Bone Marrow Transfer to Enhance ST-Elevation Infarct Regeneration - BOOST

Description:

The goal of the trial was to evaluate the safety and efficacy of intracoronary administration of autologous bone marrow cell transfer compared with placebo in patients with ST elevation myocardial infarction (MI) treated with percutaneous coronary intervention (PCI).

Hypothesis:

Treatment with intracoronary administration of autologous bone marrow cell transfer will be associated with an improvement in left ventricular (LV) function compared with placebo in patients with ST elevation MI treated with PCI.

Study Design

Study Design:

Patients Screened: 78
Patients Enrolled: 60
Mean Follow Up: 6 months
Mean Patient Age: mean 56 years
Female: 30

Patient Populations:

Acute ST elevation MI treated with successful primary or rescue PCI with stenting of the infarct-related artery; and hypokinesia or akinesia involving ≥2/3 of the LV anterior, septal, lateral, or inferior wall

Exclusions:

Multivessel disease; pulmonary edema or shock; or renal or hepatic dysfunction

Primary Endpoints:

Change from baseline to six months in LVEF

Secondary Endpoints:

Changes in LV end-diastolic volume index, LV end-systolic volume index, LV mass index, and late contrast enhancement

Drug/Procedures Used:

Patients who had undergone successful primary or rescue PCI for ST elevation MI were randomized to the bone marrow cell transfer arm (n=30) or control (n=30). Bone marrow was aspirated in patients in the active treatment arm and later infused intracoronary into the infarct-related artery via a balloon catheter. Magnetic resonance (MR) was performed at baseline (mean 3.5 days post-PCI) and six-month follow-up in all patients in order to assess LV ejection fraction (EF). The MR was read by a physician blinded to treatment assignment.

Concomitant Medications:

Standard post-MI therapy, including aspirin, beta-blockers, statins, and angiotensin-converting enzyme (ACE) inhibitors

Principal Findings:

Bone marrow (mean 128 ml) was aspirated in patients in the active treatment arm at an average of 4.8 days post-PCI and 5.7 days postsymptom onset. Thrombolytic therapy was used in 10% of patients in the control arm and 14% of patients in the bone marrow arm (p=NS). There was also no difference in use of glycoprotein IIb/IIIa inhibitors (14% in each arm).

In the bone marrow arm, EF improved from 50.0% at baseline to 56.7% at six-month follow-up (mean 6.7% improvement), a significantly larger increase than in the control arm (51.3% at baseline vs. 50.0% at six months, mean 0.7% improvement; p=0.0026 for comparison in mean difference by treatment arm). Similar results were observed in the subgroup analysis by infarct location (left artery infarct, mean difference 5.1% between treatment arms, p=0.031; right infarct artery location, mean difference 8.3% between arms, p=0.026) and by gender.

There was no difference in percent angiographic restenosis at six-month follow-up between treatment arms (33% with bone marrow vs. 32% with control, p=0.88) or the percent with stenosis ≥50% (n=7 with bone marrow vs. n=4 with control, p=0.28). There were no deaths in the study.

Interpretation:

Among patients with ST elevation MI treated with successful PCI, treatment with intracoronary bone marrow transplant was associated with an improvement in the primary endpoint of LVEF at six months compared with control.

The present trial was the first randomized study of bone marrow transplant in post-MI patients. While the findings are positive, it should be noted that neither patients nor physicians were blinded to treatment assignment.

References:

Wollert KC, Meyer GP, Lotz J, et al. Intracoronary autologous bone-marrow cell transfer after myocardial infarction: the BOOST randomised controlled clinical trial. Lancet 2004;364:141-8.

Presented by Dr. Kai C. Wollert at the November 2003 American Heart Association Annual Scientific Sessions, Orlando, FL.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: Thrombolytic Therapy, Bone Marrow Transplantation, Myocardial Infarction, Follow-Up Studies, Hypokinesia, Constriction, Pathologic, Magnetic Resonance Spectroscopy, Angioplasty, Balloon, Coronary


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