In iron-deficient patients with heart failure and reduced or mildly reduced left ventricular ejection fraction, intravenous ferric carboxymaltose (FCM) is associated with a reduced risk of the composite outcome of total cardiovascular hospitalisation and cardiovascular death through 52 weeks compared with placebo, according to late breaking research presented August, 26 at ESC Congress 2023.
The meta-analysis pooled individual participant data from three randomised, placebo-controlled trials of FCM in adult patients with heart failure and iron deficiency with at least 52 weeks of follow up: CONFIRM-HF, AFFIRM-AHF and HEART-FID.
In 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). The mean age of the total population was 69 years, 63% were men, and the mean left ventricular ejection fraction was 32%.
FCM therapy significantly reduced the co-primary composite endpoint of total cardiovascular hospitalisations and cardiovascular death compared with placebo, with a rate ratio (RR) of 0.86 (95% confidence interval [CI] 0.75 to 0.98; p=0.029). There was a trend towards reduction of the co-primary composite endpoint of total heart failure hospitalisations and cardiovascular death but it failed to reach statistical significance (RR 0.87; 95% CI 0.75 to 1.01; p=0.076).
FCM therapy was associated with a 17% relative rate reduction in total cardiovascular hospitalisations (RR 0.83; 95% CI 0.73 to 0.96; p=0.009) and a 16% relative rate reduction in total heart failure hospitalisations (RR 0.84; 95% CI 0.71 to 0.98; p=0.025). There was no effect of FCM administration on mortality.
In subgroup analyses, patients in the lowest transferrin saturation (TSAT) tertile (<15%) derived greater benefit from FCM on the composite endpoint of total cardiovascular hospitalisations or cardiovascular death than those with higher baseline TSAT (interaction p=0.019).
Treatment with FCM appeared to be safe and well-tolerated.
