The following is a summary of “Ferric Carboxymaltose in Heart Failure with Iron Deficiency,” published in the September 2023 issue of Cardiology by Mentz et al.
Researchers conducted a retrospective analysis to assess whether ferric carboxymaltose, known to benefit symptoms and quality of life in iron-deficient heart failure patients, also impacts critical clinical events.
They conducted a double-blind, randomized trial, assigning ambulatory patients with heart failure, a left ventricular ejection fraction (40%) or less, and iron deficiency (1:1 ratio) to get intravenous ferric carboxymaltose or placebo alongside standard heart failure therapy. Participants got either iron treatment or a dummy, spaced 6 months apart, based on iron markers. The main outcome, a composite of death, heart failure hospitalizations within 12 months, or change in 6-minute walk distance at 6 months, was evaluated with a significance level of 0.01.
The results showed 3,065 patients, with 1,532 in the ferric carboxymaltose group and 1,533 in the placebo group. By month 12, 8.6% in the ferric carboxymaltose group experienced death (131) compared to 10.3% in the placebo group (158); both groups had 297 and 332 hospitalizations for heart failure, respectively. The mean change from baseline to 6 months in the 6-minute walk distance was 8±60 m for ferric carboxymaltose and 4±59 m for placebo (Wilcoxon–Mann–Whitney P=0.02; unmatched win ratio, 1.10; 99% CI, 0.99 to 1.23). Repeated ferric carboxymaltose dosing was safe, with serious adverse events in 27.0% and 26.2% of patients in the ferric carboxymaltose and placebo groups, respectively.
Investigators concluded that iron boost failed to improve key outcomes in heart failure patients with iron deficiency.