Objectives

This study sought to better understand the discrepant results of 2 trials of serelaxin on acute heart failure (AHF) and short-term mortality after AHF by analyzing causes of death of patients in the RELAX-AHF-2 (Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF-2) trial.

Background

Patients with AHF continue to suffer significant short-term mortality, but limited systematic analyses of causes of death in this patient population are available.

Methods

Adjudicated cause of death of patients in RELAX-AHF-2, a randomized, double-blind, placebo-controlled trial of serelaxin in patients with AHF across the spectrum of ejection fraction (EF), was analyzed.

Results

By 180 days of follow-up, 11.5% of patients in RELAX-AHF-2 died, primarily due to heart failure (HF) (38% of all deaths). Unlike RELAX-AHF, there was no apparent effect of treatment with serelaxin on any category of cause of death. Older patients (≥75 years) had higher rates of mortality (14.2% vs. 8.8%) and noncardiovascular (CV) death (27% vs. 19%) compared to younger patients. Patients with preserved EF (≥50%) had lower rates of HF-related mortality (30% vs. 40%) but higher non-CV mortality (36% vs. 20%) compared to patients with reduced EF.

Conclusions

Despite previous data suggesting benefit of serelaxin in AHF, treatment with serelaxin was not found to improve overall mortality or have an effect on any category of cause of death in RELAX-AHF-2. Careful adjudication of events in the serelaxin trials showed that older patients and those with preserved EF had fewer deaths from HF or sudden death and more deaths from other CV causes and from noncardiac causes. (Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF [RELAX-AHF-2]; NCT01870778)

中文翻译：

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急性心力衰竭患者的死因

目标

本研究旨在通过分析 RELAX-AHF-2（Serelax 的有效性、安全性和耐受性）中患者的死亡原因，更好地了解 2在 AHF-2) 试验中加入标准治疗时。

背景

AHF 患者继续遭受显着的短期死亡率，但对该患者群体的死因进行有限的系统分析。

方法

RELAX-AHF-2 是一项随机、双盲、安慰剂对照试验，对射血分数 (EF) 范围内的 AHF 患者使用 serelax 进行随机、双盲、安慰剂对照试验，对患者的判定死因进行了分析。

结果

通过 180 天的随访，RELAX-AHF-2 中 11.5% 的患者死亡，主要是由于心力衰竭 (HF)（占所有死亡人数的 38%）。与 RELAX-AHF 不同，serelaxin 治疗对任何类别的死因都没有明显影响。与年轻患者相比，老年患者（≥75 岁）的死亡率（14.2% 对 8.8%）和非心血管（CV）死亡率（27% 对 19%）更高。与 EF 降低的患者相比，EF 保持不变（≥50%）的患者与 HF 相关的死亡率较低（30% 对 40%），但非心血管死亡率（36% 对 20%）较高。

结论

尽管之前的数据表明 serelaxin 对 AHF 有益，但在 RELAX-AHF-2 中，未发现用 serelaxin 治疗可改善总体死亡率或对任何类别的死因有影响。serelaxin 试验中对事件的仔细裁决表明，老年患者和 EF 保留的患者因 HF 或猝死而死亡的人数较少，而因其他心血管原因和非心脏原因导致的死亡人数较多。（将 Serelaxin 添加到 AHF 标准治疗中时的疗效、安全性和耐受性 [RELAX-AHF-2]；NCT01870778）