Abstract
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.
Highlights
Cardiovascular disease (CVD), often thought of as a male disease, is the leading cause of death for women in the United States, killing more women than all forms of cancer combined [1, 2]
The frequency of bone marrow (BM)-CD34+ cells was significantly correlated with baseline end-diastolic volume (EDV) and end-systolic volumes (ESV) and negatively correlated with baseline left ventricular ejection fraction (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
Sex differences were found in baseline cardiovascular risk factors and cardiac function and in outcome responses to cell therapy
Summary
Cardiovascular disease (CVD), often thought of as a male disease, is the leading cause of death for women in the United States, killing more women than all forms of cancer combined [1, 2]. For most CVDs, the epidemiology, pathophysiology, response to treatment, and outcomes differ for men and women [3]. Despite substantial improvements in cardiovascular death rates over the last decade, women have a worse prognosis after acute myocardial infarction (AMI) than men [5]. These disparities may be attributed in part to sex differences with respect to the biological variance in gene expression and are manifested through various biochemical and cellular processes, including the myocardial adaption to disease [6]. When women receive treatment based on the data gained in clinical studies comprising primarily men, unanticipated events may occur related to sex-specific differences [10]. 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
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