Abstract 1826: Granulocyte-colony Stimulating Factor as Adjunctive Treatment after Sub-acute ST Segment Elevation Myocardial Infarction Undergoing late Revascularization: Final Results of the GCSF-STEMI Trial
This investigator driven, prospective, randomized, double-blinded, placebo-controlled phase II study compares the effects of G-CSF on the improvement of myocardial function in patients undergoing delayed percutaneous coronary intervention (PCI) for ST segment elevation myocardial infarction (STEMI).
Methods: Forty-four patients with late revascularized sub-acute STEMI were treated either with G-CSF or placebo over 5 days after successful PCI. Primary end points were change of global and regional myocardial function from baseline (1 week after PCI) to 3 months after PCI assessed by magnetic resonance imaging (MRI). Secondary endpoints consisted of characterization of mobilized stem cell populations, assessment of safety parameters up to 12 months including 6-months angiography, as well as myocardial perfusion assessed by MRI.
Results: Global myocardial function from baseline (1 week after PCI) to 3 months improved in both groups, but G-CSF was not superior to placebo (Δejection fraction 6.2±9.0 vs. 5.3±9.8%, p=0.77). A slight but non-significant improvement of regional function occurred in both groups. G-CSF resulted in mobilization of endothelial progenitor cell populations and was well tolerated with a similar rate of target lesion revascularization from in-stent restenosis. In both groups major adverse cardiovascular events occurred in a comparable frequency. G-CSF resulted in significant improvement of myocardial perfusion 1 week and 1 month after PCI.
Conclusions: G-CSF treatment after PCI in sub-acute STEMI is feasible and relatively safe. However, patients do not benefit from G-CSF when PCI was performed late. G-CSF results in improved myocardial perfusion of the infarcted area, which may reflect enhanced neovascularization.