The EXCEL Study: Long-term Observation of the Effectiveness of Drug and Non-drug Rehabilitation in Patients with Ischemic Heart Failure.

IF 0.5 4区医学 Q4 CARDIAC & CARDIOVASCULAR SYSTEMS

Kardiologiya Pub Date : 2024-01-31 DOI:10.18087/cardio.2024.1.n2615

Yu N Belenkov, A S Lishuta, O A Slepova, N S Nikolaeva, N V Khabarova, G M Dadashova, E V Privalova

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引用次数: 0

Abstract

Aim: To study the long-term effect of enhanced external counterpulsation (EECP) therapy on exercise tolerance, quality of life (QoL), and indicators of the structural and functional state of the cardiovascular system in patients with stable ischemic heart disease (IHD) complicated by chronic heart failure (CHF).

Material and methods: This open randomized EXCEL study included 120 patients with verified IHD complicated by NYHA II-III functional class CHF with reduced or mid-range left ventricular (LV) ejection fraction. Patients were randomized into group 1 (n=40), optimal drug therapy (ODT) and EECP (35 hours, 2 courses per year); group 2 (n=40), ODT and EECP (35 hours, 1 course per year); and group 3 (control; n=40), ODT and placebo counterpulsation (35 h, 1 course per year). All patients underwent a 6-minute walk test (6MWT), evaluation of clinical status, QoL with the MLHFQ and SF-36 questionnaires, structural and functional state of large blood vessels and microvasculature, measurement of brain natriuretic peptide precursor (NT-proBNP), and echocardiography at baseline and after 12 months.

Results: In groups 1 and 2 after 12 months, the 6MWT distance increased statistically significantly (44.5 and 24.9%, respectively) and the following indexes improved: QoL (SF-36, MLHFQ), the condition of large blood vessels (phase shift, radial augmentation index, central aortic systolic pressure (CASP)) and microvasculature (occlusion index, percentage of perfused capillaries, percentage of capillary recovery), and the LV systolic function (from 40.6±7.5 to 47.5±10.2% and from 41.3± 6.8 to 43.9±10.3%, respectively). The proportion of patients with a >20% increase in the 6MWT at 12 months was 97.5, 72.5, and 7.7%, respectively. A statistically significant decrease in NT-proBNP was observed in all groups. In group 3, the incidence of hospitalizations for CHF and the risk of the composite endpoint were significantly higher.

Conclusion: For the 12-month study period, the effects of EECP in patients with IHD complicated by CHF included improvements in exercise tolerance, QoL, vascular and cardiac functional parameters, and a decrease in the incidence of adverse outcomes.

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EXCEL 研究：缺血性心力衰竭患者药物和非药物康复疗效的长期观察。

目的：研究增强体外反搏（EECP）疗法对稳定型缺血性心脏病（IHD）并发慢性心力衰竭（CHF）患者的运动耐量、生活质量（QoL）以及心血管系统结构和功能状态指标的长期影响：这项开放式随机 EXCEL 研究纳入了 120 例经确诊的 IHD 患者，这些患者均并发 NYHA II-III 功能分级 CHF，且左心室射血分数降低或处于中等水平。患者被随机分为第1组（40人），最佳药物治疗（ODT）和EECP（35小时，每年2个疗程）；第2组（40人），ODT和EECP（35小时，每年1个疗程）；第3组（对照组；40人），ODT和安慰剂反搏（35小时，每年1个疗程）。所有患者均接受了 6 分钟步行测试（6MWT）、临床状态评估、MLHFQ 和 SF-36 问卷调查的 QoL、大血管和微血管的结构和功能状态、脑钠肽前体（NT-proBNP）测量以及基线和 12 个月后的超声心动图检查：结果：12 个月后，第 1 组和第 2 组的 6MWT 距离在统计学上显著增加（分别为 44.5% 和 24.9%），以下指标也有所改善：QoL（SF-36、MLHFQ）、大血管状况（相位移动、径向增强指数、主动脉中心收缩压（CASP））和微血管状况（闭塞指数、灌注毛细血管百分比、毛细血管恢复百分比）以及左心室收缩功能（分别从 40.6±7.5% 到 47.5±10.2% 和从 41.3±6.8% 到 43.9±10.3%）均有所改善。12个月时，6MWT增加20%的患者比例分别为97.5%、72.5%和7.7%。所有组别中，NT-proBNP 均有统计学意义上的明显下降。在第 3 组中，因慢性阻塞性肺病住院的发生率和综合终点的风险明显更高：在为期 12 个月的研究中，EECP 对并发心房颤动的 IHD 患者的效果包括改善运动耐量、生活质量、血管和心脏功能参数，以及降低不良后果的发生率。

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来源期刊

Kardiologiya 医学-心血管系统

CiteScore

1.70

自引率

20.00%

发文量

审稿时长

3-8 weeks

期刊介绍： “Kardiologiya” (Cardiology) is a monthly scientific, peer-reviewed journal committed to both basic cardiovascular medicine and practical aspects of cardiology. As the leader in its field, “Kardiologiya” provides original coverage of recent progress in cardiovascular medicine. We publish state-of-the-art articles integrating clinical and research activities in the fields of basic cardiovascular science and clinical cardiology, with a focus on emerging issues in cardiovascular disease. Our target audience spans a diversity of health care professionals and medical researchers working in cardiovascular medicine and related fields. The principal language of the Journal is Russian, an additional language – English (title, authors’ information, abstract, keywords). “Kardiologiya” is a peer-reviewed scientific journal. All articles are reviewed by scientists, who gained high international prestige in cardiovascular science and clinical cardiology. The Journal is currently cited and indexed in major Abstracting & Indexing databases: Web of Science, Medline and Scopus. The Journal''s primary objectives Contribute to raising the professional level of medical researchers, physicians and academic teachers. Present the results of current research and clinical observations, explore the effectiveness of drug and non-drug treatments of heart disease, inform about new diagnostic techniques; discuss current trends and new advancements in clinical cardiology, contribute to continuing medical education, inform readers about results of Russian and international scientific forums; Further improve the general quality of reviewing and editing of manuscripts submitted for publication; Provide the widest possible dissemination of the published articles, among the global scientific community; Extend distribution and indexing of scientific publications in major Abstracting & Indexing databases.