Finerenone for Heart Failure and Risk Estimated by the PREDICT-HFpEF Model: A Secondary Analysis of FINEARTS-HF.

Background

To validate the Prognostic Models for Mortality and Morbidity in HFpEF (PREDICT-HFpEF) in the phase 3 randomized clinical trial Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients With Heart Failure (FINEARTS-HF) and to evaluate the effect of finerenone, compared with placebo, across the spectrum of risk in these patients.

在第三阶段随机临床试验Finerenone试验中，旨在研究Finerenone在心力衰竭患者中疗效和安全性优于安慰剂的FINESSE-HF研究中，验证心力衰竭伴射血分数保留（HFpEF）的死亡和发病率预后模型（PREDICT-HFpEF），并评估finerenone与安慰剂相比，在这些患者的风险谱中的效果。

DESIGN, SETTING, AND PARTICIPANTS: The FINEARTS-HF trial was conducted across 653 sites in 37 countries.

设计、环境和参与者：FINEARTS-HF试验在37个国家的653个地点进行。

Participants were adults 40 years and older with symptomatic HF and left ventricular EF of 40% or greater randomized between September 2020 and January 2023.

参与者为40岁及以上的成年患者，这些患者有症状性心力衰竭和左心室射血分数为40%或更高，他们在2020年9月至2023年1月之间进行了随机分组。

intervention

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

Finerenone（逐渐增加剂量至20毫克或40毫克）或安慰剂。

main_outcomes_and_measures

The 3 PREDICT-HFpEF risk scores for the composite outcome of cardiovascular death or HF hospitalization, cardiovascular death, and all-cause death, respectively, were calculated.

分别计算了PREDICT-HFpEF风险评分对于心血管死亡或心力衰竭住院、心血管死亡和全因死亡的复合结果。

Predicted risk was compared with observed outcomes.

预测风险与观察到的结果进行了比较。

Model performance was assessed using the Harrell C statistic.

使用Harrell C统计量评估了模型性能。

The rates of the predicted outcomes (plus the composite of cardiovascular death and worsening HF events, which was the primary end point in the trial) were examined according to quintiles of risk score, as was the effect of finerenone according to risk quintiles.

根据风险评分的五分位数，检查了预测结果的发生率（以及心血管死亡和恶化心力衰竭事件的复合终点，这是试验的主要终点）以及根据风险五分位数的非奈利酮的效果。

Results

A total of 6001 patients (mean [SD] age, 72 [9.6] years; 3269 male [54.5%]) were randomized in the FINEARTS-HF trial. The C statistics for cardiovascular death or HF hospitalization, cardiovascular death, and all-cause death at 2 years were 0.71 (95% CI, 0.69-0.72), 0.68 (95% CI, 0.66-0.71), and 0.69 (95% CI, 0.67-0.71), respectively.

FINEARTS-HF试验共随机分配了6001名患者（平均[标准差]年龄为72[9.6]岁；3269名男性[54.5%]）。心血管死亡或心力衰竭住院、心血管死亡和全因死亡在2年时的C统计量分别为0.71（95%置信区间，0.69-0.72）、0.68（95%置信区间，0.66-0.71）和0.69（95%置信区间，0.67-0.71）。

The risk of the composite outcomes was approximately 8- to 10-fold higher in those in the highest compared with the lowest risk quintile.

在最高风险五分位数与最低风险五分位数的个体中，复合结果的风险大约高出8到10倍。

The relative risk reduction with finerenone compared with placebo was consistent across the spectrum of risk for all outcomes examined (eg, interaction P value for primary outcome = .24).

与安慰剂相比，使用非诺贝特的相对风险降低在所有考察结果的风险谱中是一致的（例如，主要结果的交互作用P值为0.24）。

conclusions_and_relevance

Results of the FINEARTS-HF randomized clinical trial demonstrate that the PREDICT-HFpEF models performed well in terms of calibration and discrimination.

FINEARTS-HF 随机临床试验的结果显示，PREDICT-HFpEF 模型在定标和鉴别方面表现优秀。

Baseline risk did not modify the benefit of finerenone.

基线风险没有改变非奈利酮的益处。

trial_registration

ClinicalTrials.gov Identifier: NCT04435626.

ClinicalTrials.gov 注册号：NCT04435626。