricular ejection fraction, intravenous ferric carboxymaltose (FCM) was associated with a reduced risk of total cardiovascular hospitalizations and cardiovascular death over 52 weeks, based on a meta-analysis presented at ESC Congress 2023.

Researchers pooled individual participant data from the CONFIRM-HF, AFFIRM-AHF and HEART-FID trials, all of which were randomized, placebo-controlled trials of FCM in adult patients with HF and iron deficiency with at least 52 weeks of follow up. Across the three trials, a total of 4,501 patients with HF and reduced or mildly reduced left ventricular ejection fraction and iron deficiency were randomly assigned to FCM (n=2,251) or placebo (n=2,250). The mean age of the total population was 69 years, 63% were men, and the mean left ventricular ejection fraction was 32%.

The primary efficacy endpoints were a composite of total cardiovascular hospitalizations and cardiovascular death, as well as a composite of total HF hospitalizations and cardiovascular death. Key secondary endpoints included individual components of the composite endpoints.

Findings from the meta-analysis showed FCM therapy significantly reduced the co-primary composite endpoint of total cardiovascular hospitalizations and cardiovascular death compared with placebo. Researchers noted a trend towards reduction of the coprimary composite endpoint of total HF hospitalizations and cardiovascular death, but it failed to reach statistical significance (RR 0.87; 95% CI 0.75 to 1.01; p=0.076).

In other findings, FCM therapy was associated with a 17% relative rate reduction in total cardiovascular hospitalizations and a 16% relative rate reduction in total HF hospitalizations. No effect of FCM administration on mortality was observed. Subgroup analyses found that patients in the lowest transferrin saturation tertile (<15%) experience greater benefit from FCM on the composite endpoint of total cardiovascular hospitalizations or cardiovascular death than those with higher baseline transferrin saturation. Overall, treatment with FCM appeared to be safe and well-tolerated.

"This was the largest and most up-to-date analysis of the effect of FCM in iron-deficient HF patients with reduced or mildly reduced ejection fraction," said Piotr Ponikowski, MD, of Wroclaw Medical University in Poland. "The findings indicate that intravenous FCM should be considered in iron-deficient patients with HF and reduced or mildly reduced ejection fraction to reduce the risk of hospitalization due to HF and cardiovascular causes."

Clinical Topics: Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: ESC Congress, ESC23, ACC International, Heart Failure

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