Journal of Womens Health, Issues and Care ISSN: 2325-9795

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Editorial, J Womens Health Issues Care Vol: 2 Issue: 2

Women in Cardiovascular Clinical Trials

Wesley T. O’Neal1, Taylor E. Edwards1, Chelsea S. DiMartino1 and Jimmy T. Efird1,2*
1Department of Cardiovascular Sciences, East Carolina Heart Institute, Greenville, NC, USA
2Center for Health Disparities Research, Brody School of Medicine, East Carolina University, Greenville, NC, USA
Corresponding author : Jimmy T. Efird
Center for Health Disparities Research, Brody School of Medicine, East Carolina University, 115 Heart Drive, Greenville, NC 27834, USA
Tel:
+1 650 248 8282; Fax: +1 252 744 5539
E-mail: [email protected]
Received: March 11, 2013 Accepted: March 12, 2013 Published: March 15, 2013
Citation: O’Neal et al. (2013) Women in Cardiovascular Clinical Trials. J Womens Health, Issues Care 2:2 doi: 10.4172/2325-9795.1000e106

Abstract

Women in Cardiovascular Clinical Trials

Between 1980 and 2000, the age-adjusted death rate due to coronary heart disease (CHD) decreased by 48%. The optimization of medical therapies (OMT) and revascularization procedures such as percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) has accounted for 50% of the decline. While mortality rates for CHD have not declined equally for men and women, recent randomized clinical trials have not addressed gender differences regarding the efficacy of therapeutic interventions. Historically, women have been underrepresented in clinical trials of cardiovascular disease.

Keywords:

Between 1980 and 2000, the age-adjusted death rate due to coronary heart disease (CHD) decreased by 48% [1]. The optimization of medical therapies (OMT) and revascularization procedures such as percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) has accounted for 50% of the decline. While mortality rates for CHD have not declined equally for men and women, recent randomized clinical trials have not addressed gender differences regarding the efficacy of therapeutic interventions [2]. Historically, women have been underrepresented in clinical trials of cardiovascular disease.
The COURAGE study was a randomized trial of 2,287 patients with evidence of myocardial ischemia and significant coronary artery disease (CAD) [3]. Patients in this trial were randomized to receive OMT or PCI with OMT. While women who had PCI tended to live longer than men, the result was not statistically significant due to a low number of female participants (15%). BARI-2D was a prospective trial of 2,368 patients with both type 2 diabetes and documented coronary disease [4]. Similar to the COURAGE study, patients were randomized to receive OMT or immediate revascularization including PCI or CABG. OMT was found to be an appropriate initial treatment for stable CAD among type 2 diabetics. However, it is uncertain if women and men benefited equally due to the small percentage of female participants (~30%) in the study.
PCI also has been compared with CABG to determine the most effective revascularization technique. In the SYNTAX trial, patients with multi-vessel CAD and high SYNTAX scores receiving CABG lived longer than those treated with PCI [5]. Additionally, FREEDOM has shown CABG to be the revascularization method of choice among diabetics [6]. Due to the small number of female participants in SYNTAX (~22%) and FREEDOM (~29%), neither study was able to identify gender-specific differences in mortality.
The inability of randomized trials to identify gender differences regarding revascularization techniques highlights the importance of large observational registries. ASCERT was an observational study to examine the effectiveness of CABG compared with PCI using data from the Society of Thoracic Surgeons (STS) and the American College of Cardiology Foundation (ACCF) databases [7]. This study showed a survival advantage among women that received CABG compared with PCI (HR=0.76, 95%CI=0.71-81). The large sample size (N=189,793) and greater percentage of female participants (37.3%) allowed this study to report gender-specific mortality rates that others randomized trials have been unable to identify.
The evaluation of outcomes in large samples representative of the general population enables the comparison between specific groups, as evidenced by the ASCERT study. Generally, randomized trials are considered to be the best evidence when comparing the efficacy of treatment groups while retrospective studies are believed to be less convincing [8]. However, clinical trials have known barriers to patient participation and also may not generalize to many populations due to narrow selection criteria. For example, the poor, minorities, and females often are underrepresented in many clinical trials [9].
Gender-specific differences in the efficacy of current treatments for CAD need to be further explored. Recent randomized trials have failed to address possible gender differences. With the projected increases in the prevalence of CHD, future clinical trials should aim to include a larger number of female participants. This editorial emphasizes the importance of enrolling an adequate number of female participants in clinical trials to determine the most effective treatment modalities among women.

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