Lack of benefi cial eff ects of granulocyte colony-stimulating factor in patients with subacute myocardial infarction undergoing late revascularization: a double-blind, randomized, placebo-controlled clinical trial

Abstract

Background Early clinical studies have suggested that administration of granulocyte-colony stimulating factor (G-CSF) may improve the clinical condition of patients suff ering from myocardial infarction (MI). This prospective, randomized, double-blind, placebo-controlled single-centre trial aims to assess the safety and clinical effi cacy of G-CSF administration in patients with subacute MI and impaired LV function undergoing delayed primary percutaneous coronary intervention (PCI).Methods A total of 16 patients (13 men, mean age 51 years) with subacute ST-segment elevation MI and a left ventricular (LV) ejection fraction (EF) of less than 45% at baseline who underwent late revascularization, were included in the study. Patients were randomized in a double-blind fashion to receive either G-CSF (at a dose of 10 μg/kg body weight) or placebo for fi ve consecutive days. End points consisted of assessment of safety parameters as well as changes of global and regional myocardial function from baseline until six months following PCI.Results G-CSF administration resulted in a signifi cant mobilization of diff erent cell populations (four-fold increase in WBC count and a six-fold increase in CD34+ cells). G-CSF treatment was well tolerated in most patients and no major adverse cardiac events or severe G-CSF-related side eff ects were identifi ed during hospitalization and at follow-up. No signifi cant diff erences were observed between the G-CSF and placebo groups regarding global and regional myocardial function parameters.Conclusion G-CSF administration is safe, but not eff ective, in improving impaired LV functional parameters in patients with subacute MI who had an impaired baseline EF of less than 45%.