title: G-CSF treatment for STEMI: final 3-year follow-up of the randomised placebo-controlled STEM-AMI trial.
abstract: OBJECTIVE
  To assess whether granulocyte colony-stimulating 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 µg/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.
authors.affiliation: Department of Cardiology, San Gerardo Hospital, , Monza, Italy.
authors.forename: Felice
authors.initials: F
authors.lastname: Achilli
authors.forename: Cristina
authors.initials: C
authors.lastname: Malafronte
authors.forename: Stefano
authors.initials: S
authors.lastname: Maggiolini
authors.forename: Laura
authors.initials: L
authors.lastname: Lenatti
authors.forename: Lidia
authors.initials: L
authors.lastname: Squadroni
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Gibelli
authors.forename: Maurizio C
authors.initials: MC
authors.lastname: Capogrossi
authors.forename: Viola
authors.initials: V
authors.lastname: Dadone
authors.forename: Francesco
authors.initials: F
authors.lastname: Gentile
authors.forename: Beatrice
authors.initials: B
authors.lastname: Bassetti
authors.forename: Filiberto
authors.initials: F
authors.lastname: Di Gennaro
authors.forename: Paola
authors.initials: P
authors.lastname: Camisasca
authors.forename: Ivan
authors.initials: I
authors.lastname: Calchera
authors.forename: Laura
authors.initials: L
authors.lastname: Valagussa
authors.forename: Gualtiero I
authors.initials: GI
authors.lastname: Colombo
authors.forename: Giulio
authors.initials: G
authors.lastname: Pompilio
mesh_terms: D005260:Female; D005500:Follow-Up Studies; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000150:complications* / Q000503:physiopathology / Q000628:therapy*; D011446:Prospective Studies; D013997:Time Factors; D018487:Ventricular Dysfunction, Left / Q000209:etiology / Q000517:prevention & control*; D020257:Ventricular Remodeling
chemical_list: D016179:Granulocyte Colony-Stimulating Factor