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Safety of coronary CT angiography and functional testing for stable chest pain in the PROMISE trial: A randomized comparison of test complications, incidental findings, and radiation dose.

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Date
2017-08-15
Authors
Lu, Michael T
Douglas, Pamela S
Udelson, James E
Adami, Elizabeth
Ghoshhajra, Brian B
Picard, Michael H
Roberts, Rhonda
Lee, Kerry L
Einstein, Andrew J
Mark, Daniel B
Velazquez, Eric J
Carter, William
Ridner, Michael
Al-Khalidi, Hussein R
Hoffmann, Udo
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Abstract
BACKGROUND: Coronary computed tomography angiography (CTA) and functional testing strategies for stable chest pain yield similar outcomes; one aspect that may guide test choice is safety. METHODS: We compared test safety (test complications, incidental findings, and effective radiation dose) between CTA and functional testing as-tested in PROMISE (PROspective Multicenter Imaging Study for Evaluation of Chest Pain). In the subgroup whose physicians intended nuclear stress over other functional tests if randomized to the functional arm, we compared radiation dose of CTA versus nuclear stress and identified characteristics associated with dose. RESULTS: Of 9470 patients, none had major and <1% had minor complications (CTA: 0.8% [37/4633] vs. functional: 0.6% [27/4837]). CTA identified more incidental findings (11.6% [539/4633] vs. 0.7% [34/4837], p < 0.001), most commonly pulmonary nodules (9.4%, 437/4633). CTA had similar 90-day cumulative radiation dose to functional testing. However, in the subgroup whose physicians intended nuclear stress (CTA 3147; nuclear 3203), CTA had lower median index test (8.8 vs. 12.6 mSv, p < 0.001) and 90-day cumulative (11.6 vs. 13.1 mSv, p < 0.001) dose, independent of patient characteristics. The lowest nuclear doses employed 1-day Tc-99m protocols (12.2 mSv). The lowest CTA doses were at sites performing ≥500 CTAs/year (6.9 mSv) and with advanced (latest available) CT scanners (5.5 mSv). CONCLUSION: Complications were negligibly rare for both CTA and functional testing. CTA detects more incidental findings. Compared to nuclear stress testing, CTA's lower radiation dose, independent of patient characteristics, makes it an attractive test choice. Radiation dose varies with imaging protocol, indicating opportunities to further reduce dose. (ClinicalTrials.gov number, NCT01174550).
Type
Journal article
Subject
Chest pain
Coronary artery disease
Coronary computed tomography angiography
Functional testing
Permalink
https://hdl.handle.net/10161/15409
Published Version (Please cite this version)
10.1016/j.jcct.2017.08.005
Publication Info
Lu, Michael T; Douglas, Pamela S; Udelson, James E; Adami, Elizabeth; Ghoshhajra, Brian B; Picard, Michael H; ... Hoffmann, Udo (2017). Safety of coronary CT angiography and functional testing for stable chest pain in the PROMISE trial: A randomized comparison of test complications, incidental findings, and radiation dose. J Cardiovasc Comput Tomogr. 10.1016/j.jcct.2017.08.005. Retrieved from https://hdl.handle.net/10161/15409.
This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.
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Scholars@Duke

Al-Khalidi

Hussein Rashid Al-Khalidi

Professor of Biostatistics & Bioinformatics
My research interest includes design and analysis of cardiovascular clinical trials, medical devices, survival analysis, group-sequential analysis, time-to-recurrent or multiple events, continuous-time Markov models, stochastic process, linear model, dose-response modeling, design of experiments and adaptive designs.
Douglas

Pamela Susan Douglas

Ursula Geller Distinguished Professor for Research in Cardiovascular Disease, in the School of Medicine
Pamela S Douglas MD is the Ursula Geller Professor of Research in Cardiovascular Diseases in the Department of Medicine at Duke University and Director of the Multimodality Imaging Program at Duke Clinical Research Institute. During her 30+ years of experience she has led several landmark multicenter government studies and pivotal industry clinical trials along with outcomes research studies.  She is renowned for her scientific and policy work in improving the quality and appropriateness
Lee

Kerry L. Lee

Professor Emeritus of Biostatistics & Bioinformatics
As a faculty-level biostatistician, my research activities are focused on the statistical and data coordination aspects of several large multicenter clinical trials, and on statistical issues in the design and analysis of collaborative clinical research projects associated with the Duke University Cardiovascular Disease Database. I am currently the principal investigator of the statistical and data coordinating center for two NIH-sponsored multicenter randomized clinical trials, namely (1
Mark

Daniel Benjamin Mark

Professor of Medicine
Dr. Mark is a clinical cardiologist with the rank of Professor of Medicine (with tenure) as well as Vice Chief for Academic Affairs in the Division of Cardiology, Department of Medicine at Duke University Medical Center. He is also the Director of Outcomes Research at the Duke Clinical Research Institute. He has been on the full-time faculty at Duke since 1985. Prior to that he completed his cardiology fellowship at Duke, his residency and internship at the University of Virginia Hospita
Velazquez

Eric J. Velazquez

Adjunct Professor in the Department of Medicine
LeadershipEric J. Velazquez, MD, is a Professor of Medicine with tenure at Duke University.  As section chief for Cardiovascular Imaging in the Division of Cardiology and director of the Cardiac Diagnostic Unit and Echocardiography Laboratories for Duke University Health System, he coordinates a high-volume enterprise and an outstanding group of clinician-investigators and clinical staff who make important contributions across patient care, research and educational
This author no longer has a Scholars@Duke profile, so the information shown here reflects their Duke status at the time this item was deposited.
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