Long-term effects of enhanced external counterpulsation in the management of patients with ischemic chronic heart failure

Abstract

Aim. To study the long-term effects of complex therapy with the addition of enhanced external counterpulsation (EECP) in patients with stable coronary artery disease (CAD) complicated by chronic heart failure (CHF).Material and methods. In the open randomized trial EXCEL (NCT05913778), 118 Patients with the verified ischemic CHF NYHA class II-III with reduced or intermediate left ventricular ejection fraction were included. They were randomized into group 1 (n=59) — optimal medical therapy (OMT) and EECP (35 hours, 2 courses per year), group 2 (n=59) — OMT and EECP (35 hours, 1 course per year). The primary endpoint was the proportion of patients with a 6-minute walk test (6MWT) increase of at least 20% from baseline. The secondary composite endpoint included adverse cardiovascular clinical outcomes (myocardial infarction, revascularization, stroke, death), new cases of atrial fibrillation, diabetes mellitus, decreased renal function, and hospitalizations for CHF.Results. The average CHF NYHA class decreased in group 1 from 2.41±0.49 initially to 1.95±0.47 after 24 months (p<0.001), and in group 2 from 2.37±0.49 to 2.19±0.43, respectively (p=0.021; p<0.001 for intergroup differences). The proportion of patients with an increase in distance walked during 6MWT >20% (primary endpoint) in groups 1 and 2 after 24 months was 98.3% (n=58) and 79.7% (n= 46) respectively (p<0.001). Cumulative event-free survival in group 1 was significantly higher than that in group 2 (88.1% versus 66.1%; Chi2 = 7.792, p = 0.005). In group 1, compared with group 2, the chances of combined endpoint development were 4.2 times lower (odds ratio 0.263, 95% confidence interval 0.101-0.683; p=0.006), and failure to achieve the primary endpoint (increased distance walked in 6MCT >20%) — 16.4 times lower (odds ratio 0.061, 95% confidence interval 0.008-0.484; p=0.009).Conclusion. Over the 24-month study period, the effect of EECP in patients with coronary artery disease complicated by CHF demonstrated a stable improvement in exercise tolerance, as well as a decrease in the incidence of adverse clinical outcomes, significantly more pronounced in the group with a large number of EECP procedures