沙库巴曲缬沙坦在心力衰竭患者肾功能损害谱中的作用。
Effects of Sacubitril/Valsartan Across the Spectrum of Renal Impairment in Patients With Heart Failure.
机构信息
Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA. Electronic address: https://twitter.com/safchat.
Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
出版信息
J Am Coll Cardiol. 2024 Jun 4;83(22):2148-2159. doi: 10.1016/j.jacc.2024.03.392. Epub 2024 Apr 6.
BACKGROUND
The Kidney Disease Improving Global Outcomes (KDIGO) classification integrates both estimated glomerular filtration rate and urine-albumin-creatinine ratio to stratify risk more comprehensively in patients with chronic kidney disease. There are limited data assessing whether this classification system is associated with prognosis and treatment response in heart failure populations.
OBJECTIVES
The aim of this study was to evaluate the relative treatment effects of sacubitril/valsartan across the KDIGO risk categories in patients with HFrEF.
METHODS
PARADIGM-HF (Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) was a global randomized controlled trial evaluating sacubitril/valsartan vs enalapril in patients with heart failure with reduced ejection fraction (HFrEF). Patients were classified according to low, moderate, and high/very high KDIGO risk. Treatment responses were assessed according to baseline KDIGO risk. The primary outcome was a composite of cardiovascular (CV) death or heart failure hospitalization. A renal composite outcome was defined as sustained decline in estimated glomerular filtration rate by ≥40% or end-stage kidney disease.
RESULTS
Among 1,910 (23% of total) participants with available data, 42%, 32%, and 26% were classified as low, moderate, and high/very high KDIGO risk, respectively. Patients in the highest KDIGO risk categories experienced the highest rates of the primary composite outcome (7.6 per 100 person-years [95% CI: 6.5-9.0 per 100 person-years], 9.4 per 100 person-years [95% CI: 7.9-11.2 per 100 person-years], and 14.9 per 100 person-years [95% CI: 12.7-17.6 per 100 person-years]; P < 0.001). Sacubitril/valsartan had a similar safety profile and demonstrated consistent effects on the risk of both the primary outcome (P = 0.31) and the renal composite outcome (P = 0.50) across the spectrum of KDIGO risk.
CONCLUSIONS
One in 4 patients with HFrEF were classified as at least high KDIGO kidney risk; these individuals faced concordantly the highest risks of CV events. Sacubitril/valsartan exhibited consistent CV and kidney protective benefits as well as safety across the spectrum of baseline kidney risk. These data further support initiation of sacubitril/valsartan in HFrEF across a broad range of kidney risk. (This Study Will Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality of Patients With Chronic Heart Failure [PARADIGM-HF]; NCT01035255).
背景
肾脏疾病改善全球结果组织（KDIGO）分类将估计肾小球滤过率和尿白蛋白/肌酐比值相结合，更全面地对慢性肾脏病患者进行风险分层。在心力衰竭患者中，评估该分类系统与预后和治疗反应的相关数据有限。
目的
本研究旨在评估沙库巴曲缬沙坦在射血分数降低的心力衰竭（HFrEF）患者中，根据 KDIGO 风险类别，治疗效果的相对差异。
方法
PARADIGM-HF（沙库巴曲缬沙坦与血管紧张素转换酶抑制剂在射血分数降低的心力衰竭中的比较，以评估对全球死亡率和发病率的影响）是一项全球性随机对照试验，评估了沙库巴曲缬沙坦与依那普利在射血分数降低的心力衰竭（HFrEF）患者中的疗效。根据低、中、高/极高 KDIGO 风险对患者进行分类。根据基线 KDIGO 风险评估治疗反应。主要终点是心血管（CV）死亡或心力衰竭住院的复合终点。肾脏复合终点定义为估计肾小球滤过率持续下降≥40%或终末期肾病。
结果
在 1910 名（占总人数的 23%）有可用数据的参与者中，分别有 42%、32%和 26%的患者被归类为低、中、高/极高 KDIGO 风险。在 KDIGO 风险最高的类别中，患者发生主要复合终点的比例最高（每 100 人年 7.6 例[95%CI：每 100 人年 6.5-9.0 例]、每 100 人年 9.4 例[95%CI：每 100 人年 7.9-11.2 例]和每 100 人年 14.9 例[95%CI：每 100 人年 12.7-17.6 例]；P<0.001）。沙库巴曲缬沙坦具有相似的安全性，在主要结局（P=0.31）和肾脏复合结局（P=0.50）方面，均表现出一致的治疗效果，贯穿 KDIGO 风险谱。
结论
在 HFrEF 患者中，每 4 名患者中就有 1 名被归类为至少高 KDIGO 肾脏风险；这些患者面临着 CV 事件的最高风险。沙库巴曲缬沙坦在整个基线肾脏风险谱中，均表现出一致的 CV 和肾脏保护益处以及安全性。这些数据进一步支持在广泛的肾脏风险范围内，对 HFrEF 患者启用沙库巴曲缬沙坦。（该研究将评估 LCZ696 与依那普利相比在慢性心力衰竭患者中的疗效和安全性 [PARADIGM-HF]；NCT01035255）。
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