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G-CSF treatment for STEMI: final 3-year follow-up of the randomised placebo-controlled STEM-AMI trial
  1. Felice Achilli1,
  2. Cristina Malafronte2,
  3. Stefano Maggiolini3,
  4. Laura Lenatti2,
  5. Lidia Squadroni4,
  6. Giuseppe Gibelli5,
  7. Maurizio C Capogrossi6,
  8. Viola Dadone7,
  9. Francesco Gentile7,
  10. Beatrice Bassetti8,
  11. Filiberto Di Gennaro9,
  12. Paola Camisasca1,
  13. Ivan Calchera1,
  14. Laura Valagussa1,
  15. Gualtiero I Colombo10,
  16. Giulio Pompilio8,11,12,
  17. for the STEM-AMI trial Investigators
  1. 1Department of Cardiology, San Gerardo Hospital, Monza, Italy
  2. 2Department of Cardiology, A. Manzoni Hospital, Lecco, Italy
  3. 3Department of Cardiology, San L. Mandic Hospital, Merate, Lecco, Italy
  4. 4Department of Cardiology, San Carlo Hospital, Milan, Italy
  5. 5Cardiology Unit, Clinica San Carlo, Paderno Dugnano, Italy
  6. 6Laboratory of Vascular Pathology, Istituto Dermopatico dell'Immacolata IRCCS, Rome, Italy
  7. 7Department of Cardiology, Bassini Hospital, Cinisello Balsamo, Milan, Italy
  8. 8Department of Clinical and Community Sciences, University of Milan, Milan, Italy
  9. 9Department of Radiology, San Gerardo Hospital, Monza, Italy
  10. 10Laboratory of Immunology and Functional Genomics, Centro Cardiologico Monzino IRCCS, Milan, Italy
  11. 11Laboratory of Vascular Biology and Regenerative Medicine, Centro Cardiologico Monzino IRCCS, Milan, Italy
  12. 12Department of Cardiovascular Surgery, Centro Cardiologico Monzino IRCCS, Milan, Italy
  1. Correspondence to Dr Felice Achilli, Department of Cardiology, San Gerardo Hospital, Via Pergolesi 33, Monza 20900, Italy; f.achilli{at}alice.it

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.

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