Key result
Bone marrow cell therapy increases long-term mortality ~3-fold versus PCI alone in STEMI.
Why the study?
The study tested the hypothesis that pre-intervention levels of proinflammatory cytokines, anti-inflammatory cytokines, and angiogenic growth factors predict long-term clinical outcomes after ABMMC transplantation in primary STEMI patients.
RCT (n=62)
Open-label
Opaque sealed envelopes
No
Absolute Event Rate: 36% vs 12%
p-value: p=0.02
Caution against autologous bone marrow cell therapy post-STEMI; leaves open confirmation of harm in randomized trials.
AIM: The aim of the study was to test the hypothesis suggesting that the pre-intervention levels of proinflammatory cytokines, anti-inflammatory cytokines, and angiogenic growth factors predict the long-term clinical results of autologous bone marrow-derived mononuclear cell (ABMMC) transplantation in patients with primary ST elevation myocardial infarction (STEMI). METHODS AND RESULTS: From 2003 to 2006, a total of 62 patients with primary STEMI were enrolled in an open randomized study registered under the title ESTABOMA. Patients were randomized into two groups: group 1 included patients treated with percutaneous coronary intervention (PCI) and ABMMC transplantation (n = 28); group 2 comprised patients treated only with PCI (n = 34). Follow-up study was performed 7.96 ± 0.96 years after STEMI and involved physical examination, six-minute walk test, echocardiography, and determination of brain natriuretic peptide (BNP) levels. The total and cardiovascular mortality rates were higher in group 1 compared with group 2: 36% (n = 10) vs. 12% (n = 4) (p = 0.02) and 29% (n = 8) vs. 6% (n = 2) (p = 0.03), respectively. Lower levels of proinflammatory cytokines were observed in group 1 after PCI and ABMMC transplantation. Serum levels of FGF, VEGF, and IL-10, determined before PCI and ABMMC transplantation were prognostically significant long-term indicators of unfavorable course of CAD after STEMI.
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Ryabov et al. (2017) conducted an RCT in Primary ST elevation myocardial infarction (STEMI) (n=62). Autologous bone marrow mononuclear cell (ABMMC) transplantation and PCI vs. Percutaneous coronary intervention (PCI) alone was evaluated on Total mortality (p=0.02). Autologous bone marrow mononuclear cell transplantation in STEMI patients resulted in a higher long-term total mortality rate of 36% compared to 12% with PCI alone.
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