Shirley Sze, Iain Squire, Paul R Kalra, John G Cleland, Mark C Petrie, Philip A Kalra, Fozia Ahmed, Prithwish Banerjee, Christopher J Boos, Callum Chapman, Peter James Cowburn, Lana Dixon, Simon Duckett, Rebecca Lane, Paul Foley, Ninian N Lang, Kristopher Lyons, Robin Ray, Rebekah Schiff, Elizabeth A Thomson, Michele Robertson, Ian Ford
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引用次数: 0
Abstract
Background: Intravenous iron therapy with ferric derisomaltose (FDI) has been shown to improve outcomes in patients with heart failure with reduced ejection fraction (HFrEF) and iron deficiency. However, its effects across different age groups remain unclear. This analysis of the Effectiveness of Intravenous Iron Treatment versus Standard Care in Patients with Heart Failure and Iron Deficiency (IRONMAN) trial explored the efficacy and safety of FDI across age groups.
Methods: The IRONMAN trial was a prospective, open-label, blinded end point randomised controlled trial enrolling patients with HFrEF and iron deficiency. This prespecified analysis stratified the population into four quarters by age group: <67 years, 67-73 years, 74-79 years, >79 years. The primary outcome was a composite of recurrent heart failure hospitalisations and cardiovascular death. Secondary outcomes included changes in haemoglobin and quality of life. Clinical outcomes comparing FDI versus usual care in each age subgroup were analysed by the method of Lin et al for recurrent events and Cox proportional hazards model for time to first event. Interactions between age and treatment effects were explored.
Results: Among 1137 randomised patients (median age 73 years), the primary outcome rate ratio (FDI vs usual care) was 0.87 (95% CI 0.61 to 1.23) in patients <67 years, 0.93 (95% CI 0.66 to 1.32) in those aged 67-73 years, 0.88 (95% CI 0.59 to 1.33) in those aged 74-79 years and 0.66 (95% CI 0.45 to 0.96) in those aged >79 years (p-interaction=0.38). Improvements in haemoglobin and quality of life scores at 4 months did not differ statistically across age groups (p-interaction=0.92 and 0.64, respectively). Older patients were more symptomatic at baseline, with higher N-terminal-pro B-type natriuretic peptide levels and poorer renal function, but safety outcomes did not differ across age groups.
Conclusions: We found no evidence that the effects of FDI on heart failure hospitalisations, cardiovascular death, haemoglobin and quality of life differed by age. These findings support its use in patients with HFrEF and iron deficiency, including older adults.
背景：静脉注射脱异麦芽糖铁治疗（FDI）已被证明可以改善伴有射血分数降低（HFrEF）和缺铁的心力衰竭患者的预后。然而，它对不同年龄组的影响尚不清楚。这项对心力衰竭和缺铁患者静脉铁治疗与标准治疗的有效性分析（IRONMAN）试验探讨了FDI在不同年龄组的有效性和安全性。方法：IRONMAN试验是一项前瞻性、开放标签、盲法终点随机对照试验，纳入HFrEF和缺铁患者。这个预先指定的分析将人口按年龄组分为四组：79岁。主要结局是复发性心力衰竭住院和心血管死亡的综合结果。次要结局包括血红蛋白和生活质量的变化。通过Lin等人的复发事件方法和Cox比例风险模型分析每个年龄亚组FDI与常规护理的临床结果。探讨了年龄与治疗效果之间的相互作用。结果：在1137名随机分组的患者（中位年龄73岁）中，79岁患者的主要转归率比（FDI与常规护理）为0.87 (95% CI 0.61至1.23)（p-相互作用=0.38）。4个月时血红蛋白和生活质量评分的改善在不同年龄组之间没有统计学差异（p-interaction分别=0.92和0.64）。老年患者在基线时症状更明显，n端前b型利钠肽水平较高，肾功能较差，但安全性结果在不同年龄组之间没有差异。结论：我们没有发现FDI对心力衰竭住院、心血管死亡、血红蛋白和生活质量的影响因年龄而异的证据。这些发现支持将其用于HFrEF和缺铁患者，包括老年人。试验注册号：NCT02642562。
期刊介绍：
Heart is an international peer reviewed journal that keeps cardiologists up to date with important research advances in cardiovascular disease. New scientific developments are highlighted in editorials and put in context with concise review articles. There is one free Editor’s Choice article in each issue, with open access options available to authors for all articles. Education in Heart articles provide a comprehensive, continuously updated, cardiology curriculum.
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