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 4month 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 from 67+/-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.