慢性心力衰竭肺动脉压监测：MONITOR-HF 试验中临床相关亚组的影响。
Pulmonary artery pressure monitoring in chronic heart failure: effects across clinically relevant subgroups in the MONITOR-HF trial.
机构信息
Department of Cardiology, Thorax Centre, Cardiovascular Institute, Erasmus University Medical Center, Dr. Molewaterplein 40, 3015GD Rotterdam, Netherlands.
Department of Cardiology, University Medical Centre Groningen, Groningen, Netherlands.
出版信息
Eur Heart J. 2024 Aug 21;45(32):2954-2964. doi: 10.1093/eurheartj/ehae323.
BACKGROUND AND AIMS
In patients with chronic heart failure (HF), the MONITOR-HF trial demonstrated the efficacy of pulmonary artery (PA)-guided HF therapy over standard of care in improving quality of life and reducing HF hospitalizations and mean PA pressure. This study aimed to evaluate the consistency of these benefits in relation to clinically relevant subgroups.
METHODS
The effect of PA-guided HF therapy was evaluated in the MONITOR-HF trial among predefined subgroups based on age, sex, atrial fibrillation, diabetes mellitus, left ventricular ejection fraction, HF aetiology, cardiac resynchronization therapy, and implantable cardioverter defibrillator. Outcome measures were based upon significance in the main trial and included quality of life-, clinical-, and PA pressure endpoints, and were assessed for each subgroup. Differential effects in relation to the subgroups were assessed with interaction terms. Both unadjusted and multiple testing adjusted interaction terms were presented.
RESULTS
The effects of PA monitoring on quality of life, clinical events, and PA pressure were consistent in the predefined subgroups, without any clinically relevant heterogeneity within or across all endpoint categories (all adjusted interaction P-values were non-significant). In the unadjusted analysis of the primary endpoint quality-of-life change, weak trends towards a less pronounced effect in older patients (Pinteraction = .03; adjusted Pinteraction = .33) and diabetics (Pinteraction = .01; adjusted Pinteraction = .06) were observed. However, these interaction effects did not persist after adjusting for multiple testing.
CONCLUSIONS
This subgroup analysis confirmed the consistent benefits of PA-guided HF therapy observed in the MONITOR-HF trial across clinically relevant subgroups, highlighting its efficacy in improving quality of life, clinical, and PA pressure endpoints in chronic HF patients.
背景与目的
在慢性心力衰竭（HF）患者中，MONITOR-HF 试验表明，肺动脉（PA）指导的 HF 治疗优于标准治疗，可以改善生活质量，减少 HF 住院和平均 PA 压。本研究旨在评估这些益处与临床相关亚组的一致性。
方法
根据年龄、性别、房颤、糖尿病、左心室射血分数、HF 病因、心脏再同步治疗和植入式心脏复律除颤器，在 MONITOR-HF 试验中对 PA 指导的 HF 治疗效果进行了预设亚组评估。根据主要试验的显著性，终点评估包括生活质量、临床和 PA 压力终点，并对每个亚组进行评估。使用交互项评估与亚组相关的差异效应。同时呈现了未调整和多重检验调整的交互项。
结果
PA 监测对生活质量、临床事件和 PA 压的影响在预设亚组中是一致的，在所有终点类别中，没有任何临床相关的异质性（所有调整后的交互 P 值均无显著性）。在对主要终点生活质量变化的未调整分析中，观察到老年患者（Pinteraction =.03；调整后的 Pinteraction =.33）和糖尿病患者（Pinteraction =.01；调整后的 Pinteraction =.06）的效果较弱。然而，这些交互作用在进行多重检验调整后并未持续存在。
结论
本亚组分析证实了 MONITOR-HF 试验中观察到的 PA 指导的 HF 治疗在临床相关亚组中的一致益处，突出了其在改善慢性 HF 患者生活质量、临床和 PA 压力终点方面的疗效。
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