EMPEROR-Preserved Risk Model and Outcomes in the FINEARTS-HF Trial: A Prespecified Secondary Analysis of FINEARTS-HF.

Background

To evaluate the performance of biomarker-driven prognostic models derived from the Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Preserved Ejection Fraction (EMPEROR-Preserved) Trial in the Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients With Heart Failure (FINEARTS-HF) and to examine whether baseline risk modified the therapeutic effect of finerenone.

评估基于生物标志物的预后模型在Finerenone试验中的表现，该试验旨在研究慢性心力衰竭患者中Empagliflozin的疗效（EMPEROR-Preserved试验），并检查基线风险是否改变了Finerenone的治疗效果。

DESIGN, SETTING, AND PARTICIPANTS: This is a prespecified secondary analysis of the FINEARTS-HF trial, which was conducted across 653 sites in 37 countries among adults aged 40 years and older with symptomatic HF and left ventricular EF (LVEF) of 40% or greater.

设计、设置和参与者：这是FINEARTS-HF试验的预定次要分析，该试验在37个国家的653个地点进行，对象为40岁及以上的成年患者，他们患有有症状的心力衰竭和左心室射血分数（LVEF）为40%或以上。

Patients were randomized between September 2020 and January 2023, and data analysis for this study was conducted from September to October 2025.

患者在2020年9月至2023年1月之间进行了随机分组，而本研究的数据分析则是在2025年9月至10月进行的。

The median (IQR) follow-up period was 32 (23-37) months.

中位随访期为32（23-37）个月。

intervention

Finerenone (titrated to 20 mg or 40 mg) or placebo.

芬乐酮（调整剂量至20毫克或40毫克）或安慰剂。

main_outcomes_and_measures

EMPEROR-Preserved risk scores for the outcomes of first HF hospitalization or cardiovascular death, cardiovascular death, and all-cause death were calculated in FINEARTS-HF using models incorporating N-terminal pro-B-type natriuretic peptide, high-sensitivity cardiac troponin T, New York Heart Association functional class, history of chronic obstructive pulmonary disease and diabetes, insulin use, and-depending on outcome-age, hemoglobin and albumin levels, HF duration, time from prior HF hospitalization, and sodium-glucose transporter 2 inhibitor use.

EMPEROR-Preserved 研究中，首次心力衰竭住院或心血管死亡、心血管死亡和全因死亡的结果风险评分是通过使用包含N末端前体脑钠肽、高敏心肌肌钙蛋白T、纽约心脏协会功能分级、慢性阻塞性肺疾病和糖尿病病史、胰岛素使用情况以及（根据结果）年龄、血红蛋白和白蛋白水平、心力衰竭持续时间、从上次心力衰竭住院以来的时间和钠-葡萄糖共转运蛋白2抑制剂使用情况的模型计算得出的。

Estimated risks were compared with observed event rates, and model performance was assessed using Harrell C statistic.

估计的风险与观察到的事件率进行了比较，模型性能使用Harrell C统计量进行了评估。

Treatment effects were evaluated across risk quintiles (Q1 to Q5) and across the continuous risk distribution.

治疗效果在风险五分位数（Q1至Q5）和连续风险分布中进行了评估。

Results

Among 6001 patients (mean [SD] age, 72.0 [9.6] years; 2732 [45.5%] women; 3003 randomized to finerenone and 2998 randomized to placebo), the EMPEROR-Preserved risk model estimated risk of outcomes, with Q5 vs Q1 hazard ratios (HRs) of 10.49 (95% CI, 8.14-13.52) for the composite of HF hospitalization or cardiovascular death and 13.47 (95% CI, 8.79-20.64) for cardiovascular death.

在6001名患者（平均[标准差]年龄，72.0[9.6]岁；2732[45.5%]女性；3003名随机接受finerenone治疗，2998名随机接受安慰剂）中，EMPEROR-Preserved风险模型估计了结果的风险，Q5与Q1的风险比（HRs）为心力衰竭住院或心血管死亡的复合终点为10.49（95%置信区间，8.14-13.52），心血管死亡为13.47（95%置信区间，8.79-20.64）。

The model demonstrated good discrimination.

该模型显示出良好的区分能力。

The treatment effect of finerenone was consistent across risk quintiles for first HF hospitalization or cardiovascular death (Q1: HR, 0.93 [95% CI, 0.58-1.49]; Q2: HR, 1.04 [95% CI, 0.76-1.43]; Q3: HR, 0.82 [95% CI, 0.62-1.07]; Q4: HR, 0.81 [95% CI, 0.65-1.01]; and Q5: HR, 0.88 [95% CI, 0.74-1.05]; P for interaction = .68) and remained uniform across the continuous risk spectrum.

非奈利酮的治疗效果在首次心力衰竭住院或心血管死亡风险五分位数中是一致的（Q1: HR, 0.93 [95% CI, 0.58-1.49]; Q2: HR, 1.04 [95% CI, 0.76-1.43]; Q3: HR, 0.82 [95% CI, 0.62-1.07]; Q4: HR, 0.81 [95% CI, 0.65-1.01]; 和 Q5: HR, 0.88 [95% CI, 0.74-1.05]; 交互作用P值 = .68），并且在连续风险谱中保持一致。

conclusions_and_relevance

The EMPEROR-Preserved risk models demonstrated good performance in FINEARTS-HF.

EMPEROR-Preserved风险模型在FINEARTS-HF研究中表现出良好的性能。

Baseline risk did not modify the relative treatment effect of finerenone.

基线风险并未改变finerenone的相对治疗效果。

trial_registration

ClinicalTrials.gov Identifier: NCT04435626.

临床试验注册号：NCT04435626。