The results of the AFFIRM-AHF trial showed that addressing iron deficiency in patients with heart failure (HF) can lessen the risk of subsequent hospitalizations following an acute HF event. Although the study narrowly missed its primary endpoint, it did demonstrate that intravenous (IV) iron resulted in a significant 26% drop in HF hospitalizations.
Prof. Piotr Ponikowski (Wroclaw Medical University, Poland), reported the findings of the AFFIRM-AHF trial, which were simultaneously published in The Lancet [1,2]. AFFIRM-AHF was a multicentre study of 1,108 patients hospitalized for acute HF. All participants had serum ferritin <100 ng/mL (or 100-299 ng/mL if transferrin saturation <20%). The average age was 71 years, and average ejection fraction was 33%. The combined primary endpoint was total hospitalizations and CV death.
Before being discharged, patients randomly received the first IV treatment of either ferric carboxymaltose or placebo. A second treatment was provided at week 6 to patients with persistent iron deficiency. Ferric carboxymaltose doses were determined by body weight and haemoglobin count (average dose 1,350 mg).
After 52 weeks of follow-up, the combined primary endpoint of total hospitalizations and CV death was not met, although the total number of events was numerically lower in the group treated with ferric carboxymaltose compared with placebo (RR 0.79; 95% CI 0.62-1.01). Because the incidence of CV death was not different between the treatment and placebo groups, the data difference was driven by the significantly reduced risk of HF hospitalizations by 26%.
A treatment benefit was also seen in the secondary endpoint, a time-to-first-event analysis that found a statistically significant reduction in the risk of first HF hospitalization or CV death (HR 0.80; 95% CI 0.66-0.98). Regarding safety, there were no apparent differences between adverse events in the different groups, and IV ferric carboxymaltose was well tolerated.
Prof. Ponikowski concluded by supporting “the recommendation to administer ferric carboxymaltose in patients with iron deficiency, left ventricular ejection fraction below 50%, stabilized after an episode of acute HF, in order to prevent recurrent heart failure hospitalizations.”
- Ponikowski P, et al. AFFIRM-AHF: IV Iron Supplementation Linked to Fewer Repeat Hospitalisations for HF. Abstract LBS.01. Late-Breaking Clinical Science Virtual AHA 2020 Scientific Sessions, 13-17 Nov.
- Ponikowski P, et al. Ferric carboxymaltose for iron deficiency at discharge after acute heart failure: a multicentre, double-blind, randomized, controlled trial. Lancet. 2020;Nov 13.Doi:10.1016/S0140-6736(20)32339-4.