GALACTIC-HF 试验中射血分数降低的心力衰竭的性别差异。
Sex Differences in Heart Failure With Reduced Ejection Fraction in the GALACTIC-HF Trial.
机构信息
Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Division of Cardiology, Duke University School of Medicine and Duke Clinical Research Institute, Durham, North Carolina, USA.
出版信息
JACC Heart Fail. 2023 Dec;11(12):1729-1738. doi: 10.1016/j.jchf.2023.07.029. Epub 2023 Oct 11.
BACKGROUND
Women with heart failure with reduced ejection fraction (HFrEF) receive less guideline-recommended therapy and experience worse quality of life than men.
OBJECTIVES
The authors sought to assess differences in baseline characteristics, outcomes, efficacy, and safety of omecamtiv mecarbil between men and women enrolled in the GALACTIC-HF (Registrational Study With Omecamtiv Mecarbil [AMG 423] to Treat Chronic Heart Failure With Reduced Ejection Fraction) study.
METHODS
In GALACTIC-HF, patients with symptomatic heart failure with EF of 35% or less, recent heart failure event, and elevated natriuretic peptides were randomized to omecamtiv mecarbil or placebo. The current analysis investigated differences in baseline characteristics, clinical outcomes, and efficacy and safety of omecamtiv mecarbil between men and women.
RESULTS
Of 8,232 patients analyzed, 21.2% were women. Women more likely self-identified as being Black, had worse symptoms (lower Kansas City Cardiomyopathy Questionnaire Total Symptom Score [KCCQ-TSS]), and were less likely to be treated with angiotensin receptor/neprilysin inhibitor and devices at baseline. Compared with men, women had lower rates of the primary endpoint (adjusted HR: 0.80, 95% CI: 0.73-0.88). Sex did not significantly modify omecamtiv mecarbil's treatment effect (P interaction = 0.68). Women also had 20% less risk of cardiovascular death, heart failure event, and all-cause death. Women participants had lower rates of serious adverse events.
CONCLUSIONS
Women participants of the GALACTIC-HF trial had worse quality of life and were less likely to be treated with guideline-based therapies at baseline. Despite KCCQ-TSS being predictive of poor outcomes in this population, women had a 20% lower risk of an HF event or cardiovascular death compared with men. The beneficial effect of omecamtiv mecarbil did not significantly differ by sex. (Registrational Study With Omecamtiv Mecarbil [AMG 423] to Treat Chronic Heart Failure With Reduced Ejection Fraction [GALACTIC-HF]; NCT02929329).
背景
射血分数降低的心力衰竭（HFrEF）女性接受的指南推荐治疗比男性少，生活质量也更差。
目的
作者旨在评估在 GALACTIC-HF 研究中，接受 omecamtiv mecarbil 治疗的男性和女性在基线特征、结局、疗效和安全性方面的差异。
方法
在 GALACTIC-HF 中，EF 为 35%或更低、近期心力衰竭事件和升高的利钠肽的有症状心力衰竭患者被随机分配至 omecamtiv mecarbil 或安慰剂。本分析研究了男性和女性在基线特征、临床结局以及 omecamtiv mecarbil 的疗效和安全性方面的差异。
结果
在分析的 8232 名患者中，21.2%为女性。女性更可能自我认同为黑人，症状更严重（较低的堪萨斯城心肌病问卷总症状评分[KCCQ-TSS]），并且在基线时不太可能接受血管紧张素受体/脑啡肽酶抑制剂和器械治疗。与男性相比，女性的主要终点发生率较低（调整后的 HR：0.80，95%CI：0.73-0.88）。性别并未显著改变 omecamtiv mecarbil 的治疗效果（P 交互=0.68）。女性的心血管死亡、心力衰竭事件和全因死亡风险也降低了 20%。女性参与者的严重不良事件发生率较低。
结论
GALACTIC-HF 试验的女性参与者生活质量较差，并且在基线时不太可能接受基于指南的治疗。尽管 KCCQ-TSS 可预测该人群的不良结局，但与男性相比，女性发生心力衰竭事件或心血管死亡的风险降低了 20%。omecamtiv mecarbil 的有益效果在性别间无显著差异。（Omecamtiv Mecarbil [AMG 423]治疗射血分数降低的慢性心力衰竭的注册研究[GALACTIC-HF]；NCT02929329）。
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