G-CSF treatment for STEMI: Final 3-year follow-up of the randomised placebo-controlled STEM-AMI trial

Felice Achilli, Cristina Malafronte, Stefano Maggiolini, Laura Lenatti, Lidia Squadroni, Giuseppe Gibelli, Maurizio C. Capogrossi, Viola Dadone, Francesco Gentile, Beatrice Bassetti, Filiberto Di Gennaro, Paola Camisasca, Ivan Calchera, Laura Valagussa, Gualtiero I. Colombo, Giulio Pompilio

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

Objective: To assess whether granulocyte colonystimulating factor (G-CSF) treatment induces a sustained benefit on adverse remodelling in patients with large anterior ST-elevation myocardial infarction (STEMI) and left ventricular (LV) dysfunction after successful reperfusion. Methods: The STEM-AMI Trial was a prospective, placebo-controlled, multicentre study. Sixty consecutive patients with a first anterior STEMI, who underwent primary percutaneous coronary intervention 2-12 h after symptom onset, with LV ejection fraction (LVEF) ≤45% measured by echocardiography within 12 h after successful revascularisation (TIMI flow score ≥2), were randomised 1:1 to G-CSF (5 μmg/Kg body weight b.i.d.) or placebo. Clinical events and Major Adverse Cardiac and Cerebrovascular Event (MACCE) were monitored, and LVEF, LV end-diastolic (LVEDV) and end-systolic (LVESV) volumes, and infarct size were evaluated by MRI at the final 3-year follow-up. Results: Fifty-four patients completed the study, of whom 35 with MRI. No significant differences were found in mortality and MACCE between G-CSF and placebo-treated groups. The 3-year infarct size was not different between groups, whereas LVEDV was significantly lower in G-CSF (n=20) than in placebo (n=15) patients (170.1±8.1 vs 197.2±8.9 mL, respectively; p=0.033 at analysis of covariance). A significant inverse correlation was detected in G-CSF patients between the number of circulating CD34 cells at 30 days after reperfusion and the 3-year absolute and indexed LVEDV (ρ=-0.71, 95% CI -0.90 to -0.30, and ρ=-0.62, -0.86 to -0.14, respectively), or their change over time (r=-0.59, -0.85 to -0.11, and r=-0.55, -0.83 to -0.06, respectively). Conclusions: G-CSF therapy may be beneficial in attenuating ventricular remodelling subsequent to a large anterior STEMI in the long term. No differences have been detected in clinical outcome.

Original languageEnglish
Pages (from-to)574-581
Number of pages8
JournalHeart
Volume100
Issue number7
DOIs
Publication statusPublished - 2014

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Scanning Transmission Electron Microscopy
Granulocytes
Placebos
Stroke Volume
Reperfusion
Therapeutics
Ventricular Remodeling
Left Ventricular Dysfunction
Percutaneous Coronary Intervention
Multicenter Studies
Echocardiography
ST Elevation Myocardial Infarction
Body Weight
Mortality

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Achilli, F., Malafronte, C., Maggiolini, S., Lenatti, L., Squadroni, L., Gibelli, G., ... Pompilio, G. (2014). G-CSF treatment for STEMI: Final 3-year follow-up of the randomised placebo-controlled STEM-AMI trial. Heart, 100(7), 574-581. https://doi.org/10.1136/heartjnl-2013-304955

G-CSF treatment for STEMI : Final 3-year follow-up of the randomised placebo-controlled STEM-AMI trial. / Achilli, Felice; Malafronte, Cristina; Maggiolini, Stefano; Lenatti, Laura; Squadroni, Lidia; Gibelli, Giuseppe; Capogrossi, Maurizio C.; Dadone, Viola; Gentile, Francesco; Bassetti, Beatrice; Gennaro, Filiberto Di; Camisasca, Paola; Calchera, Ivan; Valagussa, Laura; Colombo, Gualtiero I.; Pompilio, Giulio.

In: Heart, Vol. 100, No. 7, 2014, p. 574-581.

Research output: Contribution to journalArticle

Achilli, F, Malafronte, C, Maggiolini, S, Lenatti, L, Squadroni, L, Gibelli, G, Capogrossi, MC, Dadone, V, Gentile, F, Bassetti, B, Gennaro, FD, Camisasca, P, Calchera, I, Valagussa, L, Colombo, GI & Pompilio, G 2014, 'G-CSF treatment for STEMI: Final 3-year follow-up of the randomised placebo-controlled STEM-AMI trial', Heart, vol. 100, no. 7, pp. 574-581. https://doi.org/10.1136/heartjnl-2013-304955
Achilli F, Malafronte C, Maggiolini S, Lenatti L, Squadroni L, Gibelli G et al. G-CSF treatment for STEMI: Final 3-year follow-up of the randomised placebo-controlled STEM-AMI trial. Heart. 2014;100(7):574-581. https://doi.org/10.1136/heartjnl-2013-304955
Achilli, Felice ; Malafronte, Cristina ; Maggiolini, Stefano ; Lenatti, Laura ; Squadroni, Lidia ; Gibelli, Giuseppe ; Capogrossi, Maurizio C. ; Dadone, Viola ; Gentile, Francesco ; Bassetti, Beatrice ; Gennaro, Filiberto Di ; Camisasca, Paola ; Calchera, Ivan ; Valagussa, Laura ; Colombo, Gualtiero I. ; Pompilio, Giulio. / G-CSF treatment for STEMI : Final 3-year follow-up of the randomised placebo-controlled STEM-AMI trial. In: Heart. 2014 ; Vol. 100, No. 7. pp. 574-581.
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abstract = "Objective: To assess whether granulocyte colonystimulating factor (G-CSF) treatment induces a sustained benefit on adverse remodelling in patients with large anterior ST-elevation myocardial infarction (STEMI) and left ventricular (LV) dysfunction after successful reperfusion. Methods: The STEM-AMI Trial was a prospective, placebo-controlled, multicentre study. Sixty consecutive patients with a first anterior STEMI, who underwent primary percutaneous coronary intervention 2-12 h after symptom onset, with LV ejection fraction (LVEF) ≤45{\%} measured by echocardiography within 12 h after successful revascularisation (TIMI flow score ≥2), were randomised 1:1 to G-CSF (5 μmg/Kg body weight b.i.d.) or placebo. Clinical events and Major Adverse Cardiac and Cerebrovascular Event (MACCE) were monitored, and LVEF, LV end-diastolic (LVEDV) and end-systolic (LVESV) volumes, and infarct size were evaluated by MRI at the final 3-year follow-up. Results: Fifty-four patients completed the study, of whom 35 with MRI. No significant differences were found in mortality and MACCE between G-CSF and placebo-treated groups. The 3-year infarct size was not different between groups, whereas LVEDV was significantly lower in G-CSF (n=20) than in placebo (n=15) patients (170.1±8.1 vs 197.2±8.9 mL, respectively; p=0.033 at analysis of covariance). A significant inverse correlation was detected in G-CSF patients between the number of circulating CD34 cells at 30 days after reperfusion and the 3-year absolute and indexed LVEDV (ρ=-0.71, 95{\%} CI -0.90 to -0.30, and ρ=-0.62, -0.86 to -0.14, respectively), or their change over time (r=-0.59, -0.85 to -0.11, and r=-0.55, -0.83 to -0.06, respectively). Conclusions: G-CSF therapy may be beneficial in attenuating ventricular remodelling subsequent to a large anterior STEMI in the long term. No differences have been detected in clinical outcome.",
author = "Felice Achilli and Cristina Malafronte and Stefano Maggiolini and Laura Lenatti and Lidia Squadroni and Giuseppe Gibelli and Capogrossi, {Maurizio C.} and Viola Dadone and Francesco Gentile and Beatrice Bassetti and Gennaro, {Filiberto Di} and Paola Camisasca and Ivan Calchera and Laura Valagussa and Colombo, {Gualtiero I.} and Giulio Pompilio",
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T1 - G-CSF treatment for STEMI

T2 - Final 3-year follow-up of the randomised placebo-controlled STEM-AMI trial

AU - Achilli, Felice

AU - Malafronte, Cristina

AU - Maggiolini, Stefano

AU - Lenatti, Laura

AU - Squadroni, Lidia

AU - Gibelli, Giuseppe

AU - Capogrossi, Maurizio C.

AU - Dadone, Viola

AU - Gentile, Francesco

AU - Bassetti, Beatrice

AU - Gennaro, Filiberto Di

AU - Camisasca, Paola

AU - Calchera, Ivan

AU - Valagussa, Laura

AU - Colombo, Gualtiero I.

AU - Pompilio, Giulio

PY - 2014

Y1 - 2014

N2 - Objective: To assess whether granulocyte colonystimulating factor (G-CSF) treatment induces a sustained benefit on adverse remodelling in patients with large anterior ST-elevation myocardial infarction (STEMI) and left ventricular (LV) dysfunction after successful reperfusion. Methods: The STEM-AMI Trial was a prospective, placebo-controlled, multicentre study. Sixty consecutive patients with a first anterior STEMI, who underwent primary percutaneous coronary intervention 2-12 h after symptom onset, with LV ejection fraction (LVEF) ≤45% measured by echocardiography within 12 h after successful revascularisation (TIMI flow score ≥2), were randomised 1:1 to G-CSF (5 μmg/Kg body weight b.i.d.) or placebo. Clinical events and Major Adverse Cardiac and Cerebrovascular Event (MACCE) were monitored, and LVEF, LV end-diastolic (LVEDV) and end-systolic (LVESV) volumes, and infarct size were evaluated by MRI at the final 3-year follow-up. Results: Fifty-four patients completed the study, of whom 35 with MRI. No significant differences were found in mortality and MACCE between G-CSF and placebo-treated groups. The 3-year infarct size was not different between groups, whereas LVEDV was significantly lower in G-CSF (n=20) than in placebo (n=15) patients (170.1±8.1 vs 197.2±8.9 mL, respectively; p=0.033 at analysis of covariance). A significant inverse correlation was detected in G-CSF patients between the number of circulating CD34 cells at 30 days after reperfusion and the 3-year absolute and indexed LVEDV (ρ=-0.71, 95% CI -0.90 to -0.30, and ρ=-0.62, -0.86 to -0.14, respectively), or their change over time (r=-0.59, -0.85 to -0.11, and r=-0.55, -0.83 to -0.06, respectively). Conclusions: G-CSF therapy may be beneficial in attenuating ventricular remodelling subsequent to a large anterior STEMI in the long term. No differences have been detected in clinical outcome.

AB - Objective: To assess whether granulocyte colonystimulating factor (G-CSF) treatment induces a sustained benefit on adverse remodelling in patients with large anterior ST-elevation myocardial infarction (STEMI) and left ventricular (LV) dysfunction after successful reperfusion. Methods: The STEM-AMI Trial was a prospective, placebo-controlled, multicentre study. Sixty consecutive patients with a first anterior STEMI, who underwent primary percutaneous coronary intervention 2-12 h after symptom onset, with LV ejection fraction (LVEF) ≤45% measured by echocardiography within 12 h after successful revascularisation (TIMI flow score ≥2), were randomised 1:1 to G-CSF (5 μmg/Kg body weight b.i.d.) or placebo. Clinical events and Major Adverse Cardiac and Cerebrovascular Event (MACCE) were monitored, and LVEF, LV end-diastolic (LVEDV) and end-systolic (LVESV) volumes, and infarct size were evaluated by MRI at the final 3-year follow-up. Results: Fifty-four patients completed the study, of whom 35 with MRI. No significant differences were found in mortality and MACCE between G-CSF and placebo-treated groups. The 3-year infarct size was not different between groups, whereas LVEDV was significantly lower in G-CSF (n=20) than in placebo (n=15) patients (170.1±8.1 vs 197.2±8.9 mL, respectively; p=0.033 at analysis of covariance). A significant inverse correlation was detected in G-CSF patients between the number of circulating CD34 cells at 30 days after reperfusion and the 3-year absolute and indexed LVEDV (ρ=-0.71, 95% CI -0.90 to -0.30, and ρ=-0.62, -0.86 to -0.14, respectively), or their change over time (r=-0.59, -0.85 to -0.11, and r=-0.55, -0.83 to -0.06, respectively). Conclusions: G-CSF therapy may be beneficial in attenuating ventricular remodelling subsequent to a large anterior STEMI in the long term. No differences have been detected in clinical outcome.

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