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Efficacy of Ferric carboxymaltose in heart failure with iron deficiency: an individual patient data meta-analysis

Institute of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland. Institute of Heart Diseases, University Hospital, Wroclaw, Poland. Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, North Caroline and Duke Clinical Research Institute, Durham, North Carolina, USA. Department of Medicine, Duke University, Durham, North Carolina, USA; Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA. Baylor Scott and White Research Institute, Dallas, Texas, USA; Department of Medicine, University of Mississippi, Jackson, Mississippi, USA. Division of Cardiology, Duke University Medical Center, Durham, North Carolina, USA. Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. CSL Vifor, Glattbrugg, Switzerland. American Regent, Inc., Shirley, New York, USA. University Medical Center Göttingen, Department of Medical Statistics and DZHK (German Center for Cardiovascular Research), partner site Göttingen, Göttingen, Germany. Department of Cardiology (CVK) of German Heart Center Charité; Institute of Health Center for Regenerative Therapies (BCRT), German Centre for Cardiovascular Research (DZHK) partner site Berlin, Charité Universitätsmedizin, Berlin, Germany.

European heart journal. 2023
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PICO Summary

Population

Adults with heart failure (HF) and iron deficiency enrolled in the ferric carboxymaltose (FCM) trials: CONFIRM-HF, AFFIRM-AHF, and HEART-FID (3 randomised controlled trials, n= 4,501).

Intervention

FCM (n= 2,251).

Comparison

Placebo (n= 2,250).

Outcome

The co-primary efficacy endpoints were (1) composite of total/recurrent cardiovascular hospitalizations and cardiovascular death, and (2) composite of total HF hospitalizations and cardiovascular death, through 52 weeks. FCM was associated with a significantly reduced risk of co-primary endpoint 1 (rate ratio [RR] 0.86; 95% confidence interval (CI) [0.75, 0.98]; Cochran Q: 0.008), with a trend towards a reduction of co-primary endpoint 2 (RR 0.87; 95% CI [0.75, 1.01]; Cochran Q: 0.024).
Abstract
BACKGROUND AND AIMS Whereas a beneficial effect of intravenous ferric carboxymaltose (FCM) on symptoms and exercise capacity among patients with iron deficiency (ID) and heart failure (HF) has been consistently demonstrated, the effects of treatment on clinical events remain the subject of research. This meta-analysis aimed to characterize the effects of FCM therapy on hospitalizations and mortality. METHODS Patient-level data from randomized, placebo-controlled FCM trials including adults with HF and ID with ≥52 weeks follow-up were analysed. The co-primary efficacy endpoints were (1) composite of total/recurrent cardiovascular hospitalizations and cardiovascular death, and (2) composite of total HF hospitalizations and cardiovascular death, through 52 weeks. Key secondary endpoints included individual composite endpoint components. Event rates were analysed using a negative binomial model. Treatment-emergent adverse events were also examined. RESULTS Three FCM trials with a total of 4501 patients were included. FCM was associated with a significantly reduced risk of co-primary endpoint 1 (rate ratio [RR] 0.86; 95% confidence interval [CI] 0.75-0.98; P=0.029; Cochran Q: 0.008), with a trend towards a reduction of co-primary endpoint 2 (RR 0.87; 95% CI 0.75-1.01; P=0.076; Cochran Q: 0.024). Treatment effects appeared to result from reduced hospitalization rates, not improved survival. Treatment appeared to have a good safety profile and was well-tolerated. CONCLUSIONS In iron-deficient patients with HF with reduced left ventricular ejection fraction, intravenous FCM was associated with significantly reduced risk of hospital admissions for HF and cardiovascular causes, with no apparent effect on mortality.
Study details
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine