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Pulmonary artery pressure monitoring in chronic heart failure: effects across clinically relevant subgroups in the MONITOR-HF trial
European Heart Journal ( IF 37.6 ) Pub Date : 2024-05-09 , DOI: 10.1093/eurheartj/ehae323 Pascal R D Clephas 1 , Victor W Zwartkruis 2 , Jishnu Malgie 1 , Marco W F van Gent 3 , Hans-Peter Brunner-La Rocca 4 , Mariusz K Szymanski 5 , Vokko P van Halm 6 , M Louis Handoko 5 , Wouter E M Kok 6 , Folkert W Asselbergs 6 , Roland R J van Kimmenade 7 , Olivier C Manintveld 1 , Nicolas M D A van Mieghem 1 , Saskia L M A Beeres 8 , Marco C Post 5, 9 , C Jan Willem Borleffs 10 , Raymond Tukkie 11 , Arend Mosterd 12 , Gerard C M Linssen 13 , Ruud F Spee 14 , Mireille E Emans 15 , Tom D J Smilde 16 , Jan van Ramshorst 17 , Charles J H J Kirchhof 18 , Margriet W Feenema-Aardema 19 , Carlos A da Fonseca 19 , Mieke van den Heuvel 20 , Ronald Hazeleger 21 , Martijn van Eck 22 , Loek van Heerebeek 23 , Eric Boersma 1 , Michiel Rienstra 2 , Rudolf A de Boer 1 , Jasper J Brugts 1
European Heart Journal ( IF 37.6 ) Pub Date : 2024-05-09 , DOI: 10.1093/eurheartj/ehae323 Pascal R D Clephas 1 , Victor W Zwartkruis 2 , Jishnu Malgie 1 , Marco W F van Gent 3 , Hans-Peter Brunner-La Rocca 4 , Mariusz K Szymanski 5 , Vokko P van Halm 6 , M Louis Handoko 5 , Wouter E M Kok 6 , Folkert W Asselbergs 6 , Roland R J van Kimmenade 7 , Olivier C Manintveld 1 , Nicolas M D A van Mieghem 1 , Saskia L M A Beeres 8 , Marco C Post 5, 9 , C Jan Willem Borleffs 10 , Raymond Tukkie 11 , Arend Mosterd 12 , Gerard C M Linssen 13 , Ruud F Spee 14 , Mireille E Emans 15 , Tom D J Smilde 16 , Jan van Ramshorst 17 , Charles J H J Kirchhof 18 , Margriet W Feenema-Aardema 19 , Carlos A da Fonseca 19 , Mieke van den Heuvel 20 , Ronald Hazeleger 21 , Martijn van Eck 22 , Loek van Heerebeek 23 , Eric Boersma 1 , Michiel Rienstra 2 , Rudolf A de Boer 1 , Jasper J Brugts 1
Affiliation
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 resynchronisation 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 nonsignificant). In the unadjusted analysis of the primary endpoint quality-of-life change, weak trends towards a less pronounced effect in older patients (Pinteraction = 0.03; adjusted Pinteraction = 0.33) and diabetics (Pinteraction = 0.01; adjusted Pinteraction = 0.06) 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.
中文翻译:
慢性心力衰竭中的肺动脉压监测:MONITOR-HF 试验中临床相关亚组的影响
背景和目的 在慢性心力衰竭 (HF) 患者中,MONITOR-HF 试验证明了肺动脉 (PA) 引导的心力衰竭治疗优于标准护理,可改善生活质量、减少心力衰竭住院率和平均 PA 压力。本研究旨在评估这些益处与临床相关亚组的一致性。方法 在 MONITOR-HF 试验中,根据年龄、性别、心房颤动、糖尿病、左心室射血分数、心力衰竭病因、心脏再同步治疗和植入式心律转复除颤器,在预定义的亚组中评估 PA 引导的心力衰竭治疗的效果。结果测量基于主要试验的显着性,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。未调整的和多重测试调整的交互项都被提出。结果 PA 监测对生活质量、临床事件和 PA 压力的影响在预定义的亚组中是一致的,在所有终点类别内或之间没有任何临床相关的异质性(所有调整后的相互作用 P 值均不显着)。在对主要终点生活质量变化的未经调整的分析中,观察到老年患者(Pinteraction = 0.03;调整后的 Pinteraction = 0.33)和糖尿病患者(Pinteraction = 0.01;调整后的 Pinteraction = 0.06)中效果不太明显的微弱趋势。然而,在调整多次测试后,这些交互作用并没有持续存在。 结论 该亚组分析证实了 MONITOR-HF 试验中在临床相关亚组中观察到的 PA 引导的心力衰竭治疗的一致益处,强调了其在改善慢性心力衰竭患者的生活质量、临床和 PA 压力终点方面的功效。
更新日期:2024-05-09
中文翻译:
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慢性心力衰竭中的肺动脉压监测:MONITOR-HF 试验中临床相关亚组的影响
背景和目的 在慢性心力衰竭 (HF) 患者中,MONITOR-HF 试验证明了肺动脉 (PA) 引导的心力衰竭治疗优于标准护理,可改善生活质量、减少心力衰竭住院率和平均 PA 压力。本研究旨在评估这些益处与临床相关亚组的一致性。方法 在 MONITOR-HF 试验中,根据年龄、性别、心房颤动、糖尿病、左心室射血分数、心力衰竭病因、心脏再同步治疗和植入式心律转复除颤器,在预定义的亚组中评估 PA 引导的心力衰竭治疗的效果。结果测量基于主要试验的显着性,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。未调整的和多重测试调整的交互项都被提出。结果 PA 监测对生活质量、临床事件和 PA 压力的影响在预定义的亚组中是一致的,在所有终点类别内或之间没有任何临床相关的异质性(所有调整后的相互作用 P 值均不显着)。在对主要终点生活质量变化的未经调整的分析中,观察到老年患者(Pinteraction = 0.03;调整后的 Pinteraction = 0.33)和糖尿病患者(Pinteraction = 0.01;调整后的 Pinteraction = 0.06)中效果不太明显的微弱趋势。然而,在调整多次测试后,这些交互作用并没有持续存在。 结论 该亚组分析证实了 MONITOR-HF 试验中在临床相关亚组中观察到的 PA 引导的心力衰竭治疗的一致益处,强调了其在改善慢性心力衰竭患者的生活质量、临床和 PA 压力终点方面的功效。