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铁羧基麦芽糖静脉注射治疗缺铁性和急性心力衰竭患者的疗效与缺血病因的关系:来自 AFFIRM-AHF 试验的见解。

Impact of ischaemic aetiology on the efficacy of intravenous ferric carboxymaltose in patients with iron deficiency and acute heart failure: insights from the AFFIRM-AHF trial.

机构信息

Insitute of Cardiology, ASST Spedali Civili, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Brescia, Italy.

Institute of Heart Diseases, Wroclaw Medical University, Poland.

出版信息

Eur J Heart Fail. 2022 Oct;24(10):1928-1939. doi: 10.1002/ejhf.2630. Epub 2022 Sep 23.

Abstract

AIMS

In AFFIRM-AHF, intravenous ferric carboxymaltose (FCM) reduced heart failure (HF) hospitalisations and improved quality of life versus placebo in iron-deficient patients stabilised after an acute HF episode. This analysis explored the effects of FCM versus placebo in patients with ischaemic and non-ischaemic HF aetiology.

METHODS AND RESULTS

We included 1082 patients from AFFIRM-AHF: 590 with ischaemic HF (defined as investigator-reported ischaemic HF aetiology and/or prior acute myocardial infarction and/or prior coronary revascularisation) and 492 with non-ischaemic HF. The prevalences of male sex, comorbidities, and history of HF were higher in the ischaemic versus non-ischaemic HF subgroup. Annualised event rates for the primary composite outcome of total HF hospitalisations and cardiovascular death with FCM versus placebo were 65.3 versus 100.6 per 100 patient-years in the ischaemic HF subgroup (rate ratio [RR] 0.65, 95% confidence interval [CI] 0.47-0.89, p = 0.007) and 58.3 versus 52.5 in the non-ischaemic HF subgroup (RR 1.11, 95% CI 0.75-1.66, p = 0.60) (p  = 0.039). An interaction between HF aetiology and treatment effect was also observed for the secondary outcome of total HF hospitalisations (p  = 0.038). A nominal increase in quality of life, assessed using the 12-item Kansas City Cardiomyopathy Questionnaire, was observed with FCM versus placebo, within each subgroup.

CONCLUSIONS

Heart failure hospitalisations and cardiovascular deaths occurred at a higher rate in patients with ishaemic versus those with non-ischaemic HF and were reduced by FCM versus placebo only in ischaemic patients. Further studies are needed to assess the role of aetiology in FCM efficacy.

摘要

目的

在 AFFIRM-AHF 研究中,静脉注射羧基麦芽糖铁(FCM)降低了缺铁性心力衰竭(HF)患者在急性 HF 发作后稳定期的 HF 住院率并改善了生活质量,而安慰剂组则没有。本分析探讨了 FCM 与安慰剂在缺血性和非缺血性 HF 病因患者中的疗效差异。

方法和结果

我们纳入了 AFFIRM-AHF 研究中的 1082 例患者:590 例缺血性 HF(定义为研究者报告的缺血性 HF 病因和/或既往急性心肌梗死和/或既往冠状动脉血运重建)和 492 例非缺血性 HF。与非缺血性 HF 亚组相比,缺血性 HF 亚组的男性比例、合并症和 HF 病史更高。FCM 与安慰剂相比,缺血性 HF 亚组的主要复合终点(HF 住院和心血管死亡的总和)的年化事件率分别为 65.3 与 100.6 例/100 患者年(风险比 [RR] 0.65,95%置信区间 [CI] 0.47-0.89,p=0.007),而非缺血性 HF 亚组为 58.3 与 52.5(RR 1.11,95% CI 0.75-1.66,p=0.60)(p=0.039)。HF 病因和治疗效果之间也存在交互作用(p=0.038)。与安慰剂相比,FCM 还可提高 12 项堪萨斯城心肌病调查问卷的生活质量评分(p=0.038),但仅在缺血性 HF 患者中观察到这种作用。需要进一步研究以评估病因在 FCM 疗效中的作用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/116e/9826371/4ecc214d58b3/EJHF-24-1928-g004.jpg

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