title: A pilot study of chronic, low-dose epoetin-{beta} following percutaneous coronary intervention suggests safety, feasibility, and efficacy in patients with symptomatic ischaemic heart failure.
abstract: OBJECTIVE
  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.
  
  
  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 VO(2). 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 VO(2) 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 VO(2) 3.0 ± 1.6, P = ns). No significant difference regarding peak VO(2) 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.
  
  
  BACKGROUND
  NCT00568542.
authors.affiliation: Franz-Volhard Clinic, Charité Campus Buch, Berlin, Germany. martin.bergmann@charite.de
authors.forename: Martin W
authors.initials: MW
authors.lastname: Bergmann
authors.forename: Sven
authors.initials: S
authors.lastname: Haufe
authors.forename: Florian
authors.initials: F
authors.lastname: von Knobelsdorff-Brenkenhoff
authors.forename: Heidrun
authors.initials: H
authors.lastname: Mehling
authors.forename: Ralf
authors.initials: R
authors.lastname: Wassmuth
authors.forename: Ines
authors.initials: I
authors.lastname: Münch
authors.forename: Andreas
authors.initials: A
authors.lastname: Busjahn
authors.forename: Jeanette
authors.initials: J
authors.lastname: Schulz-Menger
authors.forename: Jens
authors.initials: J
authors.lastname: Jordan
authors.forename: Friedrich C
authors.initials: FC
authors.lastname: Luft
authors.forename: Rainer
authors.initials: R
authors.lastname: Dietz
mesh_terms: D000465:Algorithms; D015906:Angioplasty, Balloon, Coronary; D004311:Double-Blind Method; D004921:Erythropoietin / Q000008:administration & dosage* / Q000097:blood; D017079:Exercise Tolerance; D005260:Female; D006333:Heart Failure / Q000150:complications / Q000188:drug therapy*; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000150:complications; D010101:Oxygen Consumption; D010865:Pilot Projects; D011994:Recombinant Proteins; D013318:Stroke Volume; D016277:Ventricular Function, Left
chemical_list: D006454:Hemoglobins; D011994:Recombinant Proteins; C103998:epoetin beta; D004921:Erythropoietin