Background: The efficacy of intracoronary infusion of the mobilized peripheral blood stem cell with G-CSF has not been compared between patients with AMI versus OMI. And the possible association between neointimal hyperplasia and G-CSF-based stem cell therapy also has not been tested in the situation of drug eluting stent (DES).
Methods: We randomly allocated 112 patients with MI who had undergone coronary revascularization with DES implantation for the culprit lesion into four groups. Until now 55 patients completed 6m F/U; AMI-cell infusion (n=19), AMI-control (n=10), OMI-cell infusion (n=13), and OMI-control group (n=13). In cell infusion groups, PBSCs were mobilized by G-CSF for 3 days and selectively delivered to infarcted myocardium by trans-radial approach and over-the-wire balloon catheter.
Results:
At 6month F/U of MRI, cell infusion in AMI significantly increased LVEF (from 49.8% [SD 10.1] to 56.6% [9.7], p < 0.01) and decreased LVESV (-6.1mL [18.7], p < 0.01), compared with the control AMI patients (from 52.3% [12.7] to 54.7% [14.6], +2.6mL [24.4]). Furthermore, cell infusion significantly improved perfusion score measured by SPECT and coronary flow reserve (CFR) compared with the control AMI (from 1.6 [0.6] to 2.6 [0.7] vs 1.7 [0.4] to 2.3 [0.6], p < 0.01).
In OMI, however, cell infusion did not change LVEF (from 48.0% [SD 13.0] to 48.7% [11.9], p = 0.82) or LVESV (-0.7mL [15.3], p =0.57) compared to control OMI patients (from 44.9% [11.5] to 44.6% [12.8], +0.9mL [17.2]). It also did not improve the perfusion or CFR of infarcted myocardium in OMI (from 2.1 [0.7] to 2.8 [0.9] vs 2.0 [0.8] to 2.1 [0.8], p =0.41).
G-CSF-based cell therapy did not aggravate the neointimal growth at DES (0.23 vs 0.25, p = 0.22).
Conclusion: Interim analysis of MAGIC cell-DES trial showed that intracoronary infusion of the mobilized PBSC with G-CSF improved contractility and perfusion of infarcted myocardium more in patients with AMI than in those with OMI, which should be confirmed in the final analysis of this trial. DES is a good modality for revascularization of patients who undergo cytokine-based stem cell therapy.