Long-term results after intracoronary injection of autologous mononuclear bone marrow cells in acute myocardial infarction: the ASTAMI randomised, controlled study
Long-term results after intracoronary injection of autologous mononuclear bone marrow cells in acute myocardial infarction: the ASTAMI randomised, controlled study
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DOI：
10.1136/hrt.2009.178913
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发表时间：
2009-12-15
期刊：
影响因子：
5.7
通讯作者：
Aakhus, S.
中科院分区：
文献类型：
--
作者：
Beitnes, J. O.;Hopp, E.;Aakhus, S.
目的：研究急性心肌梗死（AMI）患者冠状动脉内注射自体骨髓单个核细胞（mBMCs）后的长期安全性和有效性。设计：随机对照试验。设置：挪威奥斯陆的两家大学医院。患者：急性心肌梗死自体干细胞移植（ASTAMI）研究的患者在入选后3年重新评估。干预措施：100例前壁ST段抬高型心肌梗死患者接受急性经皮冠状动脉介入治疗（PCI），随机分为接受或不接受mBMCs冠状动脉内注射组（n = 50）。运动能力（峰值VO 2）和生活质量（次要）的变化。结果：两组的不良临床事件发生率均较低且相同。随访期间超声心动图或磁共振成像（MRI）显示的左室整体收缩功能变化在两组之间无显著差异。在运动试验中，接受mBMC治疗的患者从2-3周至3年的运动时间有较大的改善（1.5分钟vs 0.6分钟，p=0.05），但峰值氧耗量的变化没有差异（3.0 ml/kg/min vs 3.1 ml/kg/min，p=0.75）。发现mBMC组的运动时间略有改善，但在细胞治疗3年后没有发现其他治疗效果。
Objective: To investigate long-term safety and efficacy after intracoronary injection of autologous mononuclear bone marrow cells (mBMCs) in acute myocardial infarction (AMI).Design: Randomised, controlled trial.Setting: Two university hospitals in Oslo, Norway.Patients: Patients from the Autologous Stem cell Transplantation in Acute Myocardial Infarction (ASTAMI) study were re-assessed 3 years after inclusion.Interventions: 100 patients with anterior wall ST-elevation myocardial infarction treated with acute percutaneous coronary intervention (PCI) were randomised to receive intracoronary injection of mBMCs (n=50) or not (n=50).Main outcome measures: Change in left ventricular (LV) ejection fraction (primary). Change in exercise capacity (peak VO2) and quality of life (secondary). Infarct size (additional aim), and safety.Results: The rates of adverse clinical events in the groups were low and equal. There were no significant differences between groups in change of global LV systolic function by echocardiography or magnetic resonance imaging (MRI) during the follow-up. On exercise testing, the mBMC-treated patients had larger improvement in exercise time from 2-3 weeks to 3 years (1.5 minutes vs 0.6 minutes, p=0.05), but the change in peak oxygen consumption did not differ (3.0 ml/kg/min vs 3.1 ml/kg/min, p=0.75).Conclusion: The results indicate that intracoronary mBMC treatment in AMI is safe in the long term. A small improvement in exercise time in the mBMC group was found, but no other effects of treatment could be identified 3 years after cell therapy.