Poonam Velagapudi1, Mohit Turagam2, Dhaval Kolte3, Sahil Khera4, Omar Hyder3, Paul Gordon3, Herbert D Aronow3, Jane Leopold5, J Dawn Abbott3. 1. Structural Heart and Valve Center, Center for Interventional Vascular Therapy, Division of Cardiology, Columbia University Medical Center, New York, NY, United States. Electronic address: poonamchou@gmail.com. 2. Icahn School of Medicine at Mount Sinai, New York, NY, United States. 3. Brown University, Providence, RI, United States. 4. Massachusetts General Hospital, Boston, MA, United States. 5. Brigham and Women's Hospital, Boston, MA, United States.
Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: Three eligible randomized trials including 269 patients (placebo = 90, CD34+ = 179) were included. Dose of auto-CD34+ cells ranged from 5 × 104 to 5 × 105 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. CONCLUSION: 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.
BACKGROUND: Previous studies have demonstrated that intramyocardial humanCD34+ cells may relieve symptoms and improve clinical outcomes in chronic refractory angina unresponsive to optimal medical therapy or not amenable to revascularization. METHODS: We performed a meta-analysis of randomized controlled trials (RCTs) to evaluate the impact of humanCD34+ 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. RESULTS: Three eligible randomized trials including 269 patients (placebo = 90, CD34+ = 179) were included. Dose of auto-CD34+ cells ranged from 5 × 104 to 5 × 105 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. CONCLUSION: 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.
Authors: Radosław Kurzelowski; Kamil Barański; Guido Caluori; Wojciech Szot; Krzysztof Grabowski; Aleksandra Michalewska-Włudarczyk; Marcin Syzdół; Wacław Kuczmik; Anna Błach; Beata Ochała; Damian Hudziak; Jacek Wilczek; Krzysztof S Gołba; Zdenek Starek; Michał Tendera; Wojciech Wojakowski; Tomasz Jadczyk Journal: Postepy Kardiol Interwencyjnej Date: 2021-09-14 Impact factor: 1.426