Maastricht University Medical Center, Maastricht, the Netherlands.
J Am Coll Cardiol. 2010 Dec 14;56(25):2090-100. doi: 10.1016/j.jacc.2010.07.030.
The purpose of this study was to assess whether management of heart failure (HF) guided by an individualized N-terminal pro-B-type natriuretic peptide (NT-proBNP) target would lead to improved outcome compared with HF management guided by clinical assessment alone.
Natriuretic peptides may be attractive biomarkers to guide management of heart failure (HF) and help select patients in need of more aggressive therapy. The PRIMA (Can PRo-brain-natriuretic peptide guided therapy of chronic heart failure IMprove heart fAilure morbidity and mortality?) study is, to our knowledge, the first large, prospective randomized study to address whether management of HF guided by an individualized target NT-proBNP level improves outcome.
A total of 345 patients hospitalized for decompensated, symptomatic HF with elevated NT-proBNP levels at admission were included. After discharge, patients were randomized to either clinically-guided outpatient management (n = 171), or management guided by an individually set NT-proBNP (n = 174) defined by the lowest level at discharge or 2 weeks thereafter. The primary end point was defined as number of days alive outside the hospital after index admission.
HF management guided by this individualized NT-proBNP target increased the use of HF medication (p = 0.006), and 64% of HF-related events were preceded by an increase in NT-proBNP. Nevertheless, HF management guided by this individualized NT-proBNP target did not significantly improve the primary end point (685 vs. 664 days, p = 0.49), nor did it significantly improve any of the secondary end points. In the NT-proBNP-guided group mortality was lower, as 46 patients died (26.5%) versus 57 (33.3%) in the clinically-guided group, but this was not statistically significant (p = 0.206).
Serial NT-proBNP measurement and targeting to an individual NT-proBNP value did result in advanced detection of HF-related events and importantly influenced HF-therapy, but failed to provide significant clinical improvement in terms of mortality and morbidity. (Effect of NT-proBNP Guided Treatment of Chronic Heart Failure [PRIMA]; NCT00149422).
本研究旨在评估与仅根据临床评估进行心力衰竭（HF）管理相比，通过个体化 N 末端脑利钠肽前体（NT-proBNP）目标进行 HF 管理是否会改善结局。
利钠肽可能是指导心力衰竭（HF）管理的有吸引力的生物标志物，并有助于选择需要更积极治疗的患者。据我们所知，PRIMA（Can PRo-brain-natriuretic peptide guided therapy of chronic heart failure IMprove heart fAilure morbidity and mortality？）研究是第一项大型前瞻性随机研究，旨在确定通过个体化 NT-proBNP 水平指导 HF 管理是否改善结局。
共纳入 345 例因失代偿性、症状性 HF 入院且入院时 NT-proBNP 水平升高的患者。出院后，患者被随机分配至接受临床指导的门诊管理（n = 171）或通过个体设定的 NT-proBNP 进行管理（n = 174），出院时或之后 2 周的最低水平定义为 NT-proBNP。主要终点定义为指数入院后存活于院外的天数。
HF 管理以这种个体化的 NT-proBNP 目标为指导，增加了 HF 药物的使用（p = 0.006），并且 64%的 HF 相关事件之前 NT-proBNP 增加。然而，以这种个体化的 NT-proBNP 目标指导 HF 管理并没有显著改善主要终点（685 天 vs. 664 天，p = 0.49），也没有显著改善任何次要终点。在 NT-proBNP 指导组，死亡率较低，46 例死亡（26.5%），而临床指导组 57 例死亡（33.3%），但无统计学意义（p = 0.206）。
连续 NT-proBNP 测量并靶向个体化 NT-proBNP 值确实导致 HF 相关事件的早期检测，并重要地影响 HF 治疗，但在死亡率和发病率方面未能提供显著的临床改善。（NT-proBNP 指导的慢性心力衰竭治疗效果[PRIMA]；NCT00149422）。
