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Published on: January 24, 2014
G-CSF treatment for STEMI: final 3-year follow-up of the randomised placebo-controlled STEM-AMI trial
Felice Achilli1, Cristina Malafronte, Stefano Maggiolini
1Department of Cardiology, San Gerardo Hospital, , Monza, Italy.
Insights
Granulocyte colony-stimulating factor (G-CSF) treatment may reduce long-term adverse ventricular remodelling after ST-elevation myocardial infarction (STEMI). However, G-CSF did not improve clinical outcomes like mortality or major adverse cardiac events.
Area of Science:
- Cardiology
- Regenerative Medicine
- Biomedical Engineering
Background:
- ST-elevation myocardial infarction (STEMI) frequently leads to adverse left ventricular (LV) remodelling and dysfunction.
- Early reperfusion therapy is crucial but does not always prevent long-term cardiac damage.
- Investigating novel therapeutic strategies to mitigate post-STEMI LV remodelling is essential.
Purpose of the Study:
- To evaluate the sustained effect of granulocyte colony-stimulating factor (G-CSF) on adverse ventricular remodelling in STEMI patients with LV dysfunction.
- To determine if G-CSF treatment offers long-term benefits in preventing adverse cardiac remodelling post-STEMI.
- To assess the impact of G-CSF on clinical outcomes and cardiac structure/function over a 3-year follow-up period.
Main Methods:
- Prospective, placebo-controlled, multicentre STEM-AMI Trial involving 60 patients with anterior STEMI and LV ejection fraction (LVEF) ≤45% post-reperfusion.
- Randomization to G-CSF (5 µg/Kg b.i.d.) or placebo, with clinical event monitoring and cardiac MRI at 3-year follow-up.
- Assessment of LVEF, LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), and infarct size.
Main Results:
- No significant differences in mortality or Major Adverse Cardiac and Cerebrovascular Events (MACCE) between G-CSF and placebo groups.
- G-CSF treatment resulted in a significantly lower LV end-diastolic volume (LVEDV) at 3-year follow-up compared to placebo (170.1±8.1 vs 197.2±8.9 mL, p=0.033).
- In G-CSF treated patients, circulating CD34 cell counts at 30 days correlated inversely with 3-year LVEDV, suggesting a mechanism for reduced remodelling.
Conclusions:
- G-CSF therapy may attenuate long-term ventricular remodelling following large anterior STEMI.
- While ventricular remodelling appears reduced, G-CSF did not demonstrate significant improvements in clinical outcomes such as mortality or MACCE.
- The correlation between CD34 cells and LVEDV suggests a potential role for stem cell mobilization in G-CSF's beneficial effects on cardiac remodelling.
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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