Ferric carboxymaltose infusion offers little help in iron-deficient patients with heart failure

Intravenous ferric carboxymaltose does not appear to be beneficial in terms of heart failure (HF) hospitalization and cardiovascular mortality in patients with HF and iron deficiency, according to a study.

The study included 1,105 patients (mean age 70 years, 33 percent female) enrolled at 70 sites across six European countries. The inclusion criteria were left ventricular ejection fraction of ≤45 percent and serum ferritin level <100 ng/mL or between 100 and 299 ng/mL if transferrin saturation was <20 percent.

The patients were randomly assigned to receive ferric carboxymaltose (n=558), initially administered at an intravenous dose of up to 2,000 mg then followed by 500 mg every 4 months (unless stopping criteria were met), or a saline placebo (n=547).

Time to cardiovascular death or first HF hospitalization was the first primary outcome, total HF hospitalizations was the second primary outcome, and time to cardiovascular death or first HF hospitalization in patients with transferrin saturation <20 percent was the third primary outcome.

Over a median follow-up of 16.6 months, the first primary outcome occurred in fewer patients in the ferric carboxymaltose group vs the placebo group (141 vs 166 patients; hazard ratio [HR], 0.79, 95 percent confidence interval [CI], 0.63–0.99; p=0.04), but the difference did not meet statistical significance.

On the other hand, the incidence of the second primary outcome did not significantly differ between the ferric carboxymaltose and placebo groups (264 vs 320 times; rate ratio, 0.80, 95 percent CI, 0.60-1.06; p=0.12). The same was true for the third primary outcome (103 vs 128 patients; HR, 0.79, 95 percent CI, 0.61–1.02; p=0.07).

A similar number of patients had at least one serious adverse event in the ferric carboxymaltose and placebo groups (48.2 percent vs 49.9 percent; p=0.61).