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瑞马唑仑对急性心力衰竭患者死亡方式的影响:RELAX-AHF 研究结果。

Effect of serelaxin on mode of death in acute heart failure: results from the RELAX-AHF study.

机构信息

Division of Cardiology, Duke University School of Medicine and Duke Heart Center, Durham, North Carolina.

Division of Cardiology, University of California at San Francisco and San Francisco Veterans Affairs Medical Center, San Francisco, California.

出版信息

J Am Coll Cardiol. 2014 Oct 14;64(15):1591-8. doi: 10.1016/j.jacc.2014.05.071.

DOI:10.1016/j.jacc.2014.05.071
PMID:25301463
Abstract

BACKGROUND

Little is known about mode of death after acute heart failure (AHF) hospitalization. In the RELAX-AHF (Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure) study, serelaxin, the recombinant form of human relaxin-2, reduced post-discharge mortality at 180 days in selected patients with AHF.

OBJECTIVES

The goal of this study was to assess the effect of serelaxin on specific modes of death in patients with AHF.

METHODS

The RELAX-AHF study randomized 1,161 patients with AHF to 48 h of therapy with intravenous serelaxin or placebo. Patients were followed for vital status through 180 days. A blinded clinical events committee reviewed all deaths and adjudicated a cause of death on the basis of pre-specified criteria. Cox proportional hazard models were used to assess the effect of serelaxin on each mode of death, on the basis of pre-specified groupings of mode of death.

RESULTS

There were 107 deaths (9.3%): 37 (35%) due to HF, 25 (23%) due to sudden death, 15 (14%) due to other cardiovascular (CV) causes, 19 (18%) due to non-CV causes, and 11 (10%) classified as unknown. The treatment effect of serelaxin was most pronounced on other CV deaths (hazard ratio [HR]: 0.29; 95% CI: 0.12 to 0.73; p = 0.005) and sudden death (HR: 0.46; 95% CI: 0.20 to 1.07; p = 0.065). There was no apparent impact of serelaxin treatment on HF deaths or non-CV deaths.

CONCLUSIONS

In the RELAX-AHF study, the effects of serelaxin on mortality were primarily driven by reduction in mortality from other CV causes and sudden death, without apparent impact on HF deaths. (Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure [RELAX-AHF]; NCT00520806).

摘要

背景

急性心力衰竭(AHF)住院患者的死亡模式知之甚少。在 RELAX-AHF(松弛素治疗急性心力衰竭的疗效和安全性)研究中,重组人松弛素-2 形式的 serelaxin 降低了选定的 AHF 患者出院后 180 天的死亡率。

目的

本研究旨在评估 serelaxin 对 AHF 患者特定死亡模式的影响。

方法

RELAX-AHF 研究将 1161 例 AHF 患者随机分为静脉注射 serelaxin 或安慰剂 48 小时治疗。通过 180 天的生命状态随访评估患者。一个盲法临床事件委员会审查了所有死亡事件,并根据预先指定的标准对死亡原因进行了裁决。使用 Cox 比例风险模型根据预先指定的死亡模式分组评估 serelaxin 对每种死亡模式的影响。

结果

共有 107 例死亡(9.3%):37 例(35%)死于心力衰竭,25 例(23%)死于猝死,15 例(14%)死于其他心血管(CV)原因,19 例(18%)死于非 CV 原因,11 例(10%)死因不明。Serelaxin 的治疗效果在其他 CV 死亡方面最为显著(风险比 [HR]:0.29;95%CI:0.12 至 0.73;p = 0.005)和猝死(HR:0.46;95%CI:0.20 至 1.07;p = 0.065)。Serelaxin 治疗对心力衰竭死亡或非 CV 死亡似乎没有明显影响。

结论

在 RELAX-AHF 研究中,serelaxin 对死亡率的影响主要是通过降低其他 CV 原因和猝死导致的死亡率来实现的,而对心力衰竭死亡没有明显影响。(松弛素治疗急性心力衰竭的疗效和安全性[RELAX-AHF];NCT00520806)。

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