Intracoronary Autologous Bone-Marrow Cell Transfer After Myocardial Infarction: A Double-Blind, Randomized, and Placebo-Controlled Clinical Trial - Intracoronary Autologous Bone-Marrow Cell Transfer After Myocardial Infarction
The goal of the study was to evaluate the effect of treatment with intracoronary autologous bone-marrow cell transfer compared with placebo after myocardial infarction (MI) on functional recovery.
Patients Enrolled: 66
Mean Follow Up: Four months
Mean Patient Age: Mean age 56 years
Acute MI, defined as cumulative ST-segment elevation ≥6 mm; time after symptom onset >2 hours; successful reperfusion post-PCI; and documented LV dysfunction
Within 24 hours of acute MI with successful percutaneous coronary intervention (PCI), patients were randomized in a double-blind manner to intracoronary autologous bone-marrow cell transfer (n=32) or placebo (n=34). Bone marrow aspiration was performed and transferred to an open infarct-related artery. The transfer was performed intracoronary using over-the-wire balloon catheter during three coronary occlusions, each lasting 2-3 minutes.
Patients were monitored in-hospital for seven days and underwent follow-up through four months. Positron emission tomography (PET) and magnetic resonance imaging (MRI) were performed at the initial hospitalization and at four-month follow-up.
Bone marrow cell harvest volume averaged 130 ml, with 304 million total nucleated cells and 172 mononuclear cells. The infarct artery was in the left coronary in 62% of patients and in the right coronary in 37%. Post-PCI TIMI flow grade 3 was present in 91% of patients. All but one patient received aspirin, and glycoprotein IIb/IIIa inhibitors were used in 78% of the bone marrow group and 64% of the placebo group.
Global left ventricular (LV) ejection fraction increased by 2.1% in the bone marrow group, and 3.9% in the placebo group. LV mass index at four months was lower in the bone marrow group compared with the placebo group (p=0.018), as was infarct size (p=0.036). Similar results were observed in infarct size in the subgroup of patients who underwent PCI within six hours and in patients with infarct size >20% of LV mass index.
There was no difference in change in systolic wall motion from baseline to four months in the infarct region (1.1 mm for placebo vs. 0.6 mm for bone marrow, p=0.49) or in the border zone (1.1 mm vs. 0.6 mm, p=0.94). However, end diastolic wall thickness reduction was larger in the bone marrow group compared with placebo in both the infarct region (-1.7 mm vs. -1.2 mm, p=0.04) and the remote area (-0.9 mm vs. -0.4 mm, p=0.05). There were no differences in PET perfusion indices or metabolic indices in the infarct region or in the border zone.
There were no differences in adverse events during admission or at four-month follow-up, with atrial tachycardia on Holter in 19% of the bone marrow group and 15% of the placebo group.
Among patients with recent reperfusion therapy following MI, treatment with intracoronary autologous bone-marrow cell transfer was associated with reductions in infarct size compared with placebo, but was not associated with changes in LV systolic functional recovery. Additionally, bone marrow transfer was not associated with an increase in myocardial blood flow or oxidative metabolism on PET scan.
While earlier studies have evaluated autologous bone-marrow cell transfer post-MI, the present study is the first to do so in a double-blind placebo-controlled manner. Given the safety profile and the potential benefit in infarct size, larger randomized trials of autologous bone-marrow cell transfer are warranted.
Presented by Dr. Stefan Janssens at the March 2005 ACC Annual Scientific Session, Orlando, FL.
Janssens S, Dubois C, Bogaert J, et al. Autologous bone marrow-derived stem-cell transfer in patients with ST-segment elevation myocardial infarction: double-blind, randomised controlled trial. Lancet. 2006 Jan 14;367(9505):113-21.
Clinical Topics: Arrhythmias and Clinical EP, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Interventions and Imaging, Computed Tomography, Magnetic Resonance Imaging, Nuclear Imaging
Keywords: Myocardial Infarction, Bone Marrow Cells, Follow-Up Studies, Coronary Occlusion, Angioplasty, Balloon, Coronary, Magnetic Resonance Imaging, Tachycardia, Positron-Emission Tomography
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