BHF Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow G12 8TA, UK.
Changi General Hospital, Singapore, Singapore.
Cardiovasc Res. 2023 Mar 17;119(1):213-220. doi: 10.1093/cvr/cvab317.
To investigate the effect of high-dose iron vs. low-dose intravenous (IV) iron on myocardial infarction (MI) in patients on maintenance haemodialysis.
This was a pre-specified analysis of secondary endpoints of the Proactive IV Iron Therapy in Hemodialysis Patients trial (PIVOTAL) randomized, controlled clinical trial. Adults who had started haemodialysis within the previous year, who had a ferritin concentration <400 μg per litre and a transferrin saturation <30% were randomized to high-dose or low-dose IV iron. The main outcome measure for this analysis was fatal or non-fatal MI. Over a median of 2.1 years of follow-up, 8.4% experienced a MI. Rates of type 1 MIs (3.2/100 patient-years) were 2.5 times higher than type 2 MIs (1.3/100 patient-years). Non-ST-elevation MIs (3.3/100 patient-years) were 6 times more common than ST-elevation MIs (0.5/100 patient-years). Mortality was high after non-fatal MI (1- and 2-year mortality of 40% and 60%, respectively). In time-to-first event analyses, proactive high-dose IV iron reduced the composite endpoint of non-fatal and fatal MI [hazard ratio (HR) 0.69, 95% confidence interval (CI) 0.52-0.93, P = 0.01] and non-fatal MI (HR 0.69, 95% CI 0.51-0.93; P = 0.01) when compared with reactive low-dose IV iron. There was less effect of high-dose IV iron on recurrent MI events than on the time-to-first event analysis.
In total, 8.4% of patients on maintenance haemodialysis had an MI over 2 years. High-dose compared to low-dose IV iron reduced MI in patients receiving haemodialysis.
2013-002267-25.
研究高剂量静脉铁（IV 铁）与低剂量 IV 铁对维持性血液透析患者心肌梗死（MI）的影响。
这是 Proactive IV Iron Therapy in Hemodialysis Patients 试验（PIVOTAL）的预先设定的次要终点的分析，该试验是一项随机对照临床试验。在过去一年中开始血液透析、铁蛋白浓度 <400μg/L 且转铁蛋白饱和度 <30%的成年人被随机分配至高剂量或低剂量 IV 铁。该分析的主要终点是致命或非致命性 MI。在中位数为 2.1 年的随访期间，8.4%的患者发生 MI。1 型 MI（3.2/100 患者年）的发生率是 2 型 MI（1.3/100 患者年）的 2.5 倍。非 ST 段抬高型 MI（3.3/100 患者年）的发生率是非 ST 段抬高型 MI（0.5/100 患者年）的 6 倍。非致命性 MI 后死亡率较高（1 年和 2 年死亡率分别为 40%和 60%）。在首次事件时间分析中，主动高剂量 IV 铁降低了非致命性和致命性 MI 的复合终点[风险比（HR）0.69，95%置信区间（CI）0.52-0.93，P = 0.01]和非致命性 MI（HR 0.69，95% CI 0.51-0.93；P = 0.01）与反应性低剂量 IV 铁相比。高剂量 IV 铁对复发性 MI 事件的影响小于对首次事件时间分析的影响。
在维持性血液透析患者中，共有 8.4%的患者在 2 年内发生 MI。与低剂量 IV 铁相比，高剂量 IV 铁可降低接受血液透析治疗的患者的 MI 发生率。
2013-002267-25。
