Autologous Stem cell Transplantation in Acute Myocardial Infarction - ASTAMI

Nov 16, 2005
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Date Presented:
01/01/2005
Date Published:
01/01/2006
Date Updated:
11/16/2005
Original Posted Date:
11/16/2005
References

Description:

The goal of the trial was to evaluate treatment with intracoronary mononuclear autologous bone marrow cell (BMC) therapy among patients with acute anterior myocardial infarction (MI) treated with primary percutaneous coronary intervention (PCI).

Study Design

Study Design:

Patients Screened: 1,608
Patients Enrolled: 100
Mean Follow Up: 6 months
Mean Patient Age: Mean age 57 years
Female: 16

Patient Populations:

Anterior wall MI treated with primary PCI with stenting of the LAD artery

Primary Endpoints:

Ejection fraction at 6 months, assessed by SPECT, echocardiography, and MRI

Drug/Procedures Used:

Patients with MI successfully treated with primary PCI were randomized 3-5 days post-MI in an open-label manner to treatment with intracoronary infusion of the infarct-related artery with mononuclear cell therapy (BMC group; n = 50) or control (n = 50). Due to ethical considerations, the control group did not have bone marrow aspiration performed. The mononuclear cells were isolated from bone marrow aspirates 4-6 days after MI.

Single-photon emission computed tomography (SPECT) and echocardiography were performed at baseline and at 6 months. Magnetic resonance imaging (MRI) was also performed 2-3 weeks post-MI and at 6 months.

Principal Findings:

Cells were injected a median of 6 days post-MI. Baseline characteristics were well balanced between groups, with 29% having thrombolysis prior to PCI, 9% diabetics, 44% smokers, and 34% hypertensives. Median time from symptom onset to PCI was 210 minutes in the bone marrow group and 230 minutes in the control group.

Ejection fraction at baseline was 42% per SPECT and 46% per echocardiography. On 2-3 week post-MI MRI, ejection fraction was 54%. At 6-month follow-up, there was no difference between groups in the primary endpoint of change in ejection fraction by SPECT (+8.1% for BMC vs. +7.0% for control, p = 0.77), by echocardiography (+3.1% for BMC vs. +2.1% for control, p = 0.70), or by MRI (+1.2% for BMC vs. +4.3% for control, p = 0.054). There was also no difference in change in infarct size by either SPECT (-11.0% for BMC vs. -7.8% for control, p = 0.21) or MRI (-0.7% for BMC vs. -2.6% for control, p = 0.07). Change in end-diastolic volume did not differ by treatment group (SPECT: -11.2 ml for BMC vs. -1.8 ml for control, p = 0.21; MRI: -6.9 ml for BMC vs. -2.8 ml for control, p = 0.49; echocardiography: 8.9 ml for BMC vs. 10.8 ml for control, p = 0.74).

Interpretation:

Among patients with acute anterior wall MI successfully treated with primary PCI, intracoronary injection of mononuclear BMCs a mean of 6 days post-MI was not associated with differences in change in ejection fraction at 6 months compared with control.

The results of the present trial differ from those of the REPAIR–AMI trial, which showed improvements in ejection fraction assessed by ventriculography at 4 months with progenitor BMCs compared with placebo, as well as the results of the BOOST trial, which showed improvements in ejection fraction assessed by MRI at 6 months with autologous BMCs compared with control. While the present trial enrolled only patients with a left anterior descending (LAD) artery MI, the earlier trials enrolled anterior and nonanterior MI patients. However, the BOOST trial reported similar results of reduction in ejection fraction in the subgroup of patients with LAD infarcts. It is unclear why the results of the present trial differ from earlier studies.

References:

Lunde K, Solheim S, Aakhus A, et al. Intracoronary injection of mononuclear bone marrow cells in acute myocardial infarction. N Engl J Med 2006;355:1199-209.

Presented by Dr. Ketil Lunde at the American Heart Association Scientific Sessions, Dallas, Texas, November 2005.

Keywords: Myocardial Infarction, Bone Marrow Cells, Follow-Up Studies, Tomography, Emission-Computed, Single-Photon, Magnetic Resonance Imaging, Diabetes Mellitus, Cell- and Tissue-Based Therapy, Stents, Echocardiography, Percutaneous Coronary Intervention


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