Key result
Autologous CD34+ cell therapy reduced angina frequency at 24 months (p=0.03) and showed a trend toward lower MACE rates compared to placebo (16.2% and 21.8% vs 33.9%; p=0.08).
Why the study?
Does autologous CD34+ cell therapy improve angina and reduce MACE in patients with class III-IV refractory angina without revascularization options?
RCT (n=167)
double-blind
randomized
Does autologous CD34+ cell therapy improve angina and reduce MACE in patients with class III-IV refractory angina without revascularization options?
p-value: p=0.08
Autologous CD34+ cell therapy provides persistent improvement in angina frequency at 2 years and a trend toward reduced MACE in patients with no-option refractory angina.
Supports sustained angina relief at 2 years in refractory angina; extends Phase II RCT data but leaves MACE benefit inconclusive.
An increasing number of patients have refractory angina despite optimal medical therapy and are without further revascularization options. Preclinical studies indicate that human CD34 + stem cells can stimulate new blood vessel formation in ischemic myocardium, improving perfusion and function. In ACT34-CMI ( N = 167), patients treated with autologous CD34 + stem cells had improvements in angina and exercise time at 6 and 12 months compared to placebo; however, the longer-term effects of this treatment are unknown. ACT34 was a phase II randomized, double-blind, placebo-controlled clinical trial comparing placebo, low dose (1 × 10 5 CD34/kg body weight), and high dose (5 × 10 5 CD34/kg) using intramyocardial delivery into the ischemic zone following NOGA ® mapping. To obtain longer-term safety and efficacy in these patients, we compiled data of major adverse cardiac events (MACE; death, myocardial infarction, acute coronary syndrome, or heart failure hospitalization) up to 24 months as well as angina and quality of life assessments in patients who consented for 24-month follow-up. A total of 167 patients with class III–IV refractory angina were randomized and completed the injection procedure. The low-dose-treated patients had a significant reduction in angina frequency ( p = 0.02, 0.035) and improvements in exercise tolerance testing (ETT) time ( p = 0.014, 0.017) compared to the placebo group at 6 and 12 months. At 24 months, patients treated with both low-and high-dose CD34 + cells had significant reduction in angina frequency ( p = 0.03). At 24 months, there were a total of seven deaths (12.5%) in the control group versus one (1.8%) in the low-dose and two (3.6%) in the high-dose ( p = 0.08) groups. At 2 years, MACE occurred at a rate of 33.9%, 21.8%, and 16.2% in control, low-, and high-dose patients, respectively ( p = 0.08). Autologous CD34 + cell therapy was associated with persistent improvement in angina at 2 years and a trend for reduction in mortality in no-option patients with refractory angina.
No takes yet. Share an insight, caveat, or question.
Henry et al. (2016) conducted an RCT in refractory angina (n=167). Autologous CD34+ cell therapy vs. placebo was evaluated on Major adverse cardiac events (MACE) at 24 months (p=0.08). Autologous CD34+ cell therapy reduced angina frequency at 24 months (p=0.03) and showed a trend toward lower MACE rates compared to placebo (16.2% and 21.8% vs 33.9%; p=0.08).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: