A pilot study of chronic, low-dose epoetin-β following percutaneous coronary intervention suggests safety, feasibility, and efficacy in patients with symptomatic ischaemic heart failure

Aims Low‐dose epoetin‐β improved neo‐angiogenesis and cardiac regeneration in experimental models of ischaemic cardiomyopathy without raising haemoglobin. No clinical study has tested this approach to date. Methods and results We performed a randomized, placebo‐controlled, double‐blind, single‐centre study of 35 IU/kg body weight epoetin‐β given subcutaneously once weekly for 6 months started within 3 weeks after successful percutaneous coronary intervention (PCI). Patients were included if they presented with a lesion within the proximal segment of the left anterior descending artery, the right coronary artery, or circumflex and had symptomatic heart failure. Patients with ST‐segment elevation due to an acute myocardial infarct were excluded. The outcome variables were measured at baseline and at 6 months. Primary outcome measure was individual change in ejection fraction; secondary outcome was safety, change in N‐terminal pro‐brain natriuretic peptide, and peak VO2. Twenty‐four patients completed the 6‐month treatment course. No adverse event related to the treatment occurred. Low‐dose epoetin‐β following PCI significantly improved global ejection fraction as measured by echocardiography (EPO: ΔEF 5.2 ± 2.0%, P= 0.013; placebo: ΔEF 0.3 ± 1.6%, P= 0.851; P= 0.019 for the inter‐group difference) and cardiac magnetic resonance (EPO: ΔEF 3.1 ± 1.6%, P= 0.124; placebo: −1.9 ± 1.2%, P= 0.167; P= 0.042 for the inter‐group difference). N‐terminal pro‐brain natriuretic peptide levels decreased in both groups without significant inter‐group differences. Peak VO2 levels increased significantly by 3.9 ± 1.1% (P< 0.05) in the EPO group, whereas in the placebo group the increase did not reach statistical significance (Δpeak VO2 3.0 ± 1.6, P = ns). No significant difference regarding peak VO2 was observed between the EPO and placebo groups. Conclusions Low‐dose epoetin‐β treatment following PCI is safe and feasible, and has possible beneficial effects on global ejection fraction and measures of exercise capacity. Extended low‐dose epoetin‐β treatment warrants further mechanistic studies as well as larger clinical trials. Clinical Trial Registration Information: NCT00568542