IV Iron Reduces Risk of Rehospitalization Among Iron-Deficient Patients With HF

November 27, 2020
Gianna Melillo

Gianna is an associate editor of The American Journal of Managed Care® (AJMC®). She has been working on AJMC® since 2019 and has a BA in philosophy and journalism & professional writing from The College of New Jersey.

Intravenous (IV) iron reduced rehospitalization risk among patients hospitalized with acute heart failure (HF) and low iron, according to research presented at the American Heart Association’s Scientific Sessions 2020.

Intravenous (IV) iron reduced rehospitalization risk among patients hospitalized with acute heart failure (HF) and low iron, according to research presented at the American Heart Association’s Scientific Sessions 2020.

In patients with HF, iron deficiency (ID) is common and is associated with reduced exercise capacity, poor quality of life, and increased risk of hospitalization and death. However, IV ferric carboxymaltose (FCM) has been shown to improve physical performance and quality of life in stable patients with HF.

To test if IV FCM administered to patients with iron deficiency admitted for acute HF is superior to placebo, researchers conducted a multicenter, randomized (1:1) double-blind trial. The AFFIRM-AHF trial included 1108 patients from 121 centers across 15 countries. Average participant age was 71 years, and the majority (56%) were male. The cohort had an average ejection fraction of 33%.

ID was defined as serum ferritin less than 100 ng/mL, or serum ferritin 100 to 299 ng/mL and transferrin saturation (TSAT) less than 20%. Participants received between 500 and 2000 mg of FCM or placebo during the repletion phase, or up to postdischarge week 6. Dosing regimens were based on weight and hemoglobin level. At weeks 12 and/or 24, during the maintenance phase, patients received 500 mg of FCM or placebo only if ID persisted.

The study’s primary end point was a composite of recurrent HF hospitalizations and cardiovascular death up to 52 weeks after randomization. Secondary end points included total HF hospitalizations, cardiovascular death, time to first HF or cardiovascular death, and days lost due to HF hospitalizations or CV death.

Overall, 558 patients received IV FCM and 550 received placebo. Those who received FCM had significantly fewer hospital readmissions due to HF compared with those who received the placebo.

Analyses revealed:

  • 293 primary events (57.2 per 100 patient-years) occurred in the FCM group and 372 (72.5 per 100 patient-years) occurred in the placebo group (rate ratio [RR], 0.79; 95% CI, 0.62-1.01; P = .059).
  • 370 total cardiovascular hospitalizations and cardiovascular deaths occurred in the FCM group and 451 occurred in the placebo group (RR, 0.80; 95% CI, 0.64-1.00; P = .050).
  • There was no difference in cardiovascular death between the 2 groups (77 [14%] of 558 in the FCM group vs 78 [14%] in the placebo group; HR, 0.96; 95% CI, 0.70-1.32; P = .81).
  • 217 total HF hospitalizations occurred in the FCM group and 294 occurred in the placebo group (RR, 0.74; 95% CI, 0.58-0.94; P = .013).
  • The composite of first HF hospitalization or cardiovascular death occurred in 181 (32%) patients in the FCM group and 209 (38%) in the placebo group (HR, 0.80; 95% CI, 0.66-0.98; P = .030).
  • Fewer days were lost due to HF hospitalizations and cardiovascular death for patients assigned to the treatment compared with placebo (369 days per 100 patient-years vs 548 days per 100 patient-years; RR, 0.67; 95% CI, 0.47-0.97; P = .035).

When it comes to safety, 45% of patients in the treatment group experienced serious adverse events compared with 52% of those in the placebo group. The most common adverse events reported included cardiac disorders, infections, diarrhea and constipation. The study found no apparent effect on the risk of cardiovascular death.

“This is the first study demonstrating the benefits of iron supplementation initiated in stabilized patients hospitalized for acute [HF], and only two doses were needed in the vast majority of patients,” said Piotr Ponikowski, MD, the study’s lead author.

“Health care professionals should screen patients with [HF] for the presence of [ID], and [IV] iron should be considered for those with [ID] and ejection fraction of 50% or lower.”

Reference

Ponikowski P, Kirwan B, Anker SD, et al. Ferric carboxymaltose for iron deficiency at discharge after acute heart failure: a multicenter, double-blind, randomized, controlled trial. Lancet. Published online November 13, 2020. doi:10.1016/S0140-6736(20)32339-4