Mode of Death in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction: The FINEARTS-HF Randomized Clinical Trial.

Background

To evaluate the mode of death according to EF and the treatment effect of finerenone on cause-specific mortality in patients with HFmrEF/HFpEF.

评估根据射血分数（EF）的死亡模式以及finerenone对HFmrEF/HFpEF患者原因特异性死亡率的治疗效果。

DESIGN, SETTING, AND PARTICIPANTS: This was a prespecified secondary analysis of the Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients With Heart Failure (FINEARTS-HF) randomized clinical trial, which evaluated clinical outcomes in 6001 patients with HF and EF greater than or equal to 40% randomly assigned to finerenone or placebo.

这是对Finerenone试验以研究其在心力衰竭患者中疗效和安全性优于安慰剂（FINEARTS-HF）随机临床试验的预先设定的次要分析，该试验评估了6001名EF大于或等于40%的心力衰竭患者随机分配到finerenone或安慰剂后的临床结果。

The mode of death in relation to baseline EF categories (<50%, ≥50-<60%, and ≥60%) was examined, and the effect of randomized treatment on cause-specific death in Cox regression models was assessed.

研究了与基线EF类别（<50%，≥50-<60%，和≥60%）相关的死亡方式，并在Cox回归模型中评估了随机治疗对特定原因死亡的影响。

Data analysis was conducted between September 2024 and January 2025.

数据分析于2024年9月至2025年1月期间进行。

Methods

Finerenone vs placebo.

非奈利酮与安慰剂的比较。

main_outcomes_and_measures

Mode of death as centrally adjudicated by a clinical end points committee.

死亡方式由临床终点委员会中心判定。

Results

Of 1013 patients (16.9%; median [IQR] age, 76 [69-82] years; 594 male [58.6%]) who died during median (IQR) follow-up of 32 (23-36) months, mode of death was ascribed to cardiovascular causes in 502 (49.6%), noncardiovascular causes in 368 (36.3%), and undetermined cause in 143 (14.1%).

在中位随访期为32（23-36）个月的1013名患者中（占16.9%；中位年龄[四分位数间距]为76[69-82]岁；594名为男性[58.6%]），有502名（49.6%）患者的死亡原因归因于心血管原因，368名（36.3%）患者的死亡原因归因于非心血管原因，143名（14.1%）患者的死亡原因未确定。

Of cardiovascular deaths, 215 (42.8%) were due to sudden death, 163 (32.4%) to HF, 48 (9.6%) to stroke, 25 (5.0%) to myocardial infarction, and 51 (10.2%) to other cardiovascular causes.

在心血管死亡中，215例（42.8%）是由于猝死，163例（32.4%）是由于心力衰竭，48例（9.6%）是由于中风，25例（5.0%）是由于心肌梗死，以及51例（10.2%）是由于其他心血管原因。

The proportion of all-cause, cardiovascular, and sudden death was higher in those with EF less than 50%.

在射血分数小于50%的人群中，全因死亡、心血管死亡和猝死的比例更高。

The proportion of deaths related to HF was similar across EF categories, and the proportion of deaths due to myocardial infarction, stroke, and other cardiovascular causes was low regardless of EF.

与射血分数（EF）类别无关，心力衰竭（HF）相关的死亡比例相似，而因心肌梗死、中风和其他心血管原因导致的死亡比例无论EF如何都较低。

Randomization to finerenone did not significantly reduce death or cause-specific death compared with placebo in any EF category.

与安慰剂相比，随机分配到finerenone治疗在任何EF类别中均未显著降低死亡或特定原因的死亡。

conclusions_and_relevance

Among patients with HFmrEF/HFpEF in the FINEARTS-HF randomized clinical trial, higher proportions of cardiovascular and overall mortality in those with EF less than 50% were related principally to higher proportions of sudden death.

在FINEARTS-HF随机临床试验中，与射血分数大于等于50%的患者相比，射血分数小于50%的患者心血管和总死亡率较高，这主要与突发死亡比例较高有关。

A clear treatment effect of finerenone on cardiovascular or cause-specific mortality was not identified, although the trial was likely underpowered for these outcomes.

尽管该试验可能对这些结果的统计功效不足，但并未明确发现finerenone对心血管或特定原因死亡的治疗效果。

trial_registration

ClinicalTrials.gov Identifier: NCT04435626.

临床试验注册号：NCT04435626。