Ferric Carboxymaltose in Iron-Deficient Patients with Hospitalized Heart Failure and Reduced Kidney Function

Department of Renal Medicine, King's College Hospital, London, United Kingdom. Institute of Heart Diseases, Wrocław Medical University, and Institute of Heart Diseases, University Hospital, Borowska 213, 50-556 Wrocław, Poland. Department of Nephrology, University Hospital Limerick and School of Medicine, University of Limerick, Limerick, Ireland. Department of Renal Medicine, University College London, London, United Kingdom. Charité, Campus Virchow-Klinikum, Berlin, Germany. Department of Medicine, Baylor University Medical Center, Dallas, Texas, United States, and Department of Medicine, University of Mississippi Medical Center, Jackson, Mississippi, United States. National and Kapodistrian University of Athens School of Medicine, Athens University, Athens, Greece. CSL Vifor, Glattbrugg, Switzerland. Department of Clinical Research, SOCAR Research SA, Nyon, Switzerland, and London School of Hygiene and Tropical Medicine, University College London, London, United Kingdom. Department of Cardiology, University and Civil Hospital, Brescia, Italy. Centre for Clinical and Basic Research, Department of Medical Sciences, IRCCS San Raffaele Pisana, Rome, Italy. Department of Cardiology, University Heart Center, University Hospital Zürich and University of Zürich, Zürich, Switzerland. University Medical Center Groningen, Department of Cardiology, Groningen, The Netherlands.

Clinical journal of the American Society of Nephrology : CJASN. 2023
BACKGROUND Reduced kidney function is common among patients with heart failure. In patients with heart failure and/or kidney disease, iron deficiency is an independent predictor of adverse outcomes. In the AFFIRM-AHF trial, acute heart failure patients with iron deficiency treated with intravenous ferric carboxymaltose demonstrated reduced risk of heart failure hospitalization, with improved quality of life. We aimed to further characterize the impact of ferric carboxymaltose among patients with coexisting kidney impairment. METHODS The double-blind, placebo-controlled AFFIRM-AHF trial randomized 1132 stabilized adults with acute heart failure (left ventricular ejection fraction <50%) and iron deficiency. Patients on dialysis were excluded. The primary endpoint was a composite of total heart failure hospitalizations and cardiovascular death during the 52-week follow-up period. Additional endpoints included cardiovascular hospitalizations, total heart failure hospitalizations, and days lost to heart failure hospitalizations or cardiovascular death. For this subgroup analysis, patients were stratified according to baseline estimated glomerular filtration rate (eGFR). RESULTS Overall, 60% of patients had an eGFR <60 ml/min/1.73 m 2 (the lower eGFR subgroup). These patients were significantly older, more likely to be female and to have ischemic heart failure, and had higher baseline serum phosphate levels and higher rates of anemia. For all endpoints, event rates were higher in the lower eGFR group. In the lower eGFR group, the annualized event rates for the primary composite outcome were 68.96 and 86.30 per 100 patient-years in the ferric carboxymaltose and placebo arms, respectively (rate ratio, 0.76; 95% confidence interval, 0.54-1.06). The treatment effect was similar in the higher eGFR subgroup (rate ratio, 0.65; 95% confidence interval, 0.42-1.02; Pinteraction =0.60). A similar pattern was observed for all endpoints ( Pinteraction >0.05). CONCLUSIONS In a cohort of patients with acute heart failure, left ventricular ejection fraction <50%, and iron deficiency, the safety and efficacy of ferric carboxymaltose were consistent across a range of eGFR values.
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Language : eng
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