van Veldhuisen Dirk J, Ponikowski Piotr, van der Meer Peter, Metra Marco, Böhm Michael, Doletsky Artem, Voors Adriaan A, Macdougall Iain C, Anker Stefan D, Roubert Bernard, Zakin Lorraine, Cohen-Solal Alain
From Department of Cardiology, University Medical Center Groningen, University of Groningen, The Netherlands (D.J.v.V., P.v.d.M., A.A.V.); Department of Heart Diseases, Medical University, Clinical Military Hospital, Wroclaw, Poland (P.P.); Department of Cardiology, University Hospital, Brescia, Italy (M.M.); Universitätsklinikum des Saarlandes, Homburg/Saar, Germany (M.B.); I.M. Sechenov First Moscow State Medical University, Moscow, Russia (A.D.); King's College Hospital, London, United Kingdom (I.C.M.); Division of Cardiology and Metabolism, Department of Cardiology (CVK) and Berlin-Brandenburg Center for Regenerative Therapies (S.D.A.); Deutsches Zentrum für Herz-Kreislauf-Forschung, Berlin (S.D.A.); Charité Universitätsmedizin Berlin, Germany (S.D.A.); Department of Cardiology and Pneumology, University Medicine Göttingen, Germany (S.D.A.); Vifor Pharma, Glattbrugg, Switzerland (B.R., L.Z.); and Hopital Lariboisiere, University Paris Diderot, UMR-S942, France (A.C.-S.).
Circulation. 2017 Oct 10;136(15):1374-1383. doi: 10.1161/CIRCULATIONAHA.117.027497. Epub 2017 Jul 12.
Iron deficiency is common in patients with heart failure (HF) and is associated with reduced exercise capacity and poor outcomes. Whether correction of iron deficiency with (intravenous) ferric carboxymaltose (FCM) affects peak oxygen consumption [peak VO], an objective measure of exercise intolerance in HF, has not been examined.
We studied patients with systolic HF (left ventricular ejection fraction ≤45%) and mild to moderate symptoms despite optimal HF medication. Patients were randomized 1:1 to treatment with FCM for 24 weeks or standard of care. The primary end point was the change in peak VO from baseline to 24 weeks. Secondary end points included the effect on hematinic and cardiac biomarkers, quality of life, and safety. For the primary analysis, patients who died had a value of 0 imputed for 24-week peak VO. Additional sensitivity analyses were performed to determine the impact of imputation of missing peak VO data.
A total of 172 patients with HF were studied and received FCM (n=86) or standard of care (control group, n=86). At baseline, the groups were well matched; mean age was 64 years, 75% were male, mean left ventricular ejection fraction was 32%, and peak VO was 13.5 mL/min/kg. FCM significantly increased serum ferritin and transferrin saturation. At 24 weeks, peak VO had decreased in the control group (least square means -1.19±0.389 mL/min/kg) but was maintained on FCM (-0.16±0.387 mL/min/kg; =0.020 between groups). In a sensitivity analysis, in which missing data were not imputed, peak VO at 24 weeks decreased by -0.63±0.375 mL/min/kg in the control group and by -0.16±0.373 mL/min/kg in the FCM group; =0.23 between groups). Patients' global assessment and functional class as assessed by the New York Heart Association improved on FCM versus standard of care.
Treatment with intravenous FCM in patients with HF and iron deficiency improves iron stores. Although a favorable effect on peak VO was observed on FCM, compared with standard of care in the primary analysis, this effect was highly sensitive to the imputation strategy for peak VO among patients who died. Whether FCM is associated with an improved outcome in these high-risk patients needs further study.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01394562.
缺铁在心力衰竭（HF）患者中很常见，且与运动能力下降和不良预后相关。静脉注射羧麦芽糖铁（FCM）纠正缺铁是否会影响峰值耗氧量[峰值VO₂]（一种衡量HF患者运动不耐受的客观指标）尚未得到研究。
我们研究了尽管接受了最佳HF药物治疗但仍有轻度至中度症状的收缩性HF（左心室射血分数≤45%）患者。患者按1:1随机分为接受FCM治疗24周或接受标准治疗。主要终点是从基线到24周时峰值VO₂的变化。次要终点包括对血液学和心脏生物标志物、生活质量及安全性的影响。对于主要分析，死亡患者的24周峰值VO₂值按0估算。进行了额外的敏感性分析以确定估算缺失的峰值VO₂数据的影响。
共研究了172例HF患者，他们接受了FCM治疗（n = 86）或标准治疗（对照组，n = 86）。基线时，两组匹配良好；平均年龄为64岁，75%为男性，平均左心室射血分数为32%，峰值VO₂为13.5 mL/min/kg。FCM显著提高了血清铁蛋白和转铁蛋白饱和度。在24周时，对照组的峰值VO₂下降（最小二乘均值为-1.19±0.389 mL/min/kg），而接受FCM治疗的患者则维持在（-0.16±0.387 mL/min/kg；两组间P = 0.020）。在一项未估算缺失数据的敏感性分析中，对照组24周时的峰值VO₂下降了-0.63±0.375 mL/min/kg，FCM组下降了-0.16±0.373 mL/min/kg；两组间P = 0.23）。与标准治疗相比，接受FCM治疗的患者经纽约心脏协会评估的整体评估和功能分级有所改善。
HF合并缺铁患者静脉注射FCM治疗可改善铁储备。虽然在主要分析中观察到FCM对峰值VO₂有有利影响，但与标准治疗相比，这种影响对死亡患者峰值VO₂的估算策略高度敏感。FCM是否与这些高危患者的预后改善相关需要进一步研究。
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