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Stem Cells in Myocardial Infarction - STEMMI
Description:
This was a randomized, placebo-controlled study of adjunctive granulocyte-colony stimulating factor (G-CSF) compared with placebo in ST-segment elevation myocardial infarction (STEMI) following primary percutaneous coronary intervention (PCI).
Hypothesis:
Patients with a primary PCI-treated STEMI will derive therapeutic benefit from addition of G-CSF to conventional therapy.
Study Design
Study Design:
Patients Enrolled: 78
Mean Follow Up: 6 months
Mean Patient Age: Mean age 56 years
Female: 21
Patient Populations:
Patients aged 20-70 with STEMI treated with primary PCI <12 hours after symptom onset. For inclusion, the culprit lesion was in proximal segment of a large coronary vessel, plasma creatine kinase-MB >100 mcg/L, or development of significant Q waves.
Exclusions:
Prior MI, significant lesion in nonculprit coronary vessel, ventricular arrhythmia after PCI requiring treatment, pregnancy, unprotected left main stenosis, diagnosed or suspected cancer, New York Heart Association class III or IV heart failure, or severe claustrophobia
Primary Endpoints:
Regional systolic wall thickening assessed by cardiac MRI at 1 month after PCI
Secondary Endpoints:
Change in ejection fraction, end-systolic and -diastolic dimensions by MRI and echocardiography, death, reinfarction, new revascularization, other adverse events, in-stent restenosis, and change in inflammatory parameters (CRP, ESR)
Drug/Procedures Used:
Following successful primary PCI, patients were randomized to G-CSF (10 mcg/kg/d) or placebo for 6 days. Patients underwent cardiac magnetic resonance imaging (MRI) at baseline and 6 months.
Principal Findings:
Levels of CD34 positive cell counts and leukocyte counts increased by 10-15X in G-CSF patients. There were no significant differences in sedimentation rates or C-reactive protein (CRP) levels in placebo patients compared with G-CSF patients.
At 6 months, systolic wall thickening in the infarct area did not differ in G-CSF treated patients compared with placebo (17 ± 32% vs. 17 ± 22%). Systolic thickening in the infarct border zone and noninfarcted normal myocardium tended to be lower in G-CSF treated patients (8 ± 23% and -2 ± 30%) compared with placebo (23 ± 23% and 19 ± 38%). No significant differences were identified between the two groups in end-diastolic volume, end-systolic volume, left ventricular mass by MRI, and echocardiography.
Initial infarct size was similar in the two groups (median 8 g). Infarct size was unchanged from baseline to 6 months. Quantitative angiographic follow-up was performed in 62 patients and no differences in diameter stenosis, late lumen loss, or binary restenosis.
The risk of severe adverse events did not differ by treatment group. The target vessel revascularization rate in the follow-up period was similar in the two treatment groups.
Interpretation:
Among patients with STEMI successfully treated with primary PCI, use of G-CSF was not associated with a difference in infarct size or adverse remodeling of the left ventricle. G-CSF did not enhance the restenotic process.
References:
Kastrup J, et al. Presented at the Late-Breaking Clinical Trials Session of the i2 Summit Annual Scientific Session of the American College of Cardiology, Atlanta, GA, March 12, 2006.
Ripa RS, Jorgensen E, Wang Y, et al. Stem cell mobilization induced by subcutaneous granulocyte-colony stimulating factor to improve cardiac regeneration after acute ST-elevation myocardial infarction: result of the double-blind, randomized, placebo-controlled stem cells in myocardial infarction (STEMMI) trial. Circulation 2006;113:1983-92.
Keywords: Myocardial Infarction, C-Reactive Protein, Follow-Up Studies, Leukocyte Count, Creatine Kinase, MB Form, Constriction, Pathologic, Coronary Vessels, Heart Ventricles, Magnetic Resonance Imaging, Echocardiography, Percutaneous Coronary Intervention, Granulocyte Colony-Stimulating Factor
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