Foley Paul W, Kalra Paul R, Cleland John G F, Petrie Mark C, Kalra Philip A, Squire Ian, Campbell Philip, Chapman Callum, Donnelly Patrick, Graham Fraser, Hannah Andrew, Lang Ninian N, Matthews Iain, Leslie Stephen J, Pellicori Pierpaolo, Piper Sue, Ray Robin, Savage Hernry O, Spencer Chales, Walsh John, Wong Yuk-Ki, Ford Ian
The Great Western Hospital, Swindon, UK.
Department of Cardiology, Portsmouth Hospitals University NHS Trust, Portsmouth, UK.
Eur J Heart Fail. 2025 Jan;27(1):166-173. doi: 10.1002/ejhf.3504. Epub 2024 Oct 25.
Concerns exist that intravenous (IV) iron might increase the risk of infections. The IRONMAN trial provided an opportunity to investigate whether giving IV ferric derisomaltose (FDI) to patients with heart failure and iron deficiency alters the rate of hospitalization or death due to infections.
IRONMAN was a randomized trial of IV FDI versus usual care in patients with symptomatic heart failure, left ventricular ejection fraction (LVEF) ≤45%, and transferrin saturation (TSAT) <20% or ferritin <100 μg/L. Infection was a pre-specified, blindly-adjudicated, safety endpoint. The primary analysis of interest was infection as the main reason for hospitalization or death, using first and recurrent events analyses. The composite primary event of interest tended to be lower in those randomized to FDI when analysed as first (hazard ratio [HR] 0.79, 95% confidence interval [CI] 0.62-1.01, p = 0.055) or recurrent event (rate ratio 0.85, 95% CI 0.64-1.13, p = 0.089). The composite results were driven by fewer hospitalizations for infection (HR 0.76, 95% CI 0.49-0.98, p = 0.032), with 5% fewer patients (absolute reduction) experiencing such an event if assigned to FDI. Similar trends were observed for recurrent events (HR 0.82, 95% CI 0.62-1.10). Further analyses suggested that the reduction in hospitalizations due to infection with FDI was restricted to patients with TSAT <20%.
In patients with heart failure and a reduced LVEF, correction of iron deficiency is not associated with an increased risk of hospitalization or death from infection, and may reduce such events, especially when TSAT is <20%.
ClinicalTrials.gov, NCT02642562.
有人担心静脉注射铁剂可能会增加感染风险。IRONMAN试验提供了一个机会，来探究给心力衰竭且缺铁的患者静脉注射异麦芽糖铁（FDI）是否会改变因感染导致的住院率或死亡率。
IRONMAN是一项针对有症状心力衰竭、左心室射血分数（LVEF）≤45%且转铁蛋白饱和度（TSAT）<20%或铁蛋白<100μg/L的患者进行的静脉注射FDI与常规治疗的随机试验。感染是一个预先设定的、经过盲法判定的安全终点。感兴趣的主要分析是以感染作为住院或死亡的主要原因，采用首次和复发事件分析。当作为首次事件分析时（风险比[HR]0.79，95%置信区间[CI]0.62 - 1.01，p = 0.055）或复发事件分析时（率比0.85，95%CI 0.64 - 1.13，p = 0.089），随机接受FDI治疗的患者中，感兴趣的复合主要事件往往较低。复合结果是由于感染导致的住院次数减少（HR 0.76，95%CI 0.49 - 0.98，p = 0.032），如果分配到FDI组，经历此类事件的患者减少5%（绝对降低）。复发事件也观察到类似趋势（HR 0.82，95%CI 0.62 - 1.10）。进一步分析表明，FDI导致的因感染住院次数减少仅限于TSAT<20%的患者。
在心力衰竭且LVEF降低的患者中，纠正缺铁与因感染导致的住院或死亡风险增加无关，且可能减少此类事件，尤其是当TSAT<20%时。
ClinicalTrials.gov，NCT02642562。
