TY - JOUR
T1 - Granulocyte-colony stimulating factor for large anterior ST-elevation myocardial infarction
T2 - Rationale and design of the prospective randomized phase III STEM-AMI OUTCOME trial
AU - Achilli, Felice
AU - Malafronte, Cristina
AU - Cesana, Francesca
AU - Maggiolini, Stefano
AU - Mauro, Ciro
AU - De Ferrari, Gaetano M.
AU - Lenatti, Laura
AU - Tespili, Maurizio
AU - Pasqualini, Paola
AU - Gentile, Francesco
AU - Capogrossi, Maurizio C.
AU - Maggioni, Aldo
AU - Maseri, Attilio
AU - Pontone, Gianluca
AU - Colombo, Gualtiero I.
AU - Pompilio, Giulio
PY - 2015/10/1
Y1 - 2015/10/1
N2 - Background Granulocyte-colony stimulating factor (G-CSF) has been clinically tested in ST-elevation myocardial infarction (STEMI) with mixed results. Our 3-year follow-up data from STEM-AMI trial documented a sustained benefit of G-CSF on adverse ventricular remodeling after large anterior STEMI, when administered early and at a high-dose in patients with left ventricular (LV) dysfunction. The Aim of the present trial is to establish whether G-CSF improves hard clinical long-term outcomes. Methods The STEM-AMI OUTCOME is a prospective, multicenter, randomized, open-label, phase III trial. It will include 1,530 patients with anterior STEMI undergoing primary percutaneous coronary intervention 2 to 24 hours after symptoms onset and with LV ejection fraction â‰&45% after successful reperfusion. Patients will be randomized 1:1 to G-CSF and/or standard treatment. The primary end point is a reduced occurrence of all-cause death, recurrence of myocardial infarction, or hospitalization due to heart failure in G-CSF-treated patients. Left ventricular remodeling will be assessed via cardiac ultrasound and a substudy with cardiac magnetic resonance will be carried out in 120 subjects. Accrual and follow-up periods will last 3 and 2 years, respectively. Conclusions The STEM-AMI OUTCOME study is designed to be a rigorous controlled phase III trial with adequate statistical power to conclusively assess efficacy of G-CSF treatment in STEMI.
AB - Background Granulocyte-colony stimulating factor (G-CSF) has been clinically tested in ST-elevation myocardial infarction (STEMI) with mixed results. Our 3-year follow-up data from STEM-AMI trial documented a sustained benefit of G-CSF on adverse ventricular remodeling after large anterior STEMI, when administered early and at a high-dose in patients with left ventricular (LV) dysfunction. The Aim of the present trial is to establish whether G-CSF improves hard clinical long-term outcomes. Methods The STEM-AMI OUTCOME is a prospective, multicenter, randomized, open-label, phase III trial. It will include 1,530 patients with anterior STEMI undergoing primary percutaneous coronary intervention 2 to 24 hours after symptoms onset and with LV ejection fraction â‰&45% after successful reperfusion. Patients will be randomized 1:1 to G-CSF and/or standard treatment. The primary end point is a reduced occurrence of all-cause death, recurrence of myocardial infarction, or hospitalization due to heart failure in G-CSF-treated patients. Left ventricular remodeling will be assessed via cardiac ultrasound and a substudy with cardiac magnetic resonance will be carried out in 120 subjects. Accrual and follow-up periods will last 3 and 2 years, respectively. Conclusions The STEM-AMI OUTCOME study is designed to be a rigorous controlled phase III trial with adequate statistical power to conclusively assess efficacy of G-CSF treatment in STEMI.
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U2 - 10.1016/j.ahj.2015.07.005
DO - 10.1016/j.ahj.2015.07.005
M3 - Article
C2 - 26386788
AN - SCOPUS:84941933221
VL - 170
SP - 652
EP - 658
JO - American Heart Journal
JF - American Heart Journal
SN - 0002-8703
IS - 4
ER -