Guideline:
Role of noninvasive testing in the clinical evaluation of women with suspected coronary artery disease
Bibliographic Source(s)
- Mieres JH Shaw LJ Arai A Budoff MJ Flamm SD Hundley WG Marwick TH Mosca L Patel AR Quinones MA Redberg RF Taubert KA Taylor AJ Thomas GS Wenger NK. Role of noninvasive testing in the clinical evaluation of women with suspected coronary artery disease: consensus statement from the Cardiac Imaging Committee Council on Clinical Cardiology and the Cardiovascular Imaging and Intervention [trunc]. Circulation 2005 Feb 8;111(5):682-96. [168 references] PubMed
Guideline Status
This is the current release of the guideline.
Guideline Category
Diagnosis
Evaluation
Risk Assessment
Intended Users
Physicians
Guideline Objective(s)
To provide a synopsis of available evidence about noninvasive cardiac testing modalities in the diagnosis and risk assessment of both the symptomatic and asymptomatic woman patient with suspected coronary artery disease (CAD)
Target Population
Women with suspected coronary artery disease (CAD)
Interventions and Practices Considered
Risk Assessment/Diagnosis/Evaluation
- Resting 12-lead electrocardiography (ECG)
- Exercise electrocardiography (treadmill test)
- Stress echocardiography (dobutamine or exercise)
- Cardiac radionuclide imaging: stress myocardial gated perfusion single-photon emission computed tomography (SPECT) imaging (exercise or pharmacological stress)
Major Outcomes Considered
- Predictive value of diagnostic tests
- Sensitivity and specificity of diagnostic tests
- Prognostic value of tests
- Incidence of false-negative and false-positive results
- Survival rate
- Coronary artery calcium
Methods Used to Collect/Select Evidence
Searches of Electronic Databases
Description of Methods used to Collect/Select the Evidence
Guideline developers searched English language manuscripts including original manuscripts and meta-analyses published from 1970 to 2005 that adhered to the American College of Cardiology/American Heart Association (ACC/AHA) guidelines.
Number of Source Documents
200
Methods Used to Assess the Quality and Strength of the Evidence
Expert Consensus
Rating Scheme for the Strength of the Evidence
Not applicable
Methods Used to Analyze the Evidence
Review
Description of the Methods Used to Analyze the Evidence
Not stated
Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations
Not stated
Rating Scheme for the Strength of the Recommendations
Not applicable
Cost Analysis
A formal cost analysis was not performed and published cost analyses were not reviewed.
Method of Guideline Validation
Peer Review
Description of Method of Guideline Validation
Expert peer review of American Heart Association (AHA) Scientific Statements is conducted at the AHA National Center. For more on AHA statements and guidelines development visit http://www.americanheart.org/presenter.jhtml?identifier=3023366.
This statement was approved by the AHA Science Advisory and Coordinating Committee on December 23 2004.
Major Recommendations
Recommendations for Noninvasive Testing in Women with Suspected Coronary Artery Disease (CAD)
For women with a normal resting electrocardiography (ECG) and good exercise tolerance evidence supports the recommendation from the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for a routine exercise treadmill test as the initial test for the evaluation of suspected CAD. Combining parameters such as exercise capacity and heart rate changes with the traditional evaluation of ST-segment changes improves the prognostic accuracy of the exercise treadmill test making it a cost-efficient modality to use in this group of women (see Figure 1 in the original guideline document).
The indications for cardiac imaging in symptomatic cohorts of women are summarized in Figure 2 in the original guideline document. Cardiac imaging is recommended for symptomatic women with established CAD. Current evidence and practice guidelines recommend cardiac imaging for women with suspected CAD with an abnormal resting 12-lead ECG. More widespread use may be justified but data are insufficient to support the primary use of imaging tests in all female patients. Cardiac imaging is recommended for women with an indeterminate or intermediate-risk exercise ECG test as well as those with an intermediate-risk Duke treadmill score.
Although not considered in the current ACC/AHA guidelines diabetic women merit special consideration and are included in the present statement as candidates for cardiac imaging because they have a risk of cardiovascular death that is up to 8-fold higher than that of non-diabetic women. As outlined in Figure 2 in the original guideline document additional candidates for cardiac imaging include other intermediate- to high-risk groups with functional impairment that are suitable for pharmacological stress. On the basis of a growing body of evidence cardiac imaging via contemporary techniques of stress echocardiography or gated single-photon emission computed tomography (SPECT) myocardial perfusion imaging provides accurate diagnostic and prognostic information for women with suspected ischemic symptoms. Additional special populations of women who also may be at risk include women with the metabolic syndrome and those with polycystic ovary syndrome although definitive imaging evidence is not available.
On the basis of existing evidence the asymptomatic woman with a calcium score >400 has an annualized risk of CAD death or myocardial infarction (MI) of approximately 2% and should be considered at high cardiac risk. This recommendation is supported by the recently published AHA guidelines on CAD prevention in women which noted that a 2% risk of major adverse cardiac events places a patient at high risk. Thus many experts advocate that women with significant subclinical atherosclerosis should be treated with secondary prevention goals although definitive randomized trial evidence is not available.
Conclusion
A review of the data suggests that as in men women with suspected and known CAD can be accurately diagnosed and risk-stratified via contemporary cardiac imaging techniques. Despite this an abundance of evidence still suggests that women at risk for CAD are less often referred for the appropriate diagnostic test than are men. The present approaches to diagnostic testing may require some variation when applied to women and ongoing investigation is needed to fully appreciate the multifactorial role of reproductive hormones on the vascular system and diagnostic testing. Additional work also is needed to fully assimilate sex-specific issues into clinical guidelines and everyday clinical practice when appropriate. The data reviewed here however suggest that women benefit from risk stratification with commonly used noninvasive cardiac tests. Local expertise and availability should guide the selection of cardiac imaging techniques in women with suspected and known CAD who are candidates for cardiovascular screening.
Clinical Algorithm(s)
An algorithm is provided in the original guideline document for the evaluation of symptomatic women using exercise electrocardiography (ECG) or cardiac imaging.
Type of Evidence supporting the Recommendations
The type of evidence supporting the recommendations is not specifically stated.
Much of the evidence supporting contemporary recommendations for noninvasive diagnostic studies in women is extrapolated from studies conducted predominantly in cohorts of middle-aged men.
Potential Benefits
- Timely and accurate diagnosis can significantly reduce coronary artery disease (CAD) mortality for women; indeed once the diagnosis is made it does appear that current treatments are equally effective at reducing risk in both women and men.
- The diagnosis of coronary artery disease (CAD) and assessment of potential risk of cardiovascular disease are crucial steps toward improving outcomes. Thus noninvasive diagnostic and prognostic testing offers the potential to identify women at increased coronary artery disease risk and establish the basis for instituting preventive and therapeutic interventions.
Potential Harms
Not stated
Qualifying Statements
Beyond a single study no other study has included sufficient numbers of women to make confident statements about the incremental value of coronary artery calcium (CAC) testing.
Description of Implementation Strategy
An implementation strategy was not provided.
Implementation Tools
Clinical Algorithm
For information about availability see the "Availability of Companion Documents" and "Patient Resources" fields below.
IOM Care Need
Living with Illness
IOM Domain
Effectiveness
Bibliographic Source(s)
- Mieres JH Shaw LJ Arai A Budoff MJ Flamm SD Hundley WG Marwick TH Mosca L Patel AR Quinones MA Redberg RF Taubert KA Taylor AJ Thomas GS Wenger NK. Role of noninvasive testing in the clinical evaluation of women with suspected coronary artery disease: consensus statement from the Cardiac Imaging Committee Council on Clinical Cardiology and the Cardiovascular Imaging and Intervention [trunc]. Circulation 2005 Feb 8;111(5):682-96. [168 references] PubMed
Adaptation
Not applicable: The guideline was not adapted from another source.
Source(s) of Funding
American Heart Association
Guideline Committee
Cardiac Imaging Committee
Council on Clinical Cardiology
Cardiovascular Imaging and Intervention Committee
Council on Cardiovascular Radiology and Intervention
Composition of Group that Authored the Guideline
Primary Authors: Jennifer H. Mieres MD (Chair); Leslee J. Shaw PhD; Andrew Arai MD; Matthew J. Budoff MD; Scott D. Flamm MD; W. Gregory Hundley MD; Thomas H. Marwick MD PhD; Lori Mosca MD PhD; Ayan R. Patel MD; Miguel A. Quinones MD; Rita F. Redberg MD MSc; Kathryn A. Taubert PhD; Allen J. Taylor MD; Gregory S. Thomas MD MPH; Nanette K. Wenger MD
Financial Disclosures/Conflicts of Interest
The American Heart Association (AHA) makes every effort to avoid any actual or potential conflicts of interest that may arise as a result of an outside relationship or a personal professional or business interest of a member of the writing panel. Specifically all members of the writing group are required to complete and submit a Disclosure Questionnaire showing all such relationships that might be perceived as real or potential conflicts of interest.
Writing Group Disclosures
| Writing Group Member | Employment | Research Grant | Other Research Support | Speakers Bureau/Honoraria | Ownership Interest | Consultant/Advisory Board | Other |
|---|---|---|---|---|---|---|---|
| Jennifer H. Mieres | North Shore University/ Long Island Jewish Health System | Amersham Health | None | Amersham Health; Bristol-Myers Squibb Medical Imaging; Fujisawa Healthcare | None | None | None |
| Leslee J. Shaw | Cedars-Sinai Medical Center | Bristol-Myers Squibb Medical Imaging; Amersham Health; Fujisawa Healthcare | NIH/NHLBI; Department of Veterans Affairs | Bristol-Myers Squibb Medical Imaging; Amersham Health | None | CV Therapeutics; Fujisawa Healthcare | None |
| Andrew Arai | National Institutes of Health | None | None | None | None | None | None |
| Matthew J. Budoff | Harbor-University of California - Los Angeles Medical Center | None | None | None | None | None | None |
| Scott D. Flamm | Singleton Associates PA | None | None | None | None | None | None |
| W. Gregory Hundley | Wake Forest University Health Sciences | National Institutes of Health; National Heart Lung and Blood Institute; National Institute on Aging; North Carolina Strategic Technology Applied Research | None | None | None | None | None |
| Thomas H. Marwick | University of Queensland | National Heart Foundation of Australia | None | None | None | None | None |
| Lori Mosca | Columbia University | None | None | None | None | None | None |
| Ayan R. Patel | Tufts: New England Medical Center/Pratt Medical Group | None | None | None | None | None | None |
| Miguel A. Quinones | Baylor College of Medicine | None | None | None | None | None | None |
| Rita F. Redberg | University of California - San Francisco Medical Center | None | None | None | None | None | None |
| Kathryn A. Taubert | American Heart Association | None | None | None | None | None | None |
| Allen J. Taylor | US Department of Defense US Army Medical Corps | Kos; Department of Defense CDMRP | None | Kos Pharmaceuticals; Pfizer; Wyeth Laboratories | None | None | None |
| Gregory S. Thomas | Mission Internal Medical Group | CV Therapeutics | Merck | Fujisawa Healthcare; Bristol-Myers Squibb Medical Imaging; Merck; Astra-Zeneca; Kos | None | None | None |
| Nanette K. Wenger | Emory University School of Medicine | Eli Lily; Astra-Zeneca; Pfizer | None | None | Pfizer Novartis Merck Bristol-Myers Squibb Eli Lily | Eli Lily Raloxifene Advisory Committee; Heart Disease in Women Med-ED Pfizer: Cardiology/Lipidology Advisory Board Merck; Cardiology Consultant Bristol-Meyers Squibb; Ranolazine Advisory Board CV Therapeutics; Sanofi-Adventis Kos Pharmaceuticals | None |
This table represents the relationships of writing group members that may be perceived as actual or reasonably perceived conflicts of interest as reported on Disclosure Questionnaire which all members of the writing group are required to complete and submit.
Reviewer Disclosures
| Reviewer | Employment | Research Grant | Other Research Support | Speakers Bureau/Honoraria | Ownership Interest | Consultant/Advisory Board | Other |
|---|---|---|---|---|---|---|---|
| Noel C. Bairey-Merz MD | Cedars Sinai Medical Center | Merck | None | Pfizer; Merck; Kos Pharmaceuticals | Boston Scientific; IVAX; Eli Lily; Medtronic; Johnson & Johnson; SCIPIE Insurance; ATS Medical; Biosite | Pfizer; Bayer; Fujisawa Healthcare; Merck | None |
| Robert O. Bonow MD | Northwestern University | None | None | None | None | Bristol-Myers Squibb Medical Imaging; King Pharmaceuticals | None |
| Raymond J. Gibbons MD | Mayo Clinic | Medtronic; King Pharmaceuticals; Wyeth-Ayerst; Radiant Medical; INNERCOOL Therapies; Boston Scientific; Boehringer Ingelheim; Spectranetics; KAI Pharmaceuticals; TargeGen | None | None | None | CV Therapeutics; King Pharmaceuticals; Medicure; Hawaii Biotech; Molecular Insight Pharmaceuticals; Cardiovascular Clinical Studies; Ther Ox (pending); Consumers Union | None |
| Linda Gillam MD | Hartford Hospital | None | None | None | None | None | None |
| James Udelson MD | Tufts University School of Medicine | National Heart Lung and Blood Institute; King Pharmaceuticals | Molecular Insight Pharmaceuticals | Bristol-Myers Squibb Medical Imaging | None | Bristol-Myers Squibb; King Pharmaceuticals; MIP; General Electric/Amerisham | None |
| Pamela Woodard MD | Washington University School of Medicine | Mallinckrodt/Tyco | GE Healthcare; Fujisawa Healthcare | GE Healthcare | None | Berlex | None |
This table represents the relationships of reviewers that may be perceived as actual or reasonably perceived conflicts of interest as reported on Disclosure Questionnaire which all reviewers of the statement are required to complete and submit.
Guideline Status
This is the current release of the guideline.
Guideline Availability
Electronic copies: Available from the American Heart Association Web site.
Print copies: Available from the American Heart Association Public Information 7272 Greenville Ave Dallas TX 75231-4596; Phone: 800-242-8721
Availability of Companion Documents
None available
Patient Resources
None available
NGC STATUS
This summary was completed by ECRI on May 17 2005. The information was verified by the guideline developer on June 15 2005.
COPYRIGHT STATEMENT
Copyright to the original guideline is owned by the American Heart Association Inc. (AHA). Reproduction of the AHA Guideline without permission is prohibited. Single reprint is available by calling 800-242-8721 (US only) or writing the American Heart Association Public Information 7272 Greenville Ave. Dallas TX 75231-4596. Ask for reprint No. 71-0276. To purchase additional reprints: up to 999 copies call 800-611-6083 (US only) or fax 413-665-2671; 1000 or more copies call 410-528-4121 fax 410-528-4264 or email kgray@lww.com. To make photocopies for personal or educational use call the Copyright Clearance Center 978-750-8400.
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