Meta-Analysis of Percutaneous Endomyocardial Cell Therapy in Patients with Ischemic Heart Failure by Combination of Individual Patient Data (IPD) of ACCRUE and Publication-Based Aggregate Data

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  • Mariann Gyöngyösi
  • Evgeny Pokushalov
  • Aleksander Romanov
  • Emerson Perin
  • Joshua M. Hare
  • Jens Kastrup
  • Francisco Fernández-Avilés
  • Ricardo Sanz-Ruiz
  • Anthony Mathur
  • Wojcieh Wojakowski
  • Enca Martin-Rendon
  • Noemi Pavo
  • Imre J. Pavo
  • Rayyan Hemetsberger
  • Denise Traxler
  • Andreas Spannbauer
  • Paul M. Haller

Individual patient data (IPD)-based meta-analysis (ACCRUE, meta-analysis of cell-based cardiac studies, NCT01098591) revealed an insufficient effect of intracoronary cell-based therapy in acute myocardial infarction. Patients with ischemic heart failure (iHF) have been treated with re-parative cells using percutaneous endocardial, surgical, transvenous or intracoronary cell delivery methods, with variable effects in small randomized or cohort studies. The objective of this meta-analysis was to investigate the safety and efficacy of percutaneous transendocardial cell therapy in patients with iHF. Two investigators extracted the data. Individual patient data (IPD) (n = 8 studies) and publication-based (n = 10 studies) aggregate data were combined for the meta-analysis, includ-ing patients (n = 1715) with chronic iHF. The data are reported in accordance with PRISMA guide-lines. The primary safety and efficacy endpoints were all-cause mortality and changes in global ejection fraction. The secondary safety and efficacy endpoints were major adverse events, hospitalization and changes in end-diastolic and end-systolic volumes. Post hoc analyses were performed using the IPD of eight studies to find predictive factors for treatment safety and efficacy. Cell therapy was significantly (p < 0.001) in favor of survival, major adverse events and hospitalization during follow-up. A forest plot analysis showed that cell therapy presents a significant benefit of in-creasing ejection fraction with a mean change of 2.51% (95% CI: 0.48; 4.54) between groups and of significantly decreasing end-systolic volume. The analysis of IPD data showed an improvement in the NYHA and CCS classes. Cell therapy significantly decreased the end-systolic volume in male patients; in patients with diabetes mellitus, hypertension or hyperlipidemia; and in those with pre-vious myocardial infarction and baseline ejection fraction ≤45%. The catheter-based transendocar-dial delivery of regenerative cells proved to be safe and effective for improving mortality and cardiac performance. The greatest benefit was observed in male patients with significant atheroscle-rotic co-morbidities.

Original languageEnglish
Article number3205
JournalJournal of Clinical Medicine
Volume11
Issue number11
ISSN2077-0383
DOIs
Publication statusPublished - 2022

Bibliographical note

Publisher Copyright:
© 2022 by the authors. Li-censee MDPI, Basel, Switzerland.

    Research areas

  • ACCRUE, cell-based regeneration therapy, human clinical trials, meta-analysis, percutaneous transendocardial cell delivery, stem cells

ID: 321644178