Abstract 16132: Granulocyte Colony-stimulating Factor Attenuates Left Ventricular Remodelling After Acute Anterior Myocardial Infarction.
Aim: The present randomized, single-blind, placebo-controlled trial aimed at assessing the effect of granulocyte colony-stimulating factor (G-CSF) on left ventricular (LV) function and volumes in patients with anterior ST-elevation myocardial infarction and depressed left ventricular ejection fraction (EF).
Methods and Results: Sixty consecutive patients with anterior STEMI, undergoing primary angioplasty (PCI), with symptom-to-reperfusion time of 2–12 hours and EF ≤ 45% after PCI, were randomized to 5 μg/Kg G-CSF bis in die subcutaneously or placebo for 5 days, starting < 12 hours after PCI. The pre-specified primary endpoint was an increase from baseline to 6 months of 5% in LV EF, as measured by magnetic resonance imaging (MRI). Co-primary end-point was a difference ≥ 20 ml of end-diastolic volume at MRI. Infarct size and perfusion were evaluated with late gadolinium enhancement (LGE) and gated 99mTechnetium Sestamibi Single-Photon Emission Computed Tomography (SPECT). Independent core laboratories blindly analyzed all examinations. LV end-diastolic volume (EDV) and LV end-systolic volume (ESV) increased at 6-months from baseline in placebo group (n=25) (from 81.7 ± 24.4 to 94.4 ± 26.0 ml/m2, p<0.00005, and from 45.2 ± 20.0 to 53.2 ± 23.8 ml/m2, p=0.016, respectively) whereas they did not change in G-CSF group (n=24) (from 82.2 ± 20.3 to 85.7 ± 23.7 ml/m2, p=0.40; and from 46.0 ± 18.2 to 48.4 ± 20.8 ml/m2, p=0.338, respectively). No significant differences were found in EF and perfusion between groups. A significant reduction of transmural LGE segments was seen at 6 months in the G-CSF vs placebo group (from 4.38 ± 2.9 to 3.3 ± 2.6, p=0.04, and from 4.2 ± 2.6 to 3.6 ± 2.7, p=0.301, respectively). Significantly more patients of the placebo group exhibited a change of LVEDV above the median (9.3 ml/m2) when reperfusion time exceeded 180 minutes (median of time-to-reperfusion) (p=0.0123). The occurrence of severe adverse events was similar between groups.
Conclusion: Early G-CSF administration attenuates ventricular remodelling in patients with anterior STEMI and EF ≤ 45% after successful PCI.
- © 2010 by American Heart Association, Inc.