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 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 ± 20 mm (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.