Aims The aim of this study was to assess the effect of granulocyte colony‐stimulating factor (G‐CSF) on left ventricular (LV) function and volumes in patients with anterior ST‐elevation myocardial infarction (STEMI) and depressed LV ejection fraction (EF). Methods and results Sixty consecutive patients with anterior STEMI, undergoing primary angioplasty percutaneous coronary intervention (PCI), with symptom‐to‐reperfusion time of 2–12 h and EF ≤45% after PCI, were randomized to G‐CSF 5 μg/kg b.i.d. subcutaneously (n = 24) or placebo (n = 25) for 5 days, starting <12 h after PCI. The primary endpoint was an increase from baseline to 6 months of 5% in left ventricular ejection fraction (LVEF), as measured by magnetic resonance imaging (MRI). Co‐primary endpoint was a ≥20 mL difference in end‐diastolic volume (EDV). Infarct size and perfusion were evaluated with late gadolinium enhancement (LGE) and gated 99mTechnetium Sestamibi single‐photon emission computed tomography (SPECT). Left ventricular EDV and end‐systolic volume (ESV) increased from baseline to 6 months in the placebo group (81.7 ± 24.4 to 94.4 ± 26.0 mL/m2, P < 0.00005 and 45.2 ± 20.0 to 53.2 ± 23.8 mL/m2, P = 0.016) but were unchanged in the G‐CSF group (82.2 ± 20.3 to 85.7 ± 23.7 mL/m2, P = 0.40 and 46.0 ± 18.2 to 48.4 ± 20.8 mL/m2, P = 0.338). There were no significant differences in EF or perfusion between groups. A significant reduction in transmural LGE segments was seen at 6 months in the G‐CSF vs. placebo groups (4.38 ± 2.9 to 3.3 ± 2.6, P = 0.04 and 4.2 ± 2.6 to 3.6 ± 2.7, P = 0.301, respectively). Significantly more placebo patients had a change in left ventricular end‐diastolic volume abovethe median (9.3 mL/m2) when reperfusion time exceeded 180 min (median time‐to‐reperfusion) (P = 0.0123). Severe adverse events were similar between groups. Conclusion Early G‐CSF administration attenuates ventricular remodelling in patients with anterior STEMI and EF ≤45% after successful PCI.

Granulocyte colony-stimulating factor attenuates left ventricular remodelling after acute anterior STEMI : results of the single-blind, randomized, placebo-controlled multicentre STem cEll Mobilization in Acute Myocardial Infarction (STEM-AMI) Trial / F. Achilli, C. Malafronte, L. Lenatti, F. Gentile, V. Dadone, G. Gibelli, S. Maggiolini, L. Squadroni, C. Di Leo, I. Burba, M. Pesce, L. Mircoli, M. Capogrossi, A. Di Lelio, P. Camisasca, A. Morabito, G. Colombo, G. Pompilio. - In: EUROPEAN JOURNAL OF HEART FAILURE. - ISSN 1388-9842. - 12:10(2010 Oct), pp. 1111-1121. [10.1093/eurjhf/hfq150]

Granulocyte colony-stimulating factor attenuates left ventricular remodelling after acute anterior STEMI : results of the single-blind, randomized, placebo-controlled multicentre STem cEll Mobilization in Acute Myocardial Infarction (STEM-AMI) Trial

Lenatti L;Dadone V;Morabito A;Pompilio G
2010-10

Abstract

Aims The aim of this study was to assess the effect of granulocyte colony‐stimulating factor (G‐CSF) on left ventricular (LV) function and volumes in patients with anterior ST‐elevation myocardial infarction (STEMI) and depressed LV ejection fraction (EF). Methods and results Sixty consecutive patients with anterior STEMI, undergoing primary angioplasty percutaneous coronary intervention (PCI), with symptom‐to‐reperfusion time of 2–12 h and EF ≤45% after PCI, were randomized to G‐CSF 5 μg/kg b.i.d. subcutaneously (n = 24) or placebo (n = 25) for 5 days, starting <12 h after PCI. The primary endpoint was an increase from baseline to 6 months of 5% in left ventricular ejection fraction (LVEF), as measured by magnetic resonance imaging (MRI). Co‐primary endpoint was a ≥20 mL difference in end‐diastolic volume (EDV). Infarct size and perfusion were evaluated with late gadolinium enhancement (LGE) and gated 99mTechnetium Sestamibi single‐photon emission computed tomography (SPECT). Left ventricular EDV and end‐systolic volume (ESV) increased from baseline to 6 months in the placebo group (81.7 ± 24.4 to 94.4 ± 26.0 mL/m2, P < 0.00005 and 45.2 ± 20.0 to 53.2 ± 23.8 mL/m2, P = 0.016) but were unchanged in the G‐CSF group (82.2 ± 20.3 to 85.7 ± 23.7 mL/m2, P = 0.40 and 46.0 ± 18.2 to 48.4 ± 20.8 mL/m2, P = 0.338). There were no significant differences in EF or perfusion between groups. A significant reduction in transmural LGE segments was seen at 6 months in the G‐CSF vs. placebo groups (4.38 ± 2.9 to 3.3 ± 2.6, P = 0.04 and 4.2 ± 2.6 to 3.6 ± 2.7, P = 0.301, respectively). Significantly more placebo patients had a change in left ventricular end‐diastolic volume abovethe median (9.3 mL/m2) when reperfusion time exceeded 180 min (median time‐to‐reperfusion) (P = 0.0123). Severe adverse events were similar between groups. Conclusion Early G‐CSF administration attenuates ventricular remodelling in patients with anterior STEMI and EF ≤45% after successful PCI.
Ventricular Remodeling; Magnetic Resonance Imaging; Ventricular Function, Left; Analysis of Variance; Tomography, Emission-Computed, Single-Photon; Humans; Angioplasty, Balloon, Coronary; Granulocyte Colony-Stimulating Factor; Single-Blind Method; Myocardial Reperfusion; Middle Aged; Stem Cells; Myocardial Infarction; Female; Heart Ventricles; Male; Stroke Volume
Settore MED/11 - Malattie dell'Apparato Cardiovascolare
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2434/552089
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