Alexey S Lishuta, Olga A Slepova, Nadezhda A Nikolaeva, Yuri N Belenkov
{"title":"长期强化体外反搏治疗缺血性心衰患者的心血管效应:随机、安慰剂对照、开放标签临床试验","authors":"Alexey S Lishuta, Olga A Slepova, Nadezhda A Nikolaeva, Yuri N Belenkov","doi":"10.3390/jcdd12090352","DOIUrl":null,"url":null,"abstract":"<p><p>(1) Background. Although treatment with enhanced external counterpulsation (EECP) in patients with ischemic chronic heart failure (CHF) is pathophysiologically justified, its long-term vascular effects remain insufficiently defined. We aimed to study the vascular effects of long-term complex treatment (36 months) including EECP in patients with ischemic CHF, and to examine the relationship between these effects and clinical outcomes. (2) Methods. A total amount of 120 patients with ischemic CHF were randomized to receive one course of EECP per year (35 h; Group 1), two courses of EECP per year (70 h; Group 2), or one course of placebo-counterpulsation per year (35 h; Group 0;). For a period of 36 months, all patients underwent annual assessments including transthoracic echocardiography, nailfold videocapillaroscopy, finger photoplethysmography, applanation tonometry, exercise tolerance testing, and clinical outcome monitoring. (3) Results. Compared to the placebo group, long-term EECP treatment in patients with ischemic CHF, was accompanied by a significantly greater increase in exercise tolerance (∆23.5-45.0% vs. 7.0%; <i>p</i> < 0.001) and improvements in left ventricular ejection fraction (∆9.9-19.6% vs. 5.6%; <i>p</i> < 0.001) and myocardial stress (decrease in NT-proBNP level ∆-80.4--82.4% vs. -75.8%; <i>p</i> < 0.001), as well as both functional and structural vascular parameters (<i>p</i> < 0.001). The effect size depended on the annual number of EECP courses. The highest event-free survival was found in Group 2. At 36 months, improvement of vascular parameters emerged as stronger predictors of reduced cardiovascular event risk compared to the 12-month. (4) Conclusions. Long-term EECP treatment of patients with ischemic CHF improves both functional and structural vascular parameters, with an increasing role of their improvement in reducing the risk of cardiovascular events after 36 months.</p>","PeriodicalId":15197,"journal":{"name":"Journal of Cardiovascular Development and Disease","volume":"12 9","pages":""},"PeriodicalIF":2.3000,"publicationDate":"2025-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12470607/pdf/","citationCount":"0","resultStr":"{\"title\":\"Cardiovascular Effects of Long-Term Treatment with Enhanced External Counterpulsation in Patients with Ischemic Heart Failure: Randomized, Placebo-Controlled, Open-Label Clinical Trial.\",\"authors\":\"Alexey S Lishuta, Olga A Slepova, Nadezhda A Nikolaeva, Yuri N Belenkov\",\"doi\":\"10.3390/jcdd12090352\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>(1) Background. Although treatment with enhanced external counterpulsation (EECP) in patients with ischemic chronic heart failure (CHF) is pathophysiologically justified, its long-term vascular effects remain insufficiently defined. We aimed to study the vascular effects of long-term complex treatment (36 months) including EECP in patients with ischemic CHF, and to examine the relationship between these effects and clinical outcomes. (2) Methods. A total amount of 120 patients with ischemic CHF were randomized to receive one course of EECP per year (35 h; Group 1), two courses of EECP per year (70 h; Group 2), or one course of placebo-counterpulsation per year (35 h; Group 0;). For a period of 36 months, all patients underwent annual assessments including transthoracic echocardiography, nailfold videocapillaroscopy, finger photoplethysmography, applanation tonometry, exercise tolerance testing, and clinical outcome monitoring. (3) Results. Compared to the placebo group, long-term EECP treatment in patients with ischemic CHF, was accompanied by a significantly greater increase in exercise tolerance (∆23.5-45.0% vs. 7.0%; <i>p</i> < 0.001) and improvements in left ventricular ejection fraction (∆9.9-19.6% vs. 5.6%; <i>p</i> < 0.001) and myocardial stress (decrease in NT-proBNP level ∆-80.4--82.4% vs. -75.8%; <i>p</i> < 0.001), as well as both functional and structural vascular parameters (<i>p</i> < 0.001). The effect size depended on the annual number of EECP courses. The highest event-free survival was found in Group 2. At 36 months, improvement of vascular parameters emerged as stronger predictors of reduced cardiovascular event risk compared to the 12-month. (4) Conclusions. Long-term EECP treatment of patients with ischemic CHF improves both functional and structural vascular parameters, with an increasing role of their improvement in reducing the risk of cardiovascular events after 36 months.</p>\",\"PeriodicalId\":15197,\"journal\":{\"name\":\"Journal of Cardiovascular Development and Disease\",\"volume\":\"12 9\",\"pages\":\"\"},\"PeriodicalIF\":2.3000,\"publicationDate\":\"2025-09-13\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12470607/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Cardiovascular Development and Disease\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.3390/jcdd12090352\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Cardiovascular Development and Disease","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.3390/jcdd12090352","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
摘要
(1)背景。尽管在缺血性慢性心力衰竭(CHF)患者中采用增强外反搏(EECP)治疗在病理生理学上是合理的,但其对血管的长期影响仍不明确。我们旨在研究包括EECP在内的长期综合治疗(36个月)对缺血性CHF患者的血管影响,并探讨这些影响与临床结果之间的关系。(2)方法。120例缺血性心力衰竭患者随机分为每年1个疗程EECP (35 h,组1)、每年2个疗程EECP (70 h,组2)或每年1个疗程安慰剂-反搏(35 h,组0)。在36个月的时间里,所有患者每年进行一次评估,包括经胸超声心动图、甲襞视频毛细血管镜检查、手指光体积脉搏图、压平张力测量、运动耐量测试和临床结果监测。(3)结果。与安慰剂组相比,长期EECP治疗缺血性CHF患者的运动耐量显著增加(∆23.5-45.0% vs. 7.0%, p < 0.001),左心室射血分数(∆9.9-19.6% vs. 5.6%, p < 0.001)和心肌应激(NT-proBNP水平下降∆-80.4—82.4% vs. -75.8%, p < 0.001),以及血管功能和结构参数(p < 0.001)。效应大小取决于每年EECP课程的数量。2组无事件生存率最高。在36个月时,与12个月相比,血管参数的改善成为心血管事件风险降低的更强预测因素。(4)结论。缺血性CHF患者长期EECP治疗可改善血管功能和结构参数,36个月后其改善对降低心血管事件风险的作用越来越大。
Cardiovascular Effects of Long-Term Treatment with Enhanced External Counterpulsation in Patients with Ischemic Heart Failure: Randomized, Placebo-Controlled, Open-Label Clinical Trial.
(1) Background. Although treatment with enhanced external counterpulsation (EECP) in patients with ischemic chronic heart failure (CHF) is pathophysiologically justified, its long-term vascular effects remain insufficiently defined. We aimed to study the vascular effects of long-term complex treatment (36 months) including EECP in patients with ischemic CHF, and to examine the relationship between these effects and clinical outcomes. (2) Methods. A total amount of 120 patients with ischemic CHF were randomized to receive one course of EECP per year (35 h; Group 1), two courses of EECP per year (70 h; Group 2), or one course of placebo-counterpulsation per year (35 h; Group 0;). For a period of 36 months, all patients underwent annual assessments including transthoracic echocardiography, nailfold videocapillaroscopy, finger photoplethysmography, applanation tonometry, exercise tolerance testing, and clinical outcome monitoring. (3) Results. Compared to the placebo group, long-term EECP treatment in patients with ischemic CHF, was accompanied by a significantly greater increase in exercise tolerance (∆23.5-45.0% vs. 7.0%; p < 0.001) and improvements in left ventricular ejection fraction (∆9.9-19.6% vs. 5.6%; p < 0.001) and myocardial stress (decrease in NT-proBNP level ∆-80.4--82.4% vs. -75.8%; p < 0.001), as well as both functional and structural vascular parameters (p < 0.001). The effect size depended on the annual number of EECP courses. The highest event-free survival was found in Group 2. At 36 months, improvement of vascular parameters emerged as stronger predictors of reduced cardiovascular event risk compared to the 12-month. (4) Conclusions. Long-term EECP treatment of patients with ischemic CHF improves both functional and structural vascular parameters, with an increasing role of their improvement in reducing the risk of cardiovascular events after 36 months.