Safety and efficacy of G-CSF in patients with ischemic heart failure: The CORNER (Cell Option for Recovery in the Non-Eligible patients for Revascularization) study

Background: Demonstration that the heart is not a post-mitotic organ has led to clinical trials trying to obtain myocardial repair even in patients with heart failure. Aim of the study: To evaluate as a less invasive method for promoting cardiac repair. Methods: Thirteen patients with ischemic heart failure in NYHA and/or CCS classes >= 3 unsuitable for revascularization received G-CSF, as a compassionate use, in addition to optimal medical therapy. Symptoms and cardiac perfusion by gated-SPECT were assessed at baseline and at 4 month follow up. Results: G-CSF was generally well tolerated. NYHA and CCS classes improved significantly from 3 (IR 2.5-3) to 2 (IR 1-2.5) (p= 0.012) and from 3 (IR 1-3) to 1 (IR 1-2) (p= 0.033). Heart failure severity symptoms according to the Minnesota Living with Heart Failure Questionnaire scores exhibited a non significant improvement from 52 +/- 27 to 39 +/- 26 (p= 0.15). At the Seattle Angina Questionnaire scores (ranging from 0 to 100, higher scores indicating better status), physical limitation improved from 39 +/- 31 to 64 +/- 29 (p= 0.03), angina stability from 42 +/- 29 to 64 +/- 28 (p= 0.05), angina frequency from 53 +/- 33 to 73 +/- 26 (p= 0.04), treatment satisfaction from67 +/- 29 to 83 +/- 21 (p= 0.07), disease perception from 37 +/- 29 to 66 +/- 26 (p= 0.007). Quality of life assessed by a Visual Analogue Scale improved from 33 +/- 24 to 64 +/- 20mm(p= 0.003). Stress and differential regional perfusion scores improved significantly from 1.78 +/- 1.38 to 1.66 +/- 1.38 (p= 0.05) and from 0.35 +/- 0.68 to 0.23 +/- 0.53 (p= 0.02) respectively. Conclusions: In patients with ischemic heart failure unsuitable for revascularization, G-CSF is associated to a significant improvement of symptoms, possibly reducing stress-induced ischemia. (C) 2010 Elsevier Ireland Ltd. All rights reserved.