Vericiguat and mortality in heart failure and reduced ejection fraction: the VICTOR trial.

VICTOR was powered to independently assess cardiovascular death.

VICTOR试验具备独立评估心血管死亡的能力。

This study reports detailed analysis on the effects of vericiguat on mortality.

本研究报告了对维立西呱对死亡率影响的详细分析。

Methods

VICTOR, a double-blind, placebo-controlled, randomized trial, enrolled 6105 ambulatory patients with HF and reduced ejection fraction (HFrEF) without recent worsening and randomized them to vericiguat or placebo.

VICTOR是一项双盲、安慰剂对照、随机试验，招募了6105名门诊心力衰竭且射血分数降低（HFrEF）患者，且近期未出现病情恶化，并将他们随机分配至维立西呱组或安慰剂组。

The main outcome for this analysis was the pre-specified secondary endpoint of cardiovascular death.

此次分析的主要结果是预先设定的心血管死亡次要终点。

All-cause death, sudden cardiac death, and death related to HF were also assessed.

同时评估了全因死亡、突发性心脏死亡和与心力衰竭相关的死亡。

Results

Over a median of 19.7 months (inter-quartile range 14.6-25.4), cardiovascular deaths occurred in 292 patients (5.7 deaths per 100 patient-years) and 346 patients (6.8 deaths per 100 patient-years) in the vericiguat and placebo groups, respectively (hazard ratio[HR] 0.83, 95% confidence interval[CI] 0.71-0.97; P = .020).

在中位随访19.7个月（四分位数范围14.6-25.4）期间，心血管死亡事件在维力西呱组和安慰剂组分别发生在292名患者（每100患者年5.7例死亡）和346名患者（每100患者年6.8例死亡）中（风险比[HR] 0.83，95%置信区间[CI] 0.71-0.97；P = .020）。

Risk of death from any cause was lower with vericiguat vs placebo (377 [7.3 deaths per 100 patient-years] vs 440 [8.6 deaths per 100 patient-years]; HR 0.84, 95% CI 0.74-0.97; P = .015).

与安慰剂相比，维力西呱组的全因死亡风险较低（377例[每100患者年7.3例死亡]对比440例[每100患者年8.6例死亡]；HR 0.84，95% CI 0.74-0.97；P = .015）。

Sudden cardiac death and HF-related deaths were lower with vericiguat vs placebo (1.6 vs 2.2 events per 100 patient-years; HR 0.75, 95% CI 0.56-0.99; P = .042 and 1.7 vs 2.4 events per 100 patient-years; HR 0.71, 95% CI 0.54-0.94; P = .016, respectively).

与安慰剂相比，心脏猝死和心力衰竭相关死亡在使用维里曲特治疗的患者中较低（每100患者年1.6比2.2事件；风险比0.75，95%置信区间0.56-0.99；P = .042和每100患者年1.7比2.4事件；风险比0.71，95%置信区间0.54-0.94；P = .016，分别）。

Lower mortality rates were consistent across subgroups including baseline therapy.

在包括基线治疗在内的各个亚组中，较低的死亡率是一致的。

Consistent cardiovascular and all-cause mortality benefit was seen across baseline N-terminal pro-B-type natriuretic peptide levels.

在不同基线N端前体B型利钠肽水平的患者中，均观察到一致的心血管和全因死亡率的益处。

Conclusions

In ambulatory well-treated participants with HFrEF, vericiguat was associated with clinically meaningful reductions in the key secondary outcome of cardiovascular death, as well as all-cause mortality.

在门诊接受良好治疗的射血分数降低的心力衰竭患者中，维立西呱与心血管死亡这一关键次要结果以及全因死亡率的临床意义降低相关。