What Is the Optimal Method for Ischemia Evaluation in Women - WOMEN

Aug 25, 2011
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
GE Healthcare
Date Published:
01/01/2011
Date Updated:
08/25/2011
Original Posted Date:
08/25/2011
References

Description:

The goal of this trial was to evaluate exercise treadmill testing (ETT) alone compared with exercise-myocardial perfusion imaging (MPI) among symptomatic women with suspected coronary artery disease.

Hypothesis:

ETT will result in similar long-term outcomes.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Women with typical/atypical angina or angina equivalent (dyspnea)
  • Interpretable ECG
  • Age ≥40 years
  • Capable of performing ≥5 METs on the DASI questionnaire
  • Intermediate pretest likelihood for coronary artery disease
  • Intermediate pretest likelihood defined as age ≥50 years with typical/atypical angina, age ≥60 years with nonangina symptoms

    Number of screened applicants: 2,859
    Number of enrollees: 824
    Duration of follow-up: 2 years
    Mean patient age: median 63 years
    Percentage female: 100%

Primary Endpoints:

  • Cardiac death, nonfatal myocardial infarction, or hospitalization for an acute coronary syndrome or heart failure

Secondary Endpoints:

  • Hospitalization for any chest pain
  • Quality of life
  • All-cause mortality

Drug/Procedures Used:

Symptomatic women with suspected coronary artery disease were randomized to ETT alone (n = 412) compared with exercise-MPI (n = 412).

Concomitant Medications:

At baseline, the use of aspirin was 33%, statin was 32%, beta-blocker was 18%, and angiotensin-converting enzyme inhibitor was 16%.

Principal Findings:

Overall, 824 women were randomized. The median age was 63 years, 78% were postmenopausal, mean blood pressure was 130/80 mm Hg, mean body mass index was 27 kg/m2, 13% had diabetes, 89% had chest pain, and 54% had dyspnea.

Women exercised to a mean of 8.4 METs (lower than predicted from the Duke Activity Status Index [DASI]). Among women randomized to ETT, the test was normal in 64%, indeterminate in 16%, and abnormal in 20%. Crossover to MPI occurred in 8%, 25%, and 43%, respectively, for normal, indeterminate, and abnormal electrocardiogram (ECG) results (p < 0.0001). Referral to angiography occurred in 3%, 7%, and 18% (p < 0.0001), respectively.

Among women randomized to exercise-MPI, imaging was normal in 91%, mildly abnormal in 3%, and moderately to severely abnormal in 6%. Repeat MPI occurred in 9%, 8%, and 15%, respectively, for normal, mildly abnormal, and moderate to severely abnormal results (p = 0.52). Referral to angiography occurred in 4%, 0%, and 29% (p < 0.0001), respectively.

At 2 years, freedom from the primary outcome was 98% among the ETT group versus 98% among the exercise-MPI group (p = 0.59).

Overall diagnostic costs were 48% lower for ETT compared with exercise-MPI (p < 0.0001).

Interpretation:

Among symptomatic women with suspected coronary artery disease, evaluation with ETT is safe and effective. The addition of MPI did not significantly improve 2-year outcomes. As expected, there was a relatively high crossover to MPI when ETT was indeterminate or abnormal; however, the test was normal in two-thirds of women. Referral to angiography in the ETT group was relatively low unless the test was abnormal. Overall diagnostic costs were approximately one half in the ETT group compared with the exercise-MPI group.

The diagnostic accuracy of ETT in women has been questioned; however, this study affirms this modality remains a front-line test for symptomatic women with an interpretable ECG who are able to exercise.

References:

Shaw LJ, Mieres JH, Hendel RH, et al., on behalf of the WOMEN trial investigators. Comparative effectiveness of exercise electrocardiography with or without myocardial perfusion single photon emission computed tomography in women with suspected coronary artery disease. Results from the What Is the Optimal Method for Ischemia Evaluation in Women (WOMEN) trial. Circulation 2011;Aug 15:[Epub ahead of print].

Keywords: Myocardial Perfusion Imaging, Coronary Artery Disease, Follow-Up Studies, Referral and Consultation, Blood Pressure, Electrocardiography, Dyspnea, Body Mass Index, Chest Pain, Surveys and Questionnaires, Diabetes Mellitus, Exercise Test


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