Estimated Long-Term Benefits of Finerenone in Heart Failure: A Prespecified Secondary Analysis of the FINEARTS-HF Randomized Clinical Trial.

The nonsteroidal mineralocorticoid receptor antagonist, finerenone, was recently shown to reduce risks of cardiovascular events in this population over a median follow-up of 2.6 years; as patients with HF typically continue treatment beyond this time frame, estimating the potential long-term benefits of finerenone could inform shared clinical decision-making.

非甾体类盐皮质激素受体拮抗剂finerenone最近被证明在中位随访2.6年期间降低了这一人群心血管事件的风险；由于心力衰竭患者通常会继续治疗超过这个时间范围，估计finerenone的潜在长期益处可以为共享临床决策提供信息。

Background

To estimate the projected long-term treatment effects of finerenone in patients with HF with mildly reduced or preserved ejection fraction if treated over a patient's lifetime.

为了估计在患者一生中接受治疗的情况下，finerenone对轻度降低或保留射血分数的心力衰竭患者的长期治疗效果。

DESIGN, SETTING, AND PARTICIPANTS: Prespecified analyses were conducted of the FINEARTS-HF trial, a phase 3 randomized clinical trial conducted across 653 sites in 37 countries.

设计、环境和参与者：对FINEARTS-HF试验进行了预定分析，这是一项在37个国家的653个地点进行的3期随机临床试验。

Adults 40 years and older with symptomatic HF and left ventricular ejection fraction of 40% or greater were randomized from September 2020 to January 2023.

从2020年9月到2023年1月，随机招募了40岁及以上的有症状心力衰竭患者，且左心室射血分数为40%或以上。

Median (IQR) follow-up was 2.6 (1.9-3.0) years.

中位随访时间（四分位数间距）为2.6（1.9-3.0）年。

Methods

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

给予患者Finerenone（逐渐调整剂量至20毫克或40毫克）或安慰剂。

main_outcomes_and_measures

The primary composite outcome was time to cardiovascular death or worsening HF event.

主要复合终点是心血管死亡或心力衰竭恶化事件的时间。

The long-term gains in survival free from a primary end point with finerenone were iteratively estimated with age-based Kaplan-Meier curves using age at randomization rather than time from randomization.

使用随机化时的年龄而非从随机化开始的时间，通过基于年龄的Kaplan-Meier曲线迭代估计了finerenone在无主要终点事件生存获益的长期收益。

Differences in areas under the survival curves between the finerenone and placebo arms represented event-free survival gains.

finerenone组与安慰剂组生存曲线下的面积差异代表了无事件生存获益。

Results

Among 6001 participants (median [IQR] age, 73 [66-79] years; 3269 male [54.5%]), mean survival free from the primary end point for a 55-year-old participant was 13.6 years (95% CI, 11.9-15.2 years) with finerenone and 10.5 years (95% CI, 6.8-11.3 years) with placebo, representing a gain in event-free survival of 3.1 years (95% CI, 0.8-5.4 years; P = .007).

在6001名参与者中（中位年龄[四分位数间距]为73[66-79]岁；3269名为男性[54.5%]），55岁参与者的平均无主要终点事件生存期为13.6年（95%置信区间，11.9-15.2年）使用finerenone治疗，以及10.5年（95%置信区间，6.8-11.3年）使用安慰剂，代表了无事件生存期增加了3.1年（95%置信区间，0.8-5.4年；P = .007）。

Mean event-free survival for a 65-year-old participant was 11.0 years (95% CI, 10.1-11.9 years) with finerenone and 8.9 years (95% CI, 8.1-9.8 years) with placebo, representing a gain of 2.0 years (95% CI, 0.8-3.3 years; P = .001).

65岁参与者的平均无事件生存期为11.0年（95%置信区间，10.1-11.9年）使用finerenone治疗，以及8.9年（95%置信区间，8.1-9.8年）使用安慰剂，代表了无事件生存期增加了2.0年（95%置信区间，0.8-3.3年；P = .001）。

Projected mean event-free survival was numerically greater with finerenone than with placebo for every starting age between 50 to 80 years.

与安慰剂相比，finerenone在50至80岁每个起始年龄的预计平均无事件生存期数值上都更长。

Lifetime gains in event-free survival were observed even among individuals already treated with a sodium-glucose cotransporter 2 inhibitor (65-year-old participant: 3.1 years; 95% CI, 0.1-6.0 years; P = .04).

即使在已经接受钠-葡萄糖共转运蛋白2抑制剂治疗的个体中，也观察到了无事件生存期的终身获益（65岁参与者：3.1年；95% 置信区间，0.1-6.0年；P = .04）。

conclusions_and_relevance

In this prespecified secondary analysis of the FINEARTS-HF randomized clinical trial, long-term treatment with finerenone was estimated to extend event-free survival by up to 3 years among people with HF with mildly reduced or preserved ejection fraction.

在这项FINEREARTS-HF随机临床试验的事先指定的次要分析中，长期使用finerenone治疗估计可以将心功能轻度降低或保留射血分数的人群的无事件生存期延长至多3年。

trial_registration

ClinicalTrials.gov Identifier: NCT04435626.

ClinicalTrials.gov注册号：NCT04435626。