Spironolactone in Patients With Heart Failure, Preserved Ejection Fraction, and Worsening Renal Function
Spironolactone in Patients With Heart Failure, Preserved Ejection Fraction, and Worsening Renal Function
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DOI：
10.1016/j.jacc.2020.12.057
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发表时间：
2021-03-01
影响因子：
24
通讯作者：
Desai, Akshay S.
中科院分区：
文献类型：
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作者：
Beldhuis, Iris E.;Myhre, Peder L.;Desai, Akshay S.
用螺内酯治疗射血分数保留性心力衰竭（HFpEF）与心力衰竭住院（HFH）风险降低相关，但肾功能恶化（WRF）风险增加。本研究的目的是调查HFpEF患者WRF、螺内酯治疗和临床结局之间的关系。方法在TOPCAT中随机分配至螺内酯或安慰剂组的1，767例患者中，（用醛固酮拮抗剂治疗保留心功能的心力衰竭试验）-美洲研究，我们通过治疗分配检查了WRF（血清肌酐加倍）的发生率。根据治疗分配，事件WRF与主要研究终点心血管（CV）死亡、HFH或心脏骤停流产的后续风险和关键次要结局（包括CV死亡、HFH和全因死亡率）之间的相关性，在含交互作用项的时间更新考克斯比例风险模型中进行检验（14.7%）的患者，与安慰剂组相比，螺内酯组的发生率更高（17.8% vs. 11.6%;比值比：1.66; 95%置信区间：1.27至2.17; p < 0.001）。无论治疗如何，在多变量调整后，WRF事件与主要终点的风险增加相关（风险比：2.04; 95%置信区间：1.52至2.72; p < 0.001）。尽管治疗分配和WRF之间在主要终点方面没有统计学相互作用，（相互作用p = 0.11），螺内酯相关WRF与CV死亡风险降低相关（相互作用p = 0.003）和全因死亡率（相互作用p = 0.001）与安慰剂相关WRF相比。与安慰剂相比，安体舒通增加了WRF的风险。在有和无WRF的患者中，螺内酯组的CV死亡率均较低。(c)2021年美国心脏病学会基金会。由Elsevier出版。All rights reserved.
BACKGROUND Treatment of heart failure with preserved ejection fraction (HFpEF) with spironolactone is associated with lower risk of heart failure hospitalization (HFH) but increased risk of worsening renal function (WRF). The prognostic implications of spironolactone-associated WRF in HFpEF patients are not well understood.OBJECTIVES The purpose of this study was to investigate the association between WRF, spironolactone treatment, and clinical outcomes in patients with HFpEF.METHODS In 1,767 patients randomized to spironolactone or placebo in the TOPCAT (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist Trial)-Americas study, we examined the incidence of WRF (doubling of serum creatinine) by treatment assignment. Associations between incident WRF and subsequent risk for the primary study endpoint of cardiovascular (CV) death, HFH, or aborted cardiac arrest and key secondary outcomes, including CV death, HFH, and all-cause mortality according to treatment assignment, were examined in time-updated Cox proportional hazards models with an interaction term.RESULTS WRF developed in 260 (14.7%) patients with higher rates in those assigned to spironolactone compared to placebo (17.8% vs. 11.6%; odds ratio: 1.66; 95% confidence interval: 1.27 to 2.17; p < 0.001). Regardless of treatment, incident WRF was associated with increased risk for the primary endpoint (hazard ratio: 2.04; 95% confidence interval: 1.52 to 2.72; p < 0.001) after multivariable adjustment. Although there was no statistical interaction between treatment assignment and WRF regarding the primary endpoint (interaction p = 0.11), spironolactone-associated WRF was associated with lower risk of CV death (interaction p = 0.003) and all-cause mortality (interaction p = 0.001) compared with placebo-associated WRF.CONCLUSIONS Among HFpEF patients enrolled in TOPCAT-Americas, spironolactone increased risk of WRF compared with placebo. Rates of CV death were lower with spironolactone in both patients with and without WRF. (c) 2021 the American College of Cardiology Foundation. Published by Elsevier. All rights reserved.