Enhanced external counterpulsation in the management of patients with ischemic heart failure: long-term impact on clinical outcomes

Abstract

Aim. To study the long-term effect of complex therapy with enhanced external counterpulsation (EECP) on clinical parameters and outcomes in patients with stable coronary artery disease (CAD) complicated by heart failure (HF).Material and methods. The randomized trial EXCEL (Long-term Effects of enhanced eXternal CountErpuLsation; NCT05913778) included 118 patients with stable CAD complicated by New-York Heart Association (NYHA) class II-III HF, who were randomized into group 1 (n=59) receiving optimal therapy and EECP (35 hours, 2 courses/ year) or group 2 (n=59) receiving optimal therapy and EECP (35 hours, 1 course/year). The 6-minute walk test (6MWT), clinical status, quality of life (MLHFQ questionnaire), N-terminal pro-brain natriuretic peptide (NT-proBNP) level, left ventricular ejection fraction, and clinical outcomes were assessed annually.Results. In both groups, improvement of HF functional class, clinical status, exercise tolerance, NT-proBNP level, and quality of life were noted. Primary endpoint (increase in 6MWT distance >20%) in groups 1 and 2 was recorded in 100 and 79,7% of patients, respectively (p<0,001), while composite endpoint (myocardial infarction, revascularization, all-cause death, hospitalization for HF, new cases of atrial fibrillation, type 2 diabetes, stage 3-5 chronic kidney disease) in 18,6 and 52,5%, respectively. The odds ratio for primary and composite endpoint in group 1 was 0,207 (95% confidence interval: 0,090-0,475; p<0,001) and 0,032 (95% confidence interval 0,002-0,553; p=0,018).Conclusion. The EXCEL study demonstrated a stable favorable effect of EECP in patients with HF complicated by CAD on clinical indicators and outcomes, which were significantly more pronounced in the group with 2 courses of EECP (70 hours) per year compared to a single annual course.