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Published on: June 27, 2011
G-CSF for Extensive STEMI
Felice Achilli1, Gianluca Pontone2,3, Beatrice Bassetti4
1From the Departments of Cardiology (F.A., S.R., C.M., F.S.), ASST-Monza, San Gerardo Hospital, Monza, Italy.
Insights
Early G-CSF administration improved heart function and reduced remodeling in STEMI patients. This treatment reduced infarct size and improved myocardial strain, offering a potential benefit for heart attack recovery.
Area of Science:
- Cardiology
- Regenerative Medicine
- Biomedical Engineering
Background:
- Acute myocardial infarction (AMI) can lead to adverse left ventricular (LV) remodeling and dysfunction.
- Early intervention strategies are crucial to mitigate long-term cardiac damage.
- Granulocyte colony-stimulating factor (G-CSF) has shown potential in previous studies to improve outcomes post-MI.
Purpose of the Study:
- To evaluate the effect of early G-CSF administration on LV remodeling and function in ST-segment-elevation myocardial infarction (STEMI) patients.
- To assess changes in infarct size and myocardial strain using cardiac magnetic resonance (CMR).
- To determine if G-CSF provides benefits beyond standard of care (SOC).
Main Methods:
- A Phase III randomized controlled trial (STEM-AMI OUTCOME) involving 161 STEMI patients with LV ejection fraction ≤45%.
- Patients received either SOC + G-CSF or SOC alone.
- Cardiac MRI (CMR) was performed at baseline and 6-month follow-up to assess LV volumes, ejection fraction, infarct size (late gadolinium enhancement), and myocardial strain.
Main Results:
- G-CSF treatment resulted in a significantly greater improvement in LV ejection fraction (+5.1%) and a reduction in indexed LV end-systolic volume (-6.7 mL/m²).
- Indexed late gadolinium enhancement significantly decreased in the G-CSF group, indicating reduced scar size.
- Improvements in global longitudinal strain (+2.4%) and global circumferential strain were observed in the G-CSF group.
Conclusions:
- Early G-CSF administration offers significant benefits for STEMI patients with LV dysfunction.
- G-CSF improves global systolic function, reduces adverse LV remodeling, and decreases infarct size.
- The findings support G-CSF as a valuable adjunct to standard care for STEMI patients.
Rationale:
In the exploratory Phase II STEM-AMI (Stem Cells Mobilization in Acute Myocardial Infarction) trial, we reported that early administration of G-CSF (granulocyte colony-stimulating factor), in patients with anterior ST-segment-elevation myocardial infarction and left ventricular (LV) dysfunction after successful percutaneous coronary intervention, had the potential to significantly attenuate LV adverse remodeling in the long-term.
Objective:
The STEM-AMI OUTCOME CMR (Stem Cells Mobilization in Acute Myocardial Infarction Outcome Cardiac Magnetic Resonance) Substudy was adequately powered to evaluate, in a population showing LV ejection fraction ≤45% after percutaneous coronary intervention for extensive ST-segment-elevation myocardial infarction, the effects of early administration of G-CSF in terms of LV remodeling and function, infarct size assessed by late gadolinium enhancement, and myocardial strain.
Methods And Results:
Within the Italian, multicenter, prospective, randomized, Phase III STEM-AMI OUTCOME trial, 161 ST-segment-elevation myocardial infarction patients were enrolled in the CMR Substudy and assigned to standard of care (SOC) plus G-CSF or SOC alone. In 119 patients (61 G-CSF and 58 SOC, respectively), CMR was available at baseline and 6-month follow-up. Paired imaging data were independently analyzed by 2 blinded experts in a core CMR lab. The 2 groups were similar for clinical characteristics, cardiovascular risk factors, and pharmacological treatment, except for a trend towards a larger infarct size and longer symptom-to-balloon time in G-CSF patients. ANCOVA showed that the improvement of LV ejection fraction from baseline to 6 months was 5.1% higher in G-CSF patients versus SOC (P=0.01); concurrently, there was a significant between-group difference of 6.7 mL/m2 in the change of indexed LV end-systolic volume in favor of G-CSF group (P=0.02). Indexed late gadolinium enhancement significantly decreased in G-CSF group only (P=0.04). Moreover, over time improvement of global longitudinal strain was 2.4% higher in G-CSF patients versus SOC (P=0.04). Global circumferential strain significantly improved in G-CSF group only (P=0.006).
Conclusions:
Early administration of G-CSF exerted a beneficial effect on top of SOC in patients with LV dysfunction after extensive ST-segment-elevation myocardial infarction in terms of global systolic function, adverse remodeling, scar size, and myocardial strain.
Clinical Trial Registration:
URL: https://www.clinicaltrials.gov. Unique identifier: NCT01969890.
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