Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction
Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction
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维立西呱用于射血分数降低的心力衰竭患者
DOI：
10.1056/nejmoa1915928
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发表时间：
2020-05-14
影响因子：
158.5
通讯作者：
O'Connor, Christopher M.
中科院分区：
文献类型：
--
作者：
Armstrong, Paul W.;Pieske, Burkert;O'Connor, Christopher M.
背景
维立西呱（一种新型口服可溶性鸟苷酸环化酶刺激剂）在近期住院或接受过静脉利尿剂治疗的射血分数降低的心力衰竭患者中的作用尚不明确。
方法
在这项3期、随机、双盲、安慰剂对照试验中，我们将5050例慢性心力衰竭（纽约心脏协会心功能Ⅱ、Ⅲ或Ⅳ级）且射血分数低于45%的患者，在基于指南的药物治疗基础上，随机分配接受维立西呱（目标剂量为每日1次，每次10mg）或安慰剂。主要结局是心血管原因死亡或首次因心力衰竭住院的复合终点。
结果
中位随访10.8个月期间，维立西呱组2526例患者中有897例（35.5%）发生主要结局事件，安慰剂组2524例患者中有972例（38.5%）发生（风险比，0.90；95%置信区间[CI]，0.82 - 0.98；P = 0.02）。维立西呱组共有691例患者（27.4%）因心力衰竭住院，安慰剂组有747例患者（29.6%）因心力衰竭住院（风险比，0.90；95%CI，0.81 - 1.00）。维立西呱组有414例患者（16.4%）因心血管原因死亡，安慰剂组有441例患者（17.5%）因心血管原因死亡（风险比，0.93；95%CI，0.81 - 1.06）。维立西呱组957例患者（37.9%）发生任何原因死亡或因心力衰竭住院的复合终点，安慰剂组1032例患者（40.9%）发生（风险比，0.90；95%CI，0.83 - 0.98；P = 0.02）。维立西呱组9.1%的患者出现症状性低血压，安慰剂组7.9%的患者出现症状性低血压（P = 0.12），维立西呱组4.0%的患者出现晕厥，安慰剂组3.5%的患者出现晕厥（P = 0.30）。
结论
在高危心力衰竭患者中，接受维立西呱治疗的患者心血管原因死亡或因心力衰竭住院的发生率低于接受安慰剂治疗的患者。（由默沙东[默克的子公司]和拜耳资助；VICTORIA临床试验注册号，NCT02861534）
慢性心力衰竭且射血分数降低的患者在基于指南的药物治疗基础上，被随机分配接受可溶性鸟苷酸环化酶刺激剂维立西呱或安慰剂。接受维立西呱治疗的患者心血管原因死亡或首次因心力衰竭住院的发生率较低。
BackgroundThe effect of vericiguat, a novel oral soluble guanylate cyclase stimulator, in patients with heart failure and reduced ejection fraction who had recently been hospitalized or had received intravenous diuretic therapy is unclear.MethodsIn this phase 3, randomized, double-blind, placebo-controlled trial, we assigned 5050 patients with chronic heart failure (New York Heart Association class II, III, or IV) and an ejection fraction of less than 45% to receive vericiguat (target dose, 10 mg once daily) or placebo, in addition to guideline-based medical therapy. The primary outcome was a composite of death from cardiovascular causes or first hospitalization for heart failure.ResultsOver a median of 10.8 months, a primary-outcome event occurred in 897 of 2526 patients (35.5%) in the vericiguat group and in 972 of 2524 patients (38.5%) in the placebo group (hazard ratio, 0.90; 95% confidence interval [CI], 0.82 to 0.98; P=0.02). A total of 691 patients (27.4%) in the vericiguat group and 747 patients (29.6%) in the placebo group were hospitalized for heart failure (hazard ratio, 0.90; 95% CI, 0.81 to 1.00). Death from cardiovascular causes occurred in 414 patients (16.4%) in the vericiguat group and in 441 patients (17.5%) in the placebo group (hazard ratio, 0.93; 95% CI, 0.81 to 1.06). The composite of death from any cause or hospitalization for heart failure occurred in 957 patients (37.9%) in the vericiguat group and in 1032 patients (40.9%) in the placebo group (hazard ratio, 0.90; 95% CI, 0.83 to 0.98; P=0.02). Symptomatic hypotension occurred in 9.1% of the patients in the vericiguat group and in 7.9% of the patients in the placebo group (P=0.12), and syncope occurred in 4.0% of the patients in the vericiguat group and in 3.5% of the patients in the placebo group (P=0.30).ConclusionsAmong patients with high-risk heart failure, the incidence of death from cardiovascular causes or hospitalization for heart failure was lower among those who received vericiguat than among those who received placebo. (Funded by Merck Sharp & Dohme [a subsidiary of Merck] and Bayer; VICTORIA ClinicalTrials.gov number, NCT02861534.)Patients with chronic heart failure and a reduced ejection fraction were randomly assigned to the soluble guanylate cyclase stimulator vericiguat or placebo, in addition to guideline-based medical therapy. The incidence of death from cardiovascular causes or first hospitalization for heart failure was lower among patients who received vericiguat.