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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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).
Published Version (Please cite this version)10.1016/j.jcct.2017.08.005
Publication InfoAdami, E; Al-Khalidi, Hussein; Carter, W; Douglas, Pamela Susan; Einstein, AJ; Ghoshhajra, BB; ... Velazquez, Eric J (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 http://hdl.handle.net/10161/15409.
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Associate Professor of Biostatistics and 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.
Ursula Geller 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
Assistant Professor of Anesthesiology
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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