Velagapudi Poonam, Turagam Mohit, Kolte Dhaval, Khera Sahil, Hyder Omar, Gordon Paul, Aronow Herbert D, Leopold Jane, Abbott J Dawn
Structural Heart and Valve Center, Center for Interventional Vascular Therapy, Division of Cardiology, Columbia University Medical Center, New York, NY, United States.
Icahn School of Medicine at Mount Sinai, New York, NY, United States.
Cardiovasc Revasc Med. 2019 Mar;20(3):215-219. doi: 10.1016/j.carrev.2018.05.018. Epub 2018 Jun 5.
Previous studies have demonstrated that intramyocardial human CD34+ cells may relieve symptoms and improve clinical outcomes in chronic refractory angina unresponsive to optimal medical therapy or not amenable to revascularization.
We performed a meta-analysis of randomized controlled trials (RCTs) to evaluate the impact of human CD34+ cells compared with placebo in chronic refractory angina. Primary efficacy outcomes in our analysis were angina frequency and exercise time. Primary safety outcomes included major adverse cardiovascular events such as myocardial infarction (MI), stroke and death.
Three eligible randomized trials including 269 patients (placebo = 90, CD34+ = 179) were included. Dose of auto-CD34+ cells ranged from 5 × 10 to 5 × 10 cells/kg. Follow-up ranged from 6 to 24 months. In a pooled analysis, administration of CD34+ cells decreased the risk of all-cause mortality [OR 0.24, 95% CI (0.08-0.73), p = 0.01], reduced angina frequency [mean difference -2.91, 95% CI (-4.57 to -1.25), p = 0.0006] and improved exercise time [mean difference 58.62 s, 95% CI (21.19 to 96.06), p = 0.02] compared with control group. However, there was no significant difference in the risk of myocardial infarction (MI) and stroke between groups.
In a meta-analysis, intra-myocardial CD34+ cell therapy was superior to placebo in improving risk of all - cause mortality, angina frequency with an increase in exercise time, without a significant increase in adverse events. This analysis supports further trials of CD34+ cell therapy for ischemic heart disease.
既往研究表明，心肌内注射人CD34+细胞可缓解症状，并改善对最佳药物治疗无反应或不适合血运重建的慢性难治性心绞痛患者的临床结局。
我们对随机对照试验（RCT）进行了荟萃分析，以评估人CD34+细胞与安慰剂相比对慢性难治性心绞痛的影响。我们分析的主要疗效指标为心绞痛发作频率和运动时间。主要安全性指标包括心肌梗死（MI）、中风和死亡等主要不良心血管事件。
纳入了3项符合条件的随机试验，共269例患者（安慰剂组=90例，CD34+细胞组=179例）。自体CD34+细胞剂量范围为5×10⁶至5×10⁷个细胞/kg。随访时间为6至24个月。在汇总分析中，与对照组相比，注射CD34+细胞可降低全因死亡率风险[比值比（OR）0.24，95%置信区间（CI）（0.08 - 0.73），p = 0.01]，减少心绞痛发作频率[平均差值 -2.91，95% CI（-4.57至-1.25），p = 0.0006]，并改善运动时间[平均差值58.62秒，95% CI（21.19至96.06），p = 0.02]。然而，两组之间心肌梗死（MI）和中风风险无显著差异。
在荟萃分析中，心肌内CD34+细胞治疗在改善全因死亡率风险、心绞痛发作频率及增加运动时间方面优于安慰剂，且不良事件无显著增加。该分析支持进一步开展CD34+细胞治疗缺血性心脏病的试验。
