REVIVAL-2 - REVIVAL-2

Description:

The goal of the trial was to evaluate treatment with stem cell mobilization by granulocyte-colony stimulating factors (G-CSFs) compared with placebo among patients with acute myocardial infarction (MI) who had successful reperfusion with primary percutaneous coronary intervention (PCI).

Study Design

Study Design:

Patients Enrolled: 114
Mean Follow Up: Six months
Mean Patient Age: Mean age 60 years
Female: 21

Patient Populations:

Acute MI with successful reperfusion by PCI within 12 hours of symptom onset; and infarct size of ≥5% of left ventricle on SPECT within five days of PCI

Primary Endpoints:

Reduction of infarct size measured as the difference in left ventricular infarct size from baseline to six-month follow-up

Secondary Endpoints:

Improvement in left ventricular ejection fraction from baseline to six months; and angiographic restenosis, defined as stenosis ≥50%

Drug/Procedures Used:

Patients with acute MI who had successful reperfusion with primary PCI were randomized within five days of PCI to either treatment with G-CSF (subcutaneous 10 µg/kg for five days) (n=56) or placebo (n=58). Patients underwent SPECT scans and magnetic resonance imaging at baseline and six months.

Principal Findings:

Anterior MI was present in 51% of patients, and 14% were diabetic. Infarct size at baseline was identical in both groups (19.1% each) with no difference in follow-up infarct size (12.9% for G-CSF vs. 14.2% for placebo, p=0.78), resulting in no difference in the primary endpoint in reduction in infarct size (6.2% for G-CSF vs. 4.9% for placebo, p=0.56). Left ventricular ejection fraction also did not differ between the G-CSF and placebo groups at baseline (51.3% vs. 49.2%, p=0.33) or follow-up (51.8% vs. 51.2%, p=0.85).

Angiographic restenosis was similar in both groups (35% for G-CSF group vs. 31% for placebo, p=0.79). There was no difference in the clinical endpoints of death or MI (1.8% vs. 1.7%, p=NS) or target lesion revascularization (28.6% vs. 31.0%, p=0.93). Side effects were more frequent in the G-CSF group compared with placebo (27% vs. 10%), with moderate bone pain the most common side effect in the G-CSF group (n=7).

Interpretation:

Among patients with acute MI who had successful reperfusion with primary PCI, treatment with stem cell mobilization by G-CSFs was not associated with a difference in reduction in infarct size at six months compared with placebo.

Prior studies totaling only 60 patients had suggested favorable effects on left ventricular remodeling with G-CSF, but had seen an increase in restenosis. While there was no increased risk of restenosis with G-CSF, there was also no efficacy benefit. However, these data should be interpreted only in the setting of G-CSF stimulation of stem cell mobilization. It is possible that other mechanisms of stem cell mobilization may show different results.

References:

Zohlnhofer D, et al. Stem Cell Mobilization by Granulocyte Colony-Stimulating Factor in Patients With Acute Myocardial Infarction: A Randomized Controlled Trial. JAMA 2006;295 1003-1010.

Presented by Dr. Dietind Zohlnhofer at TCT 2005, Washington, DC.

Clinical Topics: Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Interventions and Imaging, Computed Tomography, Magnetic Resonance Imaging, Nuclear Imaging

Keywords: Myocardial Infarction, Follow-Up Studies, Ventricular Function, Left, Tomography, Emission-Computed, Single-Photon, Coronary Disease, Pain, Magnetic Resonance Imaging, Percutaneous Coronary Intervention, Granulocyte Colony-Stimulating Factor, Ventricular Remodeling, Hematopoietic Stem Cell Mobilization, Stroke Volume, Diabetes Mellitus


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