Granulocyte-colony stimulating factor for large anterior ST-elevation myocardial infarction: Rationale and design of the prospective randomized phase III STEM-AMI OUTCOME trial - 18/09/15
, Cristina Malafronte, MD a, Francesca Cesana, MD, PhD a, Stefano Maggiolini, MD b, Ciro Mauro, MD c, Gaetano M. De Ferrari, MD d, Laura Lenatti, MD e, Maurizio Tespili, MD f, Paola Pasqualini, MD g, Francesco Gentile, MD h, Maurizio C. Capogrossi, MD i, Aldo Maggioni, MD j, Attilio Maseri, MD k, Gianluca Pontone, MD l, Gualtiero I. Colombo, MD, PhD m, 1, Giulio Pompilio, MD, PhD n, 1for the
STEM-AMI OUTCOME Trial Investigators
Résumé |
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 ≤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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Vol 170 - N° 4
P. 652 - octobre 2015 Retour au numéro
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