Autologous CD34+ cell therapy improves exercise capacity, angina frequency and reduces mortality in no-option refractory angina: a patient-level pooled analysis of randomized double-blinded trials
Authors' conclusion
Treatment with auto-CD34+ cells resulted in clinically meaningful durable improvements in TET and AF at 3-, 6- and 12-months, as well as a reduction in 24-month mortality in this patient-level meta-analysis.
Study context
- Population
- Patients with no-option refractory angina
- Participants
- 304 patients3 RCTs
- Comparison
- Intramyocardial auto-CD34+ cells vs intramyocardial placebo
- Outcome
- Total exercise time (TET), angina frequency and MACE
Methodological detailsdouble-blind, placebo-controlled, 3 trials (Phase I, Phase II ACT-34 and extension, Phase III RENEW)
- Double-blind
- Placebo-controlled
- 3 trials (Phase I, Phase II ACT-34 and extension, Phase III RENEW)
Pooled result
As reported in the abstract
3, 6 and 12 months
Auto-CD34+ vs PlaceboDifference, s (95% CI)P value
TET, 6 months
49.5(9.3–89.7)
P = 0.016- Total exercise time (TET), 3 months
- difference 46.6 s (95% CI 13.0 s-80.3 s); P = 0.007
- TET, 12 months
- difference 44.7 s (95% CI - 2.7 s-92.1 s); P = 0.065
- Angina frequency, 3 months
- relative frequency 0.78 (95% CI 0.63–0.98); P = 0.032
- Angina frequency, 6 months
- relative frequency 0.66 (95% CI 0.48–0.91); P = 0.012
- Angina frequency, 12 months
- relative frequency 0.58 (95% CI 0.38–0.88); P = 0.011
Further pooled results
Mortality and major adverse cardiac events (MACE) · 24 months
- Mortality significantly decreased with auto-CD34+
- 12.1% vs. 2.5%; P = 0.0025
- MACE numerically reduced with auto-CD34+
- 38.9% vs. 30.0; P = 0.14
Original publication
Autologous CD34+ cell therapy improves exercise capacity, angina frequency and reduces mortality in no-option refractory angina: a patient-level pooled analysis of randomized double-blinded trials. Eur Heart J. Published 5 January 2018. doi:10.
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