gms | German Medical Science

MAINZ//2011: 56. GMDS-Jahrestagung und 6. DGEpi-Jahrestagung

Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e. V.
Deutsche Gesellschaft für Epidemiologie e. V.

26. - 29.09.2011 in Mainz

Meta-Analysis with Meta-Regression of Regenerative Medicine Trials

Meeting Abstract

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  • Änne Glass - Institute for Biostatistics and Informatics in Medicine and Ageing Research, Medical Faculty, University of Rostock, Rostock
  • Peter Donndorf - Department of Cardiac Surgery, Medical Faculty, University of Rostock, Rostock
  • Günther Kundt - Institute for Biostatistics and Informatics in Medicine and Ageing Research, Medical Faculty, University of Rostock, Rostock

Mainz//2011. 56. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie (gmds), 6. Jahrestagung der Deutschen Gesellschaft für Epidemiologie (DGEpi). Mainz, 26.-29.09.2011. Düsseldorf: German Medical Science GMS Publishing House; 2011. Doc11gmds037

DOI: 10.3205/11gmds037, URN: urn:nbn:de:0183-11gmds0376

Veröffentlicht: 20. September 2011

© 2011 Glass et al.
Dieser Artikel ist ein Open Access-Artikel und steht unter den Creative Commons Lizenzbedingungen (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.de). Er darf vervielfältigt, verbreitet und öffentlich zugänglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.


Gliederung

Text

Objectives: Regenerative medicine trials have suggested that intramyocardial bone marrow stem cell (BMSC) transplantation combined with coronary artery bypass surgery (CABG) might improve left ventricular (LV) function, and thus prove to be a new therapeutic option for patients with endstage ischemic heart disease.

To quantify the overall treatment effect of two important functional parameters we conducted a meta-analysis of relevant studies, regarding efficacy and safety of BMSC transplantation during CABG [1].

Methods: Database searches (PUBMED, MEDLINE, Cochrane trials register, ClinicalTrials.gov) revealed 4 RCT’s and 2 cohort studies to include.

The meta-analysis (STATA 9.0) was conducted for functional parameters LV ejection fraction (LVEF) and LV end-diastolic volume (LVEDV) for both follow-up and change, and it was stratified by the difference between BMSC and control group. Each mean difference was weighted by the inverse of variance, before being pooled with either the fixed or random effects model, depending on I-squared and Cochran’s χ2-test of homogeneity [2]. In case of heterogeneity a meta-regression analysis was added. To test significance of the overall effect we performed the z-test.

The presence of publication bias was assessed by funnel plots, Begg’s rank correlation test (τ) and Eggers’s weighted regression method.

For safety, relative risks [3] of two major adverse cardiovascular events (MACE) parameters, namely ventricular arrhythmias (RRVA) and a composite of cardiovascular events (RRCE), were meta-analyzed.

Results: Compared to the control group, the BMSC group showed significant improvement of LVEFfollow-up (7.20%, 95%CI: 5.38 to 9.02, p<0.001) and LVEFchange (5.40%, 95%CI: 1.36 to 9.44, p=0.009) [1]. Furthermore, a reduction of LVEDVfollow-up (-14.28 ml, 95%CI: -28.87 to 0.32, p=0.055) and a positive LVEDVchange (9.55 ml, 95%CI: -2.82 to 21.92, p=0.13) [1] can be reported in the BMSC group. Both MACE parameters were not significantly different [1].

Conclusions: BMSC transplantation in combination with CABG is associated with improvements of functional parameters in patients with chronic ischemic heart disease. Surgical intramyocardial BMSC transplantation appears to be safe.


References

1.
Donndorf P, Kundt G, Kaminski A, Yerebakan C, Liebold A, Steinhoff G, Glass A. J Thorac Cardiovasc Surg. 2011.
2.
Higgins. Quality & Safety in Health Care. 2003;327(7414):557.
3.
Armitage. Statistical methods in medical research. 4th Edition. 2002.