TY - JOUR
T1 - Adjudication of Hospitalizations and Deaths in the IRONMAN Trial of Intravenous Iron for Heart Failure
AU - IRONMAN Study Group
AU - Cleland, John G.F.
AU - Pellicori, Pierpaolo
AU - Graham, Fraser J.
AU - Lane, Rebecca
AU - Petrie, Mark C.
AU - Ahmed, Fozia
AU - Squire, Iain B.
AU - Ludman, Andrew
AU - Japp, Alan
AU - Al-Mohammad, Abdallah
AU - Clark, Andrew L.
AU - Szwejkowski, Ben
AU - Critoph, Chris
AU - Chong, Victor
AU - Schiff, Rebekah
AU - Nageh, Thuraia
AU - Glover, Jason
AU - McMurray, John J.V.
AU - Thomson, Elizabeth A.
AU - Robertson, Michele
AU - Ford, Ian
AU - Kalra, Philip A.
AU - Kalra, Paul R.
N1 - Publisher Copyright:
© 2024 The Authors
PY - 2024/10/29
Y1 - 2024/10/29
N2 - Background Patients with heart failure and iron deficiency have diverse causes for hospitalization and death that might be affected by iron repletion. Objectives The purpose of this study was to explore causes of hospitalizations and deaths in a randomized trial (IRONMAN) of heart failure comparing intravenous ferric derisomaltose (FDI) (n = 568) and usual care (n = 569). Methods Patients with heart failure, left ventricular ejection fraction ≤45%, and either transferrin saturation <20% or serum ferritin <100 μg/L were enrolled. Median follow-up was 2.7 years (Q1-Q3: 1.8-3.6 years). A committee adjudicated the main and contributory causes of unplanned hospitalizations and deaths. RRs (rate ratios) for selected recurrent events with 95% CIs are also reported. Results Compared with usual care, patients randomized to FDI had fewer unplanned hospitalizations (RR: 0.83; 95% CI: 0.71-0.97; P = 0.02), with similar reductions in cardiovascular (RR: 0.83; 95% CI: 0.69-1.01) and noncardiovascular (RR: 0.83; 95% CI: 0.67-1.03) hospitalizations, as well as hospitalizations for heart failure (RR: 0.78; 95% CI: 0.60-1.00), respiratory disease (RR: 0.70; 95% CI: 0.53-0.97), or infection (RR: 0.82; 95% CI: 0.66-1.03). Heart failure was the main cause for 26% of hospitalizations and contributed to or complicated a further 12%. Infection caused or contributed to 38% of all hospitalizations, including 27% of heart failure hospitalizations. Patterns of cardiovascular and all-cause mortality were similar for patients assigned to FDI or usual care. Conclusions In IRONMAN, FDI exerted similar reductions in cardiovascular and noncardiovascular hospitalizations, suggesting that correcting iron deficiency might increase resistance or resilience to a broad range of problems that cause hospitalizations in patients with heart failure.
AB - Background Patients with heart failure and iron deficiency have diverse causes for hospitalization and death that might be affected by iron repletion. Objectives The purpose of this study was to explore causes of hospitalizations and deaths in a randomized trial (IRONMAN) of heart failure comparing intravenous ferric derisomaltose (FDI) (n = 568) and usual care (n = 569). Methods Patients with heart failure, left ventricular ejection fraction ≤45%, and either transferrin saturation <20% or serum ferritin <100 μg/L were enrolled. Median follow-up was 2.7 years (Q1-Q3: 1.8-3.6 years). A committee adjudicated the main and contributory causes of unplanned hospitalizations and deaths. RRs (rate ratios) for selected recurrent events with 95% CIs are also reported. Results Compared with usual care, patients randomized to FDI had fewer unplanned hospitalizations (RR: 0.83; 95% CI: 0.71-0.97; P = 0.02), with similar reductions in cardiovascular (RR: 0.83; 95% CI: 0.69-1.01) and noncardiovascular (RR: 0.83; 95% CI: 0.67-1.03) hospitalizations, as well as hospitalizations for heart failure (RR: 0.78; 95% CI: 0.60-1.00), respiratory disease (RR: 0.70; 95% CI: 0.53-0.97), or infection (RR: 0.82; 95% CI: 0.66-1.03). Heart failure was the main cause for 26% of hospitalizations and contributed to or complicated a further 12%. Infection caused or contributed to 38% of all hospitalizations, including 27% of heart failure hospitalizations. Patterns of cardiovascular and all-cause mortality were similar for patients assigned to FDI or usual care. Conclusions In IRONMAN, FDI exerted similar reductions in cardiovascular and noncardiovascular hospitalizations, suggesting that correcting iron deficiency might increase resistance or resilience to a broad range of problems that cause hospitalizations in patients with heart failure.
KW - heart failure
KW - hospitalizations
KW - intravenous iron
KW - iron deficiency
KW - randomized trial
UR - http://www.scopus.com/inward/record.url?scp=85206159279&partnerID=8YFLogxK
U2 - 10.1016/j.jacc.2024.08.052
DO - 10.1016/j.jacc.2024.08.052
M3 - Article
C2 - 39443013
AN - SCOPUS:85206159279
SN - 0735-1097
VL - 84
SP - 1704
EP - 1717
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 18
ER -