A Randomized, Double-Blind Placebo-Controlled Trial Comparing the Effect of Intravenous Ferric Carboxymaltose on Hospitalizations and Mortality in Iron Deficient Subjects Admitted for Acute Heart Failure - AFFIRM-AHF

Jun 08, 2023
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Vifor Pharma
Date Presented:
11/13/2020
Date Published:
04/13/2023
Date Updated:
06/08/2023
Original Posted Date:
11/13/2020
References

Contribution To Literature:

Highlighted text has been updated as of June 8, 2023.

The AFFIRM-AHF trial showed that intravenous ferric carboxymaltose had some benefit among patients admitted with acute heart failure.

Description:

The goal of the trial was to evaluate intravenous ferric carboxymaltose among patients hospitalized for acute heart failure and iron deficiency compared with placebo.

Study Design

  • Randomized
  • Parallel
  • Placebo
  • Double-blind

Patients hospitalized for acute heart failure and iron deficiency were randomized to intravenous ferric carboxymaltose (n = 567) versus placebo (n = 565). Subjects received between 500 and 2000 mg of ferric carboxymaltose (dosing regimen based on weight and hemoglobin level).

  • Total number of enrollees: 1,132
  • Duration of follow-up: 52 weeks
  • Mean patient age: 71 years
  • Percentage female: 44%
  • Percentage with diabetes: 41%

Inclusion criteria:

  • Hospitalization for acute heart failure
  • Clinical stabilization and ready for discharge
  • Serum ferritin <100 ng/ml or serum ferritin 100-299 ng/ml and transferrin saturation <20%
  • Left ventricular ejection fraction (LVEF) <50%

Exclusion criteria:

  • Acute coronary syndrome, transient ischemic attack, or stroke within last 30 days
  • Coronary revascularization or cardiac procedure within 30 days
  • Hemoglobin <8 g/dl or >15 g/dl
  • Active infection requiring antibiotics
  • Intravenous iron or blood transfusion within the last 3 months or oral iron >100 mg/day within the last month

Principal Findings:

The primary outcome, total heart failure hospitalizations and cardiovascular death within 52 weeks, occurred in 52.5% of the ferric carboxymaltose group compared with 67.6% of the placebo group (p = 0.059). Among those with hemoglobin <12 g/dL vs. hemoglobin ≥12 g/dL: p for interaction = 0.15.

Secondary outcomes:

  • Cardiovascular death: 13.8% of the ferric carboxymaltose group compared with 14.2% of the placebo group (p = 0.89)
  • Total heart failure hospitalizations: 48.9% of the ferric carboxymaltose group compared with 53.5% of the placebo group (p = 0.013)

Interpretation:

Among patients with acute heart failure with iron deficiency, intravenous ferric carboxymaltose was associated with a numerical reduction in total heart failure hospitalizations and cardiovascular death irrespective of hemoglobin level. Intravenous ferric carboxymaltose was associated with a significant reduction in total heart failure hospitalizations compared with placebo.

References:

Filippatos G, Ponikowski P, Farmakis D, et al. Association Between Hemoglobin Levels and Efficacy of Intravenous Ferric Carboxymaltose in Patients With Acute Heart Failure and Iron Deficiency: An AFFIRM-AHF Subgroup Analysis. Circulation 2023;147:1640-53.

Ponikowski P, Kirwan BA, Anker SD, et al., on behalf of the AFFIRM-AHF Investigators. Ferric carboxymaltose for iron deficiency at discharge after acute heart failure: a multicentre, double-blind, randomised, controlled trial. Lancet 2020;396:1895-904.

Presented by Dr. Piotr Ponikowski at the American Heart Association Virtual Scientific Sessions, November 13, 2020.

Clinical Topics: Dyslipidemia, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Lipid Metabolism, Acute Heart Failure, Vascular Medicine

Keywords: AHA20, AHA Annual Scientific Sessions, Anemia, Iron-Deficiency, Ferric Compounds, Ferritins, Geriatrics, Heart Failure, Hemoglobins, Maltose, Patient Discharge, Stroke Volume, Ventricular Function, Left


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