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Quality-of-Life Outcomes With Anatomic Versus Functional Diagnostic Testing Strategies in Symptomatic Patients With Suspected Coronary Artery Disease: Results From the PROMISE Randomized Trial.

Publication ,  Journal Article
Mark, DB; Anstrom, KJ; Sheng, S; Baloch, KN; Daniels, MR; Hoffmann, U; Patel, MR; Cooper, LS; Lee, KL; Douglas, PS; PROMISE Investigators,
Published in: Circulation
May 24, 2016

BACKGROUND: The Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) trial found that initial use of ≥64 detector-row computed tomography angiography versus standard functional testing strategies (exercise ECG, stress nuclear methods, or stress echocardiography) did not improve clinical outcomes in 10 003 stable symptomatic patients with suspected coronary artery disease requiring noninvasive testing. Symptom burden and quality of life (QOL) were major secondary outcomes. METHODS AND RESULTS: We prospectively collected a battery of QOL instruments in 5985 patients at baseline and 6, 12, and 24 months postrandomization. The prespecified primary QOL measures were the Duke Activity Status Index and the Seattle Angina Questionnaire frequency and QOL scales. All comparisons were made as randomized. Baseline variables were well balanced in the 2982 patients randomly assigned to computed tomography angiography testing and the 3003 patients randomly assigned to functional testing. The Duke Activity Status Index improved substantially in both groups over the first 6 months following testing, but we found no evidence for a strategy-related difference (mean difference [anatomic - functional] at 24 months of follow-up, 0.1 [95% confidence interval, -0.9 to 1.1]). Similar results were seen for the Seattle Angina Questionnaire frequency scale (mean difference at 24 months, -0.2; 95% confidence interval, -0.8 to 0.4) and QOL scale (mean difference at 24 months, -0.2; 95% confidence interval, -1.3 to 0.9). None of the secondary QOL measures showed a consistent strategy-related difference. CONCLUSIONS: In symptomatic patients with suspected coronary artery disease who required noninvasive testing, symptoms and QOL improved significantly. However, a strategy of initial anatomic testing, in comparison with functional testing, did not provide an incremental benefit for QOL over 2 years of follow-up. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01174550.

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Published In

Circulation

DOI

EISSN

1524-4539

Publication Date

May 24, 2016

Volume

133

Issue

21

Start / End Page

1995 / 2007

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Tomography Scanners, X-Ray Computed
  • Quality of Life
  • Prospective Studies
  • Middle Aged
  • Male
  • Humans
  • Follow-Up Studies
  • Female
  • Electrocardiography
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Mark, D. B., Anstrom, K. J., Sheng, S., Baloch, K. N., Daniels, M. R., Hoffmann, U., … PROMISE Investigators, . (2016). Quality-of-Life Outcomes With Anatomic Versus Functional Diagnostic Testing Strategies in Symptomatic Patients With Suspected Coronary Artery Disease: Results From the PROMISE Randomized Trial. Circulation, 133(21), 1995–2007. https://doi.org/10.1161/CIRCULATIONAHA.115.020259
Mark, Daniel B., Kevin J. Anstrom, Shubin Sheng, Khaula N. Baloch, Melanie R. Daniels, Udo Hoffmann, Manesh R. Patel, et al. “Quality-of-Life Outcomes With Anatomic Versus Functional Diagnostic Testing Strategies in Symptomatic Patients With Suspected Coronary Artery Disease: Results From the PROMISE Randomized Trial.Circulation 133, no. 21 (May 24, 2016): 1995–2007. https://doi.org/10.1161/CIRCULATIONAHA.115.020259.
Mark, Daniel B., et al. “Quality-of-Life Outcomes With Anatomic Versus Functional Diagnostic Testing Strategies in Symptomatic Patients With Suspected Coronary Artery Disease: Results From the PROMISE Randomized Trial.Circulation, vol. 133, no. 21, May 2016, pp. 1995–2007. Pubmed, doi:10.1161/CIRCULATIONAHA.115.020259.
Mark DB, Anstrom KJ, Sheng S, Baloch KN, Daniels MR, Hoffmann U, Patel MR, Cooper LS, Lee KL, Douglas PS, PROMISE Investigators. Quality-of-Life Outcomes With Anatomic Versus Functional Diagnostic Testing Strategies in Symptomatic Patients With Suspected Coronary Artery Disease: Results From the PROMISE Randomized Trial. Circulation. 2016 May 24;133(21):1995–2007.

Published In

Circulation

DOI

EISSN

1524-4539

Publication Date

May 24, 2016

Volume

133

Issue

21

Start / End Page

1995 / 2007

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Tomography Scanners, X-Ray Computed
  • Quality of Life
  • Prospective Studies
  • Middle Aged
  • Male
  • Humans
  • Follow-Up Studies
  • Female
  • Electrocardiography