非奈利酮在轻度射血分数降低或保留的心力衰竭射血分数范围内的疗效和安全性：FINEARTS-HF试验的预设分析
Efficacy and Safety of Finerenone Across the Ejection Fraction Spectrum in Heart Failure With Mildly Reduced or Preserved Ejection Fraction: A Prespecified Analysis of the FINEARTS-HF Trial.
作者信息
Docherty Kieran F, Henderson Alasdair D, Jhund Pardeep S, Claggett Brian L, Desai Akshay S, Mueller Katharina, Viswanathan Prabhakar, Scalise Andrea, Lam Carolyn S P, Senni Michele, Shah Sanjiv J, Voors Adriaan A, Zannad Faiez, Pitt Bertram, Vaduganathan Muthiah, Solomon Scott D, McMurray John J V
机构信息
British Heart Foundation Cardiovascular Research Centre, University of Glasgow, UK (K.F.D., A.D.H., P.S.J., J.J.V.M.).
Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (B.L.C., A.S.D., M.V., S.D.S.).
出版信息
Circulation. 2025 Jan 7;151(1):45-58. doi: 10.1161/CIRCULATIONAHA.124.072011. Epub 2024 Sep 29.
BACKGROUND
The effects of treatments for heart failure (HF) may vary among patients according to left ventricular ejection fraction (LVEF). In FINEARTS-HF (Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients With Heart Failure), the nonsteroidal mineralocorticoid receptor antagonist finerenone reduced the risk of cardiovascular death and total worsening HF events in patients with HF with mildly reduced or preserved ejection fraction. We examined the effect of finerenone according to LVEF in FINEARTS-HF.
METHODS
FINEARTS-HF was a randomized, placebo-controlled trial examining the efficacy and safety of finerenone in patients with HF and LVEF ≥40%. The treatment effect of finerenone was examined in prespecified analyses according to LVEF categories (<50%, ≥50% to <60%, and ≥60%) and with LVEF as a continuous variable. The primary outcome was a composite of total (first and recurrent) worsening HF events and cardiovascular death.
RESULTS
Baseline LVEF data were available for 5993 of the 6001 participants in FINEARTS-HF. Mean and median LVEF were 53±8% and 53% (interquartile range, 46%-58%), respectively. LVEF was <50% in 2172 (36%), between 50% and <60% in 2674 (45%), and ≥60% in 1147 (19%). Patients with higher LVEF were older, were more commonly female, were less likely to have a history of coronary artery disease, and more frequently had a history of hypertension and chronic kidney disease compared with those with a lower LVEF. Finerenone reduced the risk of cardiovascular death and total HF events consistently across LVEF categories (LVEF <50% rate ratio, 0.84 [95% CI, 0.68-1.03]; LVEF ≥50% to <60% rate ratio, 0.80 [0.66-0.97]; and LVEF ≥60% rate ratio, 0.94 [0.70-1.25]; =0.70). There was no modification of the benefit of finerenone across the range of LVEF when analyzed as a continuous variable (=0.28). There was a similar consistent effect of finerenone on reducing the total number of worsening HF events (continuous =0.26).
CONCLUSIONS
In patients with HF with mildly reduced or preserved ejection fraction, finerenone reduced the risk of cardiovascular death and worsening HF events, irrespective of LVEF.
REGISTRATION
URL: https://www.clinicaltrials.gov; Unique identifier: NCT04435626. URL: https://eudract.ema.europa.eu; Unique identifier: 2020-000306-29.
背景
心力衰竭（HF）治疗的效果可能因患者的左心室射血分数（LVEF）而异。在FINEARTS-HF（非奈利酮治疗心力衰竭患者疗效和安全性优于安慰剂的试验）中，非甾体类盐皮质激素受体拮抗剂非奈利酮降低了射血分数轻度降低或保留的心力衰竭患者发生心血管死亡和心力衰竭总体恶化事件的风险。我们在FINEARTS-HF中根据LVEF研究了非奈利酮的效果。
方法
FINEARTS-HF是一项随机、安慰剂对照试验，研究非奈利酮在LVEF≥40%的心力衰竭患者中的疗效和安全性。根据LVEF类别（<50%、≥50%至<60%和≥60%）以及将LVEF作为连续变量，在预先设定的分析中研究了非奈利酮的治疗效果。主要结局是心力衰竭总体（首次和复发）恶化事件与心血管死亡的复合结局。
结果
FINEARTS-HF的6001名参与者中有5993人可获得基线LVEF数据。LVEF的均值和中位数分别为53±8%和53%（四分位间距，46%-58%）。LVEF<50%的有2172人（36%），50%至<60%的有2674人（45%），≥60%的有1147人（19%）。与LVEF较低的患者相比，LVEF较高的患者年龄更大，女性更常见，患冠状动脉疾病的可能性更小，患高血压和慢性肾病的频率更高。非奈利酮在各LVEF类别中均持续降低心血管死亡和心力衰竭总体事件的风险（LVEF<50%时的率比为0.84[95%CI，0.68-1.03]；LVEF≥50%至<60%时的率比为0.80[0.66-0.97]；LVEF≥60%时的率比为0.94[0.70-1.25]；P=0.70）。当作为连续变量分析时，在整个LVEF范围内非奈利酮的获益无差异（P=0.28）。非奈利酮在减少心力衰竭恶化事件总数方面有类似的一致效果（连续变量P=0.26）。
结论
在射血分数轻度降低或保留的心力衰竭患者中，无论LVEF如何，非奈利酮均降低了心血管死亡和心力衰竭恶化事件的风险。
注册信息
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