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The Impact of Ferric Derisomaltose on Cardiovascular and Noncardiovascular Events in Patients With Anemia, Iron Deficiency, and Heart Failure With Reduced Ejection Fraction

2023; Elsevier BV; Volume: 30; Issue: 5 Linguagem: Inglês

10.1016/j.cardfail.2023.10.006

1532-8414

Robin Ray, Ian Ford, John G.F. Cleland, Fraser J Graham, Fozia Ahmed, Abdallah Al‐Mohammad, Peter J. Cowburn, Chris Critoph, Philip A. Kalra, Rebecca Lane, Andrew Ludman, Pierpaolo Pellicori, Mark C. Petrie, Michelle M. Robertson, Alison Seed, Iain Squire, Paul R. Kalra, Paul R. Kalra, Elena Cowan, Serena Howe, Charlotte Turner, Rosalynn Austin, Rebeca Lane, Paula Rogers, Paul Foley, Badri Chandrasekaran, Eva Fraile, Lynsey Kyeremeh, Fozia Ahmed, Mark Petrie, Lorraine McGregor, Joanna Osmanska, Fraser J Graham, Ninian N. Lang, Bernhard Meyer, Faheem Ahmad, Joanna Osmanska, Iain Squire, Jude Fisher, Philip A. Kalra, Christina Summersgill, Katarzyna Adeniji, Rajkumar Chinnadurai, Andrew Ludman, Lisa Massimo, Clare S. Hardman, Daisy Sykes, Peter J. Cowburn, Sarah Frank, Simon Smith, Alan G. Japp, Mohamed Anwar, Beth Whittington, Alison Seed, Robin Ray, Vennessa Sookhoo, Abdallah Al‐Mohammad, Janet Middle, Kay Housley, Andrew L. Clark, Jeanne Bulemfu, Christopher Critoph, Victor Chong, Stephen J. Wood, Benjamin R. Szwejkowski, Chim C. Lang, Jackie Duff, Susan M. MacDonald, Rebekah Schiff, John Donnelly, Thuraia Nageh, Swapna Kunhunny, Mark Petrie, Roy S. Gardner, Marion McAdam, Elizabeth McPherson, Prithwish Banerjee, Eleanor Sear, Nigel Edwards, Jason Glover, Pierpaolo Pellicori, Clare Murphy, Justin Cooke, Charles Spencer, Mark L. Francis, Iain Matthews, Hayley McKie, Andrew Marshall, Janet Large, Jenny Stratford, Piers Clifford, Sara Tavares, Christopher J. Boos, Philip J. Keeling, Debbie Hughes, Aaron Wong, Deborah J. Jones, Alex James, Rhys Williams, Stephen J Leslie, Jim Finlayson, Piers Clifford, Andrew Hannah, Philip Campbell, John Walsh, Jane Quinn, Callum Chapman, Susan Piper, Preeti Gupta, Victor Sim, Lucy Knibbs, Kristopher Lyons, Lana Dixon, Colin J. Petrie, Yuk-ki Wong, Catherine Labinjoh, Simon Duckett, Ian J. Massey, Henry Oluwasefunmi Savage, Sofia Matias, Jonaifah Ramirez, Charlotte Manisty, Ifza Hussain, Rajiv Sankaranarayanan, Gershan Davis, Samuel McClure, John Baxter, Eleanor Wicks, Jolanta Sobolewska, Jerry D. Murphy, Ahmed Elzayat, Alastair Cooke, Jay Wright, Simon G. Williams, Amal Muthumala, Parminder S Chaggar, Geraint Ellis, Mandie Welch, Sudantha Bulugahapitiya, Thomas Jackson, Tapesh Pakrashi, Ameet Bakhai, Reto Gamma, Susan Ellery, Charlotte Manisty, Geraint H. Jenkins, Angus K. Nightingale, Elizabeth Thomson, Ian Ford, Michele Robertson, Nicola Greenlaw, Kirsty Wetherall, Ross Clarke, Fraser J Graham, Sharon Kean, A. C. Stevenson, Robbie S. Wilson, Sarah C. Boyle, John B. McHugh, Lisa Hall, Joanne Woollard, Claire Brunton, Eleanor Dinnett, Amanda Reid, Jill Nicholls, Anna Cunnington, Serena Howe, Elizabeth Douglas, Margaret Fegen, Marc V. Jones, Sheila McGowan, Barbara Ross, Pamela Sandu, Pamela Surtees, Debra Stuart,

Hemoglobinopathies and Related Disorders

BackgroundIn some countries, intravenous (IV) ferric derisomaltose (FDI) is only licensed for treating iron deficiency with anemia. Accordingly, we investigated the effects of intravenous FDI in a subgroup of patients with anemia in the IRONMAN trial.Method and ResultsIRONMAN enrolled patients with heart failure, left ventricular ejection fraction (LVEF) ≤45% and iron deficiency (ferritin <100 µg/L or TSAT <20%), 771 (68%) of whom had anemia (hemoglobin <12 g/dL for women; <13 g/dL for men). Patients were randomized, open-label, to FDI (n=397) or usual care (n=374) and followed for a median of 2.6 years. The primary endpoint, recurrent hospitalization for heart failure and cardiovascular death, occurred less frequently for those assigned to FDI (rate ratio 0.78 [95% CI 0.61 – 1.01); p=0.063). First-event analysis for cardiovascular death or hospitalization for heart failure, less affected by the COVID pandemic, gave similar results (hazard ratio 0.77 [95% CI 0.62 – 0.96]; p=0.022). Patients randomized to FDI reported a better Minnesota Living with Heart Failure quality-of-life, for overall (p = 0.013) and physical-domain (p = 0.00093) scores at four months.ConclusionIn patients with iron deficiency anemia and heart failure with reduced LVEF, IV FDI improves quality of life and may reduce cardiovascular events.