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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.

Publication ,  Journal Article
Henry, TD; Losordo, DW; Traverse, JH; Schatz, RA; Jolicoeur, EM; Schaer, GL; Clare, R; Chiswell, K; White, CJ; Fortuin, FD; Kereiakes, DJ ...
Published in: Eur Heart J
June 14, 2018

AIMS: Autologous CD34+ (auto-CD34+) cells represent an attractive option for the treatment of refractory angina. Three double-blinded randomized trials (n = 304) compared intramyocardial (IM) auto-CD34+ cells with IM placebo injections to affect total exercise time (TET), angina frequency (AF), and major adverse cardiac events (MACE). Patient-level data were pooled from the Phase I, Phase II ACT-34, ACT-34 extension, and Phase III RENEW trials to determine the efficacy and safety of auto-CD34+ cells. METHODS AND RESULTS: Treatment effects for TET were analysed using an analysis of covariance mixed-effects model and for AF using Poisson regression in a log linear model with repeated measures. The Kaplan-Meier rate estimates for MACE were compared using the log-rank test. Autologous CD34+ cell therapy improved TET by 46.6 s [3 months, 95% confidence interval (CI) 13.0 s-80.3 s; P = 0.007], 49.5 s (6 months, 95% CI 9.3-89.7; P = 0.016), and 44.7 s (12 months, 95% CI - 2.7 s-92.1 s; P = 0.065). The relative frequency of angina was 0.78 (95% CI 0.63-0.98; P = 0.032), 0.66 (0.48-0.91; P = 0.012), and 0.58 (0.38-0.88; P = 0.011) at 3-, 6- and 12-months in auto-CD34+ compared with placebo patients. Results remained concordant when analysed by treatment received and when confined to the Phase III dose of 1 × 105 cells/kg. Autologous CD34 + cell therapy significantly decreased mortality (12.1% vs. 2.5%; P = 0.0025) and numerically reduced MACE (38.9% vs. 30.0; P = 0.14) at 24 months. 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.

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Published In

Eur Heart J

DOI

EISSN

1522-9645

Publication Date

June 14, 2018

Volume

39

Issue

23

Start / End Page

2208 / 2216

Location

England

Related Subject Headings

  • Transplantation, Autologous
  • Stem Cell Transplantation
  • Randomized Controlled Trials as Topic
  • Myocardium
  • Mortality
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate
  • Injections, Intramuscular
  • Humans
 

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Henry, T. D., Losordo, D. W., Traverse, J. H., Schatz, R. A., Jolicoeur, E. M., Schaer, G. L., … Povsic, T. J. (2018). 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, 39(23), 2208–2216. https://doi.org/10.1093/eurheartj/ehx764
Henry, Timothy D., Douglas W. Losordo, Jay H. Traverse, Richard A. Schatz, E Marc Jolicoeur, Gary L. Schaer, Robert Clare, et al. “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 39, no. 23 (June 14, 2018): 2208–16. https://doi.org/10.1093/eurheartj/ehx764.
Henry TD, Losordo DW, Traverse JH, Schatz RA, Jolicoeur EM, Schaer GL, Clare R, Chiswell K, White CJ, Fortuin FD, Kereiakes DJ, Zeiher AM, Sherman W, Hunt AS, Povsic TJ. 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. 2018 Jun 14;39(23):2208–2216.
Journal cover image

Published In

Eur Heart J

DOI

EISSN

1522-9645

Publication Date

June 14, 2018

Volume

39

Issue

23

Start / End Page

2208 / 2216

Location

England

Related Subject Headings

  • Transplantation, Autologous
  • Stem Cell Transplantation
  • Randomized Controlled Trials as Topic
  • Myocardium
  • Mortality
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate
  • Injections, Intramuscular
  • Humans