维立西呱与射血分数降低的心力衰竭患者的健康相关生活质量：来自 VICTORIA 试验的结果。

Vericiguat and Health-Related Quality of Life in Patients With Heart Failure With Reduced Ejection Fraction: Insights From the VICTORIA Trial.

机构信息

Department of Medicine, University of Mississippi Medical Center, Jackson (J.B.).

Duke Clinical Research Institute (A.S., A.F.H., K.J.A.), Duke University School of Medicine, Durham, NC.

出版信息

Circ Heart Fail. 2022 Jun;15(6):e009337. doi: 10.1161/CIRCHEARTFAILURE.121.009337. Epub 2022 Jun 3.

DOI:10.1161/CIRCHEARTFAILURE.121.009337

PMID:35656822

Abstract

BACKGROUND

We examined the effects of vericiguat compared with placebo in patients with heart failure with reduced ejection fraction enrolled in VICTORIA (Vericiguat Global Study in Patients With Heart Failure With Reduced Ejection Fraction) on health status outcomes measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and evaluated whether clinical outcomes varied by baseline KCCQ score.

METHODS

KCCQ was completed at baseline and 4, 16, and 32 weeks. We assessed treatment effect on KCCQ using a mixed-effects model adjusting for baseline KCCQ and stratification variables. Cox proportional-hazards modeling was performed to evaluate the effect of vericiguat on clinical outcomes by tertiles of baseline KCCQ clinical summary score (CSS), total symptom score (TSS), and overall summary score (OSS).

RESULTS

Of 5050 patients, 4664, 4741, and 4470 had KCCQ CSS (median [25th to 75th], 65.6 [45.8-81.8]), TSS (68.8 [47.9-85.4]), and OSS (59.9 [42.0-77.1]) at baseline; 94%, 88%, and 82% had data at 4, 16, and 32 weeks. At 16 weeks, CSS improved by a median of 6.3 in both arms; no significant differences in improvement were seen for TSS and OSS between the 2 groups (=0.69, 0.97, and 0.13 for CSS, TSS, and OSS). Trends were similar at 4 and 32 weeks. Vericiguat versus placebo reduced cardiovascular death or heart failure hospitalization risk similarly across tertiles of baseline KCCQ CSS, TSS, and OSS (interaction =0.13, 0.21, and 0.65).

CONCLUSIONS

Vericiguat did not significantly improve KCCQ scores compared with placebo. Vericiguat reduced the risk of cardiovascular death or heart failure hospitalization across the range of baseline health status.

REGISTRATION

URL: https://www.

CLINICALTRIALS

gov; Unique identifier: NCT02861534.

摘要

背景

我们研究了维立西呱与安慰剂在射血分数降低的心力衰竭患者中的疗效，这些患者参加了 VICTORIA 研究（维立西呱在射血分数降低的心力衰竭患者中的全球研究），通过堪萨斯城心肌病问卷（KCCQ）评估健康状况，评估了基线 KCCQ 评分对临床结局的影响。

方法

KCCQ 在基线和 4、16、32 周进行评估。我们使用混合效应模型调整基线 KCCQ 和分层变量来评估 KCCQ 治疗效果。Cox 比例风险模型用于评估维立西呱对 KCCQ 临床总结评分（CSS）、总症状评分（TSS）和总综合评分（OSS）的三个三分位数的临床结局的影响。

结果

在 5050 例患者中，4664、4741 和 4470 例患者在基线时有 KCCQ CSS（中位数[25%到 75%]，65.6 [45.8-81.8]）、TSS（68.8 [47.9-85.4]）和 OSS（59.9 [42.0-77.1]）；94%、88%和 82%在 4、16 和 32 周时有数据。在 16 周时，两组的 CSS 均改善了中位数 6.3 分；两组 TSS 和 OSS 之间无明显差异（CSS、TSS 和 OSS 的差异分别为 0.69、0.97 和 0.13）。4 周和 32 周时的趋势相似。与安慰剂相比，维立西呱降低心血管死亡或心力衰竭住院风险在 KCCQ CSS、TSS 和 OSS 的三个三分位数中相似（交互=0.13、0.21 和 0.65）。