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.
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).
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Journal articlePermalink
https://hdl.handle.net/10161/15409Published Version (Please cite this version)
10.1016/j.jcct.2017.08.005Publication 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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Show full item recordScholars@Duke
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.
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
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
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
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
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