Finerenone and Atrial Fibrillation in Heart Failure: A Secondary Analysis of the FINEARTS-HF Randomized Clinical Trial.

Background

To examine the efficacy and safety of the nonsteroidal mineralocorticoid receptor antagonist finerenone in patients with HF with mildly reduced or preserved ejection fraction according to the absence or presence of AF and the type of AF (paroxysmal vs persistent or permanent).

为了检查非甾体盐皮质激素受体拮抗剂非诺利酮在伴有轻度降低或保留射血分数的HF患者中的疗效和安全性，根据房颤（AF）的有无以及房颤的类型（阵发性 vs 持续性或永久性）。

DESIGN, SETTING, AND PARTICIPANTS: Prespecified analyses were conducted in the Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients With Heart Failure (FINEARTS-HF) randomized clinical trial. The trial was conducted across 653 sites in 37 countries.

设计、设置和参与者：在Finerenone试验中进行了预先规定的分析，以研究在心力衰竭患者中Finerenone的疗效和安全性优于安慰剂的随机临床试验（FINEARTS-HF）。该试验在37个国家的653个地点进行。

Participants were adults aged 40 years and older with symptomatic HF and left ventricular ejection fraction 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，有症状的心力衰竭和左心室射血分数为40%或以上，于2020年9月至2023年1月之间进行随机分组。

Data analysis was conducted from September 1 to October 1, 2024.

数据分析工作于2024年9月1日至10月1日进行。

intervention

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

使用20毫克或40毫克剂量调整的非诺贝特或安慰剂。

main_outcomes_and_measures

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

主要结果是心力衰竭事件和心血管死亡的复合终点。

New-onset AF or atrial flutter (AFL) was a prespecified exploratory outcome.

新发房颤或房扑（AFL）是一个预先设定的探索性结果。

Results

Among 5984 patients (mean [SD] age, 72.0 [9.6] years; 2724 [45.5%] female) with known AF status at baseline, 1384 (23.1%) had paroxysmal AF and 1886 (31.5%) had persistent or permanent AF.

在5984名患者中（平均年龄[标准差]为72.0[9.6]岁；2724名[45.5%]为女性），基线时已知房颤（AF）状态的患者中，有1384名（23.1%）患有阵发性房颤，1886名（31.5%）患有持续性或永久性房颤。

Patients with both types of AF were older and had worse HF status compared with those without AF (2714 patients [45.4%]).

与没有房颤的患者（2714名，占45.4%）相比，两种类型的房颤患者年龄更大，心力衰竭（HF）状况更差。

Both types of AF were associated with a higher unadjusted risk of the primary outcome compared with no AF (event rate per 100 person-years of follow-up, 20.3 [95% CI, 17.9-23.1] with paroxysmal AF, 19.8 [95% CI, 17.8-22.0] with persistent or permanent AF, and 11.9 [95% CI, 10.7-13.3] with no AF; rate ratio [RR], 1.62 [95% CI, 1.37-1.92] with paroxysmal AF and 1.66 [95% CI, 1.43-1.93] with persistent or permanent AF vs no AF); however, the associations were attenuated after adjustment for known prognostic variables.

两种类型的房颤与无房颤相比，未经调整的初级结果风险更高（随访每100人年事件率，阵发性房颤为20.3 [95% CI, 17.9-23.1]，持续性或永久性房颤为19.8 [95% CI, 17.8-22.0]，无房颤为11.9 [95% CI, 10.7-13.3]；风险比[RR]，与无房颤相比，阵发性房颤为1.62 [95% CI, 1.37-1.92]，持续性或永久性房颤为1.66 [95% CI, 1.43-1.93]；然而，在调整已知预后变量后，这些关联减弱。

The benefit of finerenone on the primary outcome (overall RR, 0.84 [95% CI, 0.74-0.95]) was not modified by baseline AF status (RR, 0.80 [95% CI, 0.65-0.98] with no AF, 0.83 [95% CI, 0.65-1.06] with paroxysmal AF, and 0.85 [95% CI, 0.69-1.05] with persistent or permanent AF; P for interaction = .94).

非奈利酮对初级结果的益处（总体RR，0.84 [95% CI, 0.74-0.95]）不受基线房颤状态的影响（无房颤RR为0.80 [95% CI, 0.65-0.98]，阵发性房颤为0.83 [95% CI, 0.65-1.06]，持续性或永久性房颤为0.85 [95% CI, 0.69-1.05]；交互作用P值为.94）。

New-onset AF or AFL occurred in 6.5% of patients and was associated with a higher subsequent adjusted risk of the primary outcome (rate ratio, 3.65 [95% CI, 2.57-5.18]; P < .001).

新发房颤或房扑发生在6.5%的患者中，并与随后调整后的首要结果风险增加有关（比率比，3.65 [95% 置信区间，2.57-5.18]；P < .001）。

The subdistribution hazard ratiofor new-onset AF or AFL among those receiving finerenone vs placebo was 0.77 (95% CI, 0.57-1.04; P = .09).

在接受非奈利酮与安慰剂的患者中，新发房颤或房扑的亚分布风险比为0.77（95% 置信区间，0.57-1.04；P = .09）。

conclusions_and_relevance

The efficacy of finerenone was consistent regardless of AF status.

无论房颤状态如何，非奈利酮的疗效均保持一致。

New-onset AF was associated with a substantially higher risk of subsequent outcomes.

新发房颤与随后结果的显著更高风险相关。

trial_registration

ClinicalTrials.gov Identifier: NCT04435626.

临床试验注册号：NCT04435626。