Results of AFFIRM-AHF trial from AHA 2020 detail the effects of intravenous ferric carboxymaltose in patients with acute heart failure and iron deficiency.
Results of the AFFIRM-AHF trial demonstrate use intravenous ferric carboxymaltose (FCM) was associated with reduced risk of hospitalizations and cardiovascular death when administered at discharge in patients with acute heart failure.
Presented at American Heart Association (AHA) Scientific Sessions 2020, data from the randomized clinical trial provide backing for the use of FCM and could bring about changes to current guidelines related to use of intravenous FCM in patients with acute heart failure.
“Iron deficiency is common in patients with heart failure, and it is an independent risk factor for hospital admission and death,” said study presenter Piotr Ponikowski, MD, PhD, head of the department of heart diseases at Wroclaw Medical University in Wroclaw, Poland, in a statement from the AHA. “We tested the hypothesis that correcting iron deficiency with ferric carboxymaltose in patients admitted for an episode of acute heart failure and who have iron deficiency is effective in reducing the risk of recurrent hospitalization and cardiovascular death.”
With iron deficiency present in about 50% of patients with heart failure, Ponikowski and a team of colleagues sought to determine whether administering intravenous FCM before hospital discharge among patients with heart failure and iron deficiency could reduce recurrent hospitalizations and cardiovascular death over a 52-week study period. Enrolling a population of 1108 patients across 15 countries, the trial was one of the largest to date examining iron replacement therapy as a potential treatment in heart failure patients.
Once enrolled, patients were randomized to receive either FCM or placebo therapy in a 1:1 ratio. After this initial dosing at discharge, patients received treatment with the study drug or placebo at 6, 12, and 24 weeks after discharge based on measurements of iron levels. The primary outcome of the study was a composite of total heart failure hospitalizations and cardiovascular death up to 52 weeks. Secondary outcomes for the study included total heart failure hospitalizations, cardiovascular death, time to first heart failure hospitalization or cardiovascular death, total hospitalizations and cardiovascular death, and days lost due to heart failure hospitalizations or cardiovascular death.
For inclusion in the study, patients were required to be hospitalized for acute heart failure, be iron deficient, have a left ventricular ejection fraction less than 50%, and hemoglobin levels of 8-15 g/dL. The mean age of the study participants was 71 years, 56% were men, and the mean left ventricular ejection fraction was 33%.
Upon analysis, patients in the FCM group had a 21% lower rate of the study’s primary endpoint than those in the placebo group (RR, 0.79; 95% CI, 0.62-1.01; P=.059). Results also suggested FCM was associated with reduction in rate of total heart failure hospitalizations (RR, 0.74; 95% CI, 0.58-0.94; P=.013) and cardiovascular death (HR, 0.96; 95% CI, 0.70-1.32; P=.809).
Due to the ongoing coronavirus disease 2019 (COVID-19) pandemic, investigators had to conduct a COVID-19 sensitivity analysis, which involved censoring patients in each country at the date when its first COVID-19 patients was reported. In this analysis, using FCM was associated with a rate ratio for total HF hospitalizations of 0.75 (95% CI, 0.59-0.96), a rate ratio of 0.70 for total heart failure hospitalizations (95% CI, 0.55-0.90; P=.005), and a hazard ratio of 0.94 (95% CI, 0.68-1.29; P=.69).
For more on the results of AFFIRM-AHF and how this information impacts clinical practice, Practical Cardiology reached out to John McMurray, MD, of the University of Glasgow and trial discussant from AFFIRM-AHF’s presentation at AHA 2020, for further insight.
This study, “Ferric carboxymaltose for iron deficiency at discharge after acute heart failure: a multicentre, double-blind, randomised, controlled trial,” was presented at AHA 2020 and simultaneously published in The Lancet.