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
Contribution To Literature:
The AFFIRM-AHF trial showed that intravenous ferric carboxymaltose had some benefit among patients admitted with acute heart failure.
The goal of the trial was to evaluate intravenous ferric carboxymaltose among patients hospitalized for acute heart failure and iron deficiency compared with placebo.
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%
- 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%
- 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
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).
- 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)
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. Intravenous ferric carboxymaltose was associated with a significant reduction in total heart failure hospitalizations compared with placebo.
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;Nov 13:[Epub ahead of print].
Presented by Dr. Piotr Ponikowski at the American Heart Association Virtual Scientific Sessions, November 13, 2020.
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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