IV iron does not reduce time to hospitalization, death for adults with HF, iron deficiency

ByErin T. Welsh, MA

Fact checked byRichard Smith

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Key takeaways:

IV ferric carboxymaltose did not reduce time to first HF hospitalization or CV death vs. placebo for adults with HF and iron deficiency.
Results were similar for those with transferrin saturation less than 20%.

CHICAGO — Ferric carboxymaltose, an IV iron replacement therapy, did not reduce the time to first HF hospitalization or CV death for patients with HF and iron deficiency, according to results of a late-breaking clinical trial.

“The results of the FAIR-HF2 trial are promising and in line with previous results, but by themselves, they are not significant in a strict statistical sense,” Stefan D. Anker, MD, PhD, heart failure cardiologist at Charité Berlin, said during the presentation at the American College of Cardiology Scientific Session.

Anker and colleagues conducted a multicenter, randomized clinical trial with data from 1,105 patients with HF and iron deficiency (mean age, 70 years; 33% women) from 70 clinic sites in six European countries from March 2017 to November 2023. All patients were randomly assigned to ferric carboxymaltose (n = 558) administered at up to 2,000 mg followed by 50 mg intravenously every 4 months or saline placebo intravenously (n = 547).

Primary outcomes were time to CV mortality or first HF hospitalization, total HF hospitalizations and time to CV mortality or first HF hospitalization for those with a transferrin saturation less than 20%.

After a median follow-up period of 16.6 months, 141 patients in the intervention group and 166 in the placebo group experienced first HF hospitalization or CV mortality (HR = 0.79; 95% CI, 0.63-0.99). Total HF hospitalizations occurred 264 times in the intervention group and 320 times in the placebo group (RR = 0.8; 95% CI, 0.6-1.06). In addition, CV mortality or first HF hospitalization for patients with a transferrin saturation of less than 20% occurred in 103 patients in the intervention group and 128 in the placebo group (HR = 0.79; 95% CI, 0.61-1.02).

Researchers observed a similar percentage of patients with at least one serious adverse event in the intervention and placebo groups (48.2% and 49.9%, respectively).

“We need to better understand how to give intravenous iron in the long term,” Anker said. “In the first year, we gave on average 2,000 mg to 2,500 mg and we did a good job. In the second and third year, it is my personal opinion, we are giving too little. We need to do more research in this field and then, of course, also in the HF with preserved ejection fraction field.”

Reference:

Anker SD, et al. JAMA. 2025;doi:10.1001/jama.2025.3833.

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Sources/Disclosures

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Source:

Anker SD, et al. FAIR-HF-W: Ferric carboxymaltose assessment of morbidity and mortality in patients with iron deficiency and chronic heart failure. Presented at: American College of Cardiology Scientific Session; March 29-31, 2025; Chicago (hybrid meeting).

Disclosures: Anker reports receiving grants from Abbott and received personal fees from Actimed Therapeutics, Alleviant, AstraZeneca, Bayer, Berlin Heals, BioVentrix, Boehringer Ingelheim, Brahms, Cardiac Dimensions, Cardior Pharmaceuticals GmbH, Cordio, CSL Vifor, CVRx, Cytokinetics, Edwards Lifesciences, Farraday Pharmaceuticals, GlaxoSmithKline, HeartKinetics, Impulse Dynamics, Lilly, Mankind Pharma, Medtronic, Novartis, Novo Nordisk, Occlutech, Pfizer, Regeneron, Relaxera, Repairon GmbH, SCIRENT Clinical Research and Science, Sensible Medical, Servier, Vectorious Medical Technologies, Vivus and V-Wave.