Finerenone According to Frailty in Heart Failure: A Prespecified Analysis of the FINEARTS-HF Randomized Clinical Trial.

Background

To examine the efficacy and safety of finerenone, compared with placebo, according to frailty status in patients with heart failure (HF) and mildly reduced ejection fraction (HFmrEF) or with HF and preserved ejection fraction (HFpEF).

为了检查非奈利酮与安慰剂相比，在虚弱状态的心力衰竭（HF）和轻度射血分数降低（HFmrEF）患者，或心力衰竭和射血分数保留（HFpEF）患者中的疗效和安全性。

DESIGN, SETTING, AND PARTICIPANTS: This was a prespecified secondary analysis of a phase 3 randomized clinical trial, the Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients With Heart Failure (FINEARTS-HF), conducted across 653 sites in 37 countries.

设计、环境和参与者：这是Finerenone试验的预先指定的次要分析，这是一个3期随机临床试验，旨在研究Finerenone在心力衰竭患者中与安慰剂相比的有效性和安全性（FINEARTS-HF），在37个国家的653个地点进行。

Patients with HF with New York Heart Association functional class II through IV, a left ventricular ejection fraction of 40% or higher, evidence of structural heart disease, and elevated natriuretic peptide levels were randomized between September 2020 and January 2023.

在2020年9月至2023年1月期间，对纽约心脏协会功能II至IV级的心力衰竭患者进行了随机分组，这些患者的左心室射血分数为40%或更高，有结构性心脏病的证据，并且利钠肽水平升高。

Data analysis was conducted from October 1 to November 30, 2024.

数据分析从2024年10月1日进行至11月30日。

intervention

Addition of once-daily finerenone or placebo to usual therapy.

将每日一次的非奈利酮或安慰剂添加到常规治疗中。

main_outcomes_and_measures

The primary outcome was a composite of cardiovascular death and total worsening HF events.

主要结果是心血管死亡和总恶化心力衰竭事件的复合终点。

Frailty was measured using the Rockwood cumulative deficit approach.

使用Rockwood累积缺陷方法测量虚弱。

Results

Of the 6001 patients randomized in FINEARTS-HF, a frailty index (FI) was calculable in 5952 patients (mean [SD] age, 72.0 [9.6] years; 3241 [54.4%] male).

在FINEARTS-HF研究中随机分组的6001名患者中，有5952名患者的衰弱指数（FI）可以计算（平均年龄[标准差]，72.0[9.6]岁；3241名[54.4%]为男性）。

In total, 1588 patients (26.7%) had class I frailty (FI ≤0.210 [not frail]), 2141 (36.0%) had class II frailty (FI 0.211-0.310 [more frail]), and 2223 (37.3%) had class III frailty (FI ≥0.311 [most frail]).

总共1588名患者（26.7%）具有I级衰弱（FI ≤0.210 [不衰弱]），2141名（36.0%）具有II级衰弱（FI 0.211-0.310 [更衰弱]），以及2223名（37.3%）具有III级衰弱（FI ≥0.311 [最衰弱]）。

Compared with patients with class I frailty, those with class II and III frailty had a higher risk of the primary outcome (unadjusted rate ratio [RR], 1.88 [95% CI, 1.54-2.28] for class II and 3.86 [95% CI, 3.22-4.64] for class III).

与 I 级虚弱患者相比，II 级和 III 级虚弱患者的首要结果风险更高（未调整的率比[RR]，II 级为 1.88 [95% 置信区间, 1.54-2.28]，III 级为 3.86 [95% 置信区间, 3.22-4.64]）。

The effect of finerenone on the primary outcome did not vary significantly by frailty class (class I: RR, 1.07 [95% CI, 0.77-1.49]; class II: RR, 0.66 [95% CI, 0.52-0.83]; class III: RR, 0.91 [95% CI, 0.76-1.07]; P for interaction = .77).

非奈利酮对首要结果的影响在虚弱等级间没有显著差异（I 级：RR，1.07 [95% 置信区间, 0.77-1.49]；II 级：RR，0.66 [95% 置信区间, 0.52-0.83]；III 级：RR，0.91 [95% 置信区间, 0.76-1.07]；交互作用 P 值 = .77）。

Frailty class did not modify the effects of finerenone on the components of the primary outcome, all-cause death, or improvement in the Kansas City Cardiomyopathy Questionnaire total symptom score.

虚弱等级并未改变finerenone对主要结果组成部分、全因死亡或堪萨斯城心肌病问卷总症状评分改善的影响。

The effects of finerenone, compared with placebo, on experiencing hypotension, elevated creatinine level, hyperkalemia, or hypokalemia did not differ by frailty class.

与安慰剂相比，虚弱等级并未改变finerenone对经历低血压、血清肌酐升高、高钾血症或低钾血症的影响。

conclusions_and_relevance

In FINEARTS-HF, finerenone reduced the risk of total worsening HF events and cardiovascular death, and it improved symptoms; these effects were not modified by frailty status.

在FINEARTS-HF研究中，非奈利酮降低了心力衰竭加重事件和心血管死亡的总风险，并改善了症状；这些效果不受虚弱状态的影响。

In addition, the effects of finerenone on experiencing hypotension, elevated creatinine level, hyperkalemia, or hypokalemia did not differ by frailty status.

此外，非奈利酮导致低血压、血清肌酐水平升高、高钾血症或低钾血症的发生效果在虚弱状态之间没有差异。

trial_registration

ClinicalTrials.gov Identifier: NCT04435626.

临床试验注册号：NCT04435626。