Effects of Sacubitril/Valsartan According to Natriuretic Peptide Levels in Patients Enrolled in PARADIGM-HF and PARAGON-HF.

IF 10.3 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS JACC. Heart failure Pub Date : 2025-02-27 DOI:10.1016/j.jchf.2024.12.010

Toru Kondo, Pardeep S Jhund, Inder S Anand, Brian L Claggett, Akshay S Desai, Kieran F Docherty, Carolyn S P Lam, Martin P Lefkowitz, Aldo P Maggioni, Felipe A Martinez, Margaret M Redfield, Jean L Rouleau, Dirk J Van Veldhuisen, Faiez Zannad, Michael R Zile, Milton Packer, Scott D Solomon, John J V McMurray

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Abstract

Background: Recent trials of new heart failure (HF) treatments suggest the effect of therapy may vary by N-terminal pro-B type natriuretic peptide (NT-proBNP) level.

Objectives: The authors examined the efficacy of sacubitril/valsartan according to NT-proBNP levels in patients with reduced, mildly reduced, and preserved left ventricular ejection fraction (LVEF) enrolled in PARADIGM-HF (Prospective Comparison of Angiotensin Receptor-Neprilysin Inhibitor with Angiotensin-Converting-Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure Trial) and PARAGON-HF (Prospective Comparison of Angiotensin Receptor-Neprilysin Inhibitor with Angiotensin-Receptor Blockers Global Outcomes in HF with Preserved Ejection Fraction).

Methods: Individual patient data from PARADIGM-HF and PARAGON-HF were pooled and participants were divided into categories defined by quintiles of NT-proBNP level. The primary outcome examined was the composite of HF hospitalization or cardiovascular death.

Results: Among the 13,195 patients enrolled in both trials, 13,142 (99.6%) had a baseline NT-proBNP level measured. The rate of the primary outcome (per 100 person-years) increased with NT-proBNP levels: quintile 1, 5.9 (95% CI: 5.3-6.5); quintile 2, 7.5 (95% CI: 6.9-8.2); quintile 3, 9.0 (95% CI: 8.2-9.7); quintile 4, 12.0 (95% CI: 11.1-12.9); and quintile 5, 20.8 (95% CI: 19.6-22.2). The relative risk reduction in the primary outcome with sacubitril/valsartan was consistent across NT-proBNP levels: the HR in quintile 1 was 0.79 (95% CI: 0.65-0.96); quintile 2, 0.87 (95% CI: 0.72-1.04); quintile 3, 0.79 (95% CI: 0.66-0.93); quintile 4, 0.85 (95% CI: 0.73-0.99); and quintile 5, 0.86 (95% CI: 0.76-0.97; P for interaction = 0.86). The absolute risk reduction was greatest in NT-proBNP quintile 5; the number needed to treat for the primary outcome over the median follow-up of 31 months was 16 in quintile 5 vs 37 in quintile 1.

Conclusions: The relative risk reductions with sacubitril/valsartan were consistent irrespective of NT-proBNP level in HF patients across the range of LVEF. Consequently, the absolute risk reductions were greatest in patients with higher NT-proBNP levels. (PARADIGM-HF; NCT01035255; and PARAGON-HF; NCT01920711).

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背景：最近的新心力衰竭（HF）治疗试验表明，治疗效果可能因 N 端前 B 型钠尿肽（NT-proBNP）水平而异：最近的心力衰竭（HF）新疗法试验表明，治疗效果可能因N端前B型钠尿肽（NT-proBNP）水平而异：作者根据NT-proBNP水平研究了沙库比妥/缬沙坦对左心室射血分数降低、轻度降低和保留左心室射血分数的患者的疗效、目的：作者研究了参加 PARADIGM-HF（血管紧张素受体-奈普利酶抑制剂与血管紧张素转换酶抑制剂的前瞻性比较，以确定对心力衰竭总体死亡率和发病率的影响试验）和 PARAGON-HF（血管紧张素受体-奈普利酶抑制剂与血管紧张素受体阻滞剂在射血分数保留的心力衰竭总体结局中的前瞻性比较）的左心室射血分数（LVEF）降低、轻度降低和保留的患者中，根据 NT-proBNP 水平使用沙库比妥/伐沙坦的疗效。方法：汇总 PARADIGM-HF 和 PARAGON-HF 的患者个体数据，并根据 NT-proBNP 水平的五分位数将参与者分为不同类别。研究的主要结果是心房颤动住院或心血管死亡的复合结果：在两项试验的 13 195 名患者中，13 142 人（99.6%）进行了基线 NT-proBNP 水平测定。主要结局发生率（每百人年）随 NT-proBNP 水平的升高而增加：五分位数 1，5.9（95% CI：5.3-6.5）；五分位数 2，7.5（95% CI：6.9-8.2）；五分位数 3，9.0（95% CI：8.2-9.7）；五分位数 4，12.0（95% CI：11.1-12.9）；五分位数 5，20.8（95% CI：19.6-22.2）。不同 NT-proBNP 水平下，使用沙库比妥/缬沙坦治疗主要结局的相对风险降低是一致的：五分位数 1 的 HR 为 0.79（95% CI：0.65-0.96）；五分位数 2 为 0.87（95% CI：0.72-1.04）；五分位数 3，0.79（95% CI：0.66-0.93）；五分位数 4，0.85（95% CI：0.73-0.99）；五分位数 5，0.86（95% CI：0.76-0.97；交互作用 P = 0.86）。NT-proBNP五分位数5的绝对风险降低幅度最大；在31个月的中位随访期间，五分位数5与五分位数1相比，主要结局的治疗需要人数分别为16人和37人：在 LVEF 范围内，无论 HF 患者的 NT-proBNP 水平如何，使用沙库比妥/缬沙坦均可降低相对风险。因此，NT-proBNP 水平较高的患者的绝对风险降低幅度最大。(PARADIGM-HF；NCT01035255；PARAGON-HF；NCT01920711）。

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来源期刊

JACC. Heart failure CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

21.20

自引率

2.30%

发文量

164

期刊介绍： JACC: Heart Failure publishes crucial findings on the pathophysiology, diagnosis, treatment, and care of heart failure patients. The goal is to enhance understanding through timely scientific communication on disease, clinical trials, outcomes, and therapeutic advances. The Journal fosters interdisciplinary connections with neuroscience, pulmonary medicine, nephrology, electrophysiology, and surgery related to heart failure. It also covers articles on pharmacogenetics, biomarkers, and metabolomics.