The use of intravenous ferric carboxymaltose (FCM) in heart failure patients with iron deficiency reduces the risk of hospitalisation and cardiovascular death, according to research presented at the recent European Society for Cardiology (ESC) Congress 2023 in Amsterdam.
Researchers undertook a meta-analysis of individual participant data from three randomised, placebo-controlled trials of FCM in adult patients with heart failure and iron deficiency: CONFIRM-HF, AFFIRM-HF and HEART-FID.
Across the three trials, a total of 4,501 patients with heart failure 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) for 52 weeks. The mean age of the total population was 69 years, 63% were men and the mean left ventricular ejection fraction was 32%.
Researchers set the primary efficacy endpoints as a composite of total cardiovascular hospitalisations and cardiovascular death, as well as a composite of total heart failure hospitalisations and cardiovascular death. Key secondary endpoints included individual components of the composite endpoints.
FCM therapy and rates of hospitalisation
The trial results revealed FCM therapy significantly reduced the co-primary composite endpoint of total cardiovascular hospitalisations and cardiovascular death compared with the placebo (rate ratio, RR = 0.86, 95% CI 0.75 – 0.98, p = 0.029).
Although there was a trend towards reduction of the co-primary composite endpoint of total heart failure hospitalisations and cardiovascular death, this was not statistically significant (RR = 0.87, 95% CI 0.75 b- 1.02, P = 0.076).
Nevertheless, FCM therapy was associated with a 17% relative rate reduction in total cardiovascular hospitalisations (RR = 0.83, 95% CI 0.73 – 0.96, p = 0.009) and a 16% relative rate reduction in total heart failure hospitalisations (RR = 0.84, 95% CI 0.71 – 0.98 p = 0.025). Despite these benefits, FCM therapy had no effect on mortality.
Professor Piotr Ponikowski, the principal investigator and vice-rector of Wroclaw Medical University, Poland, said: ‘This was the largest and most up-to-date analysis of the effect of FCM in iron-deficient heart failure patients with reduced or mildly reduced ejection fraction.‘
He added: ‘The findings indicate that intravenous FCM should be considered in iron-deficient patients with heart failure and reduced or mildly reduced ejection fraction to reduce the risk of hospitalisation due to heart failure and cardiovascular causes.‘
Heart failure is one of the leading causes of avoidable hospitalisations and iron deficiency is present in over 30% to 50% of patients.
Although iron therapy is known to improve functional capacity, symptoms, and quality of life, until the current meta-analysis, no studies have examined whether treatment impacts on clinical events such as hospitalisation.