Sex-Based Differences in Autologous Cell Therapy Trials in Patients With Acute Myocardial Infarction: Subanalysis of the ACCRUE Database

Frontiers in Cardiovascular Medicine

article

Paul M. Haller¹  Mariann Gyöngyösi¹  Lourdes Chacon-Alberty²  Camila Hochman-Mendez²  Luiz C. Sampaio³  Doris A. Taylor² 

[1] Department of Internal Medicine II, Division of Cardiology, Medical University of Vienna;Regenerative Medicine Research, Texas Heart Institute;Department of Advanced Cardiopulmonary Therapies and Transplantation, University of Texas (UT) Health Science Center

关键词: cell based therapy;    sex characteristics;    cardiovascular diseases;    clinical trials;    acute myocardial infarction;    sex differences;    cell therapy;   

DOI  :  10.3389/fcvm.2021.664277

学科分类：地球科学(综合)

来源: Frontiers

【 摘 要 】

Background: Sex-based differences are under-studied in cardiovascular trials as women are commonly underrepresented in dual sex studies, even though major sex-based differences in epidemiology, pathophysiology, and outcomes of cardiovascular disease have been reported. We examined sex-based differences in patient characteristics, outcome, and BM-CD34+ frequency of the ACCRUE (Meta-Analysis of Cell-based CaRdiac studies) database involving patients with acute myocardial infarction (AMI) randomized to autologous cell-based or control treatment. Methods: We compared baseline characteristics and 1-year follow-up clinical data: composite major adverse cardiac and cerebrovascular events (primary endpoint), and changes in left ventricular ejection fraction (LVEF), end-diastolic (EDV), and end-systolic volumes (ESV) (secondary efficacy endpoint) in women and men ( N = 1,252; 81.4% men). Secondary safety endpoints included freedom from hard clinical endpoints. Results: In cell-treated groups, women but not men had a lower frequency of stroke, AMI, and mortality than controls. The frequency of BM-CD34+ cells was significantly correlated with baseline EDV and ESV and negatively correlated with baseline LVEF in both sexes; a left shift in regression curve in women indicated a smaller EDV and ESV was associated with higher BM-CD34+ cells in women. Conclusions: Sex differences were found in baseline cardiovascular risk factors and cardiac function and in outcome responses to cell therapy.

【 授权许可】

CC BY