Excerpt

Cardiovascular disease is the leading cause of mortality for women in the United States. According to the American Heart Association (AHA), approximately one in three female adults have some form of cardiovascular disease. AHA suggests there is evidence showing that women at risk for coronary artery disease (CAD) are less often referred for the appropriate diagnostic test than are men. Coronary anatomy and pathology have traditionally been defined and identified by coronary angiography, a procedure that is indicated in patients who have chest pain and are at high risk for CAD. For intermediate-risk patients, clinicians have a wide range of noninvasive technologies (NITs) to choose from that can assess functional status (i.e., ischemia or no ischemia) or visualize anatomic abnormalities (i.e., no CAD, nonobstructive CAD, or obstructive CAD). Functional modalities include stress electrocardiography (ECG); stress echocardiography (ECHO); and stress radionuclide myocardial perfusion imaging, including single-proton emission computed tomography (SPECT) and positron emission tomography (PET). Anatomic modalities include stress myocardial perfusion and wall-motion cardiac magnetic resonance (CMR) imaging and coronary computed tomography angiography (coronary CTA). The comparative safety and accuracy of these NITs in women was uncertain, although substantial data exists for populations combining men and women, and for mixed populations of known and no known CAD.

In 2012, a Comparative Effectiveness Review (CER), “Noninvasive Technologies for the Diagnosis of Coronary Artery Disease in Women,” evaluated the diagnostic accuracy and risks of NITs in women with symptoms suspicious for CAD, including assessing predictors affecting test accuracy, and the ability of NITs to provide risk stratification and prognostic information, inform decisionmaking about treatment options, and affect clinical outcomes.

A total of 104 comparative studies (110 articles) were included. For women with no known CAD, the summary of accuracy for each NIT modality compared with coronary angiography was ECG (29 studies): sensitivity 62 percent, specificity 68 percent; ECHO (14 studies): sensitivity 79 percent, specificity 83 percent; SPECT (14 studies): sensitivity 81 percent, specificity 78 percent; CMR (5 studies): sensitivity 72 percent, specificity 84 percent; and CTA (5 studies): sensitivity 94 percent, specificity 87 percent. Compared with men evaluated in the same studies, in women ECG and coronary CTA modalities were both less sensitive and less specific. The ECHO and SPECT modalities, although less sensitive, appeared to be more specific in women. The lower specificity of the ECG modality in women was the only statistically significant difference. Strength of evidence was high for ECG, ECHO, and SPECT, and was low for CMR and coronary CTA compared with coronary angiography in women. Eleven comparative studies examined predictors of diagnostic accuracy in women such as postmenopausal status, race/ethnicity, heart size, beta blocker use, and pretest probability; insufficient evidence was available to draw conclusions about predictors that affect accuracy. Eight studies assessed risk stratification and prognostic factors, two studies assessed treatment decisionmaking, and four studies provided comparative clinical outcomes but provided insufficient evidence on the comparative effectiveness of NITs to provide risk stratification, prognostic information, treatment decisionmaking, or impact on clinical outcomes in women. Thirteen comparative studies reported risks. Of these, four studies of coronary CTA showed a higher mean effective radiation dose and attributable risk of cancer incidence in women compared with men; however, radiation safety issues were not discussed in other NIT modalities with radiation exposure. Thus, there was insufficient evidence regarding the comparative risks of various NIT modalities in women.

Given the clinical and economic importance of noninvasive testing for CAD in women, the ongoing investment in NIT research, and the remaining areas of uncertainty, we sought to create a prioritized research agenda that would represent the interests of diverse stakeholders and allow the remaining areas of uncertainty to be addressed.

Contents

• Preface
• Acknowledgments
• Stakeholders
• Executive Summary
• Background
• Methods
  • Overview
  • Analytic Framework
  • Initial List of Research Needs
  • Creation of Stakeholder Group
  • Expansion of Research Gaps
  • Review of Current Literature
  • Research Prioritization
• Results
• Discussion
• Conclusions
• References
• Abbreviations
• Appendix A Exact Search Strings
• Appendix B Table of Research Priorities Linked to Recent Publications and Ongoing Studies
• Appendix C Criteria for Research Prioritization

Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services¹, Contract No. 290-2007-10066-I, Prepared by: Duke Evidence-based Practice Center, Durham, NC

Suggested citation:

Sanders GD, Patel MR, Chatterjee R, Ross AK, Bastian LA, Coeytaux RR, Heidenfelder BL, Musty MD, Dolor, RJ. Noninvasive Technologies for the Diagnosis of Coronary Artery Disease in Women: Future Research Needs. Future Research Needs Paper No. 41. (Prepared by the Duke Evidence-based Practice Center under Contract No. 290-2007-10066-I). AHRQ Publication No. 13-EHC072-EF. Rockville, MD: Agency for Healthcare Research and Quality. February 2013. www.effectivehealthcare.ahrq.gov/reports/final.cfm.

This report is based on research conducted by the Duke Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2007-10066-I). The findings and conclusions in this document are those of the author(s), who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.

The information in this report is intended to help health care researchers and funders of research make well-informed decisions in designing and funding research and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of scientific judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical research and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances.

None of the investigators have any affiliation or financial involvement that conflicts with the material presented in this report.

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