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沙库巴曲缬沙坦治疗射血分数降低的急性失代偿心力衰竭脆弱期的疗效和安全性:一项多中心、评估者盲法、前瞻性、观察性队列研究。

Efficacy and Safety of Sacubitril/Valsartan Therapy for Acute Decompensated Heart Failure with Reduced Ejection Fraction during the Vulnerable Phase: A Multicenter, Assessor-Blinded, Prospective, Observational, Cohort Study.

机构信息

Department of Cardiology, The Affiliated Hospital of Southwest Medical University, Luzhou, China.

Department of Cardiology, Chongqing Kanghua Zhonglian Cardiovascular Hospital, Chong Qing, China.

出版信息

Cardiology. 2021;146(3):335-344. doi: 10.1159/000512418. Epub 2021 Mar 29.

DOI:10.1159/000512418
PMID:33780933
Abstract

BACKGROUND

The 3-month period after hospitalization for acute cardiac failure is a vulnerable phase with the highest risk of mortality and rehospitalization. Safety and efficacy of early initiation of sacubitril/valsartan during the index hospitalization for acute decompensated heart failure (ADHF) is unclear. Therefore, we tested whether sacubitril/valsartan could result in a lower rate of a composite outcome of first hospitalization for heart failure and death from cardiovascular causes compared to inhibition of the renin-angiotensin system alone.

METHODS

We enrolled patients hospitalized for ADHF and reduced ejection fraction at 4 sites; patients were divided into a sacubitril/valsartan group or an angiotensin-converting enzyme inhibitor (ACEI)/angiotensin receptor blocker (ARB) group. All patients were followed up for 3 months after discharge. The primary endpoint was outcomes as a composite of death from cardiovascular causes and rehospitalization for heart failure.

RESULTS

In total, 251 patients who received sacubitril/valsartan and 251 patients who received ACEIs/ARBs had similar propensity scores and were included and compared. The primary endpoint was reached in 40 patients (15.9%) treated with sacubitril/valsartan and in 59 patients (23.5%) managed by ACEI/ARB (HR, 0.650; 95% CI: 0.435-0.971; p = 0.035). The NYHA class improved in 72.1% of patients in the sacubitril/valsartan group and in 59.8% of patients in the ACEI/ARB group (HR, 1.303; 95% CI: 1.097-1.548, p = 0.004). The key safety outcomes endpoints did not significantly differ.

CONCLUSIONS

Among patients hospitalized with ADHF and reduced left ventricular ejection fraction, we observed that sacubitril/valsartan therapy led to reduction in death from cardiovascular causes and rehospitalizations for heart failure when compared to ACEI/ARB therapy alone during the vulnerable phase. Our results support that sacubitril/valsartan may be administered early in the vulnerable phase after ADHF and improves NYHA class.

摘要

背景

急性心力衰竭住院后 3 个月是一个脆弱期,死亡率和再住院率最高。急性失代偿性心力衰竭(ADHF)指数住院期间早期开始使用沙库巴曲缬沙坦的安全性和疗效尚不清楚。因此,我们测试了沙库巴曲缬沙坦是否能降低首次心力衰竭住院和心血管原因死亡的复合结局发生率,与单独抑制肾素-血管紧张素系统相比。

方法

我们在 4 个地点招募因 ADHF 和射血分数降低而住院的患者;患者分为沙库巴曲缬沙坦组或血管紧张素转换酶抑制剂(ACEI)/血管紧张素受体阻滞剂(ARB)组。所有患者在出院后 3 个月内进行随访。主要终点是心血管原因死亡和心力衰竭再住院的复合结局。

结果

共纳入 251 例接受沙库巴曲缬沙坦治疗和 251 例接受 ACEI/ARB 治疗的患者,两组患者的倾向评分相似,并进行了比较。沙库巴曲缬沙坦组有 40 例(15.9%)患者达到主要终点,ACEI/ARB 组有 59 例(23.5%)患者达到主要终点(HR,0.650;95%CI:0.435-0.971;p=0.035)。沙库巴曲缬沙坦组 72.1%的患者心功能 NYHA 分级改善,ACEI/ARB 组 59.8%的患者心功能 NYHA 分级改善(HR,1.303;95%CI:1.097-1.548,p=0.004)。关键安全性结局指标无显著差异。

结论

在因 ADHF 和左心室射血分数降低而住院的患者中,与单独使用 ACEI/ARB 治疗相比,我们观察到在脆弱期,沙库巴曲缬沙坦治疗可降低心血管原因死亡和心力衰竭再住院率。我们的结果支持在 ADHF 后脆弱期早期给予沙库巴曲缬沙坦,并改善 NYHA 分级。

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