Coronary CT Angiography versus Standard Evaluation in Acute Chest Pain
Reporter: Aviva Lev-Ari, PhD, RN
Coronary CT Angiography versus Standard Evaluation in Acute Chest Pain
Udo Hoffmann, M.D., M.P.H., Quynh A. Truong, M.D., M.P.H., David A. Schoenfeld, Ph.D., Eric T. Chou, M.D., Pamela K. Woodard, M.D., John T. Nagurney, M.D., M.P.H., J. Hector Pope, M.D., Thomas H. Hauser, M.D., M.P.H., Charles S. White, M.D., Scott G. Weiner, M.D., M.P.H., Shant Kalanjian, M.D., Michael E. Mullins, M.D., Issam Mikati, M.D., W. Frank Peacock, M.D., Pearl Zakroysky, B.A., Douglas Hayden, Ph.D., Alexander Goehler, M.D., Ph.D., Hang Lee, Ph.D., G. Scott Gazelle, M.D., M.P.H., Ph.D., Stephen D. Wiviott, M.D., Jerome L. Fleg, M.D., and James E. Udelson, M.D. for the ROMICAT-II Investigators
BACKGROUND
It is unclear whether an evaluation incorporating coronary computed tomographic angiography (CCTA) is more effective than standard evaluation in the emergency department in patients with symptoms suggestive of acute coronary syndromes.
METHODS
In this multicenter trial, we randomly assigned patients 40 to 74 years of age with symptoms suggestive of acute coronary syndromes but without ischemic electrocardiographic changes or an initial positive troponin test to early CCTA or to standard evaluation in the emergency department on weekdays during daylight hours between April 2010 and January 2012. The primary end point was length of stay in the hospital. Secondary end points included rates of discharge from the emergency department, major adverse cardiovascular events at 28 days, and cumulative costs. Safety end points were undetected acute coronary syndromes.
RESULTS
The rate of acute coronary syndromes among 1000 patients with a mean (±SD) age of 54±8 years (47% women) was 8%. After early CCTA, as compared with standard evaluation, the mean length of stay in the hospital was reduced by 7.6 hours (P<0.001) and more patients were discharged directly from the emergency department (47% vs. 12%, P<0.001). There were no undetected acute coronary syndromes and no significant differences in major adverse cardiovascular events at 28 days. After CCTA, there was more downstream testing and higher radiation exposure. The cumulative mean cost of care was similar in the CCTA group and the standard-evaluation group ($4,289 and $4,060, respectively; P=0.65).
CONCLUSIONS
In patients in the emergency department with symptoms suggestive of acute coronary syndromes, incorporating CCTA into a triage strategy improved the efficiency of clinical decision making, as compared with a standard evaluation in the emergency department, but it resulted in an increase in downstream testing and radiation exposure with no decrease in the overall costs of care. (Funded by the National Heart, Lung, and Blood Institute; ROMICAT-II ClinicalTrials.gov number, NCT01084239.)
Supported by grants from the National Heart, Lung, and Blood Institute (U01HL092040 and U01HL092022) and the National Institutes of Health (UL1RR025758, K23HL098370, and L30HL093896, to Dr. Truong).
Dr. Gazelle reports receiving consulting fees from GE Healthcare; Dr. Hauser, receiving consulting fees from Astellas and the Harvard Clinical Research Institute; Dr. Hoffmann, receiving grant support from the American College of Radiology Imaging Network, Bracco Diagnostics, Genentech, and Siemens Healthcare on behalf of his institution; Dr. Nagurney, receiving grant support from Alere (Biosite), Brahms Diagnostica (Fischer), and Nanosphere on behalf of his institution; Dr. Truong, receiving grant support from St. Jude Medical and Qi Imaging on behalf of her institution and travel support from Medconvent and the Society of Cardiac Computed Tomography; Dr. Wiviott, receiving consulting fees from Arena Pharmaceuticals, AstraZeneca, Bayer, Bristol-Myers Squibb, and Ortho-McNeil, grant support from AstraZeneca, Daiichi Sankyo, Eli Lilly, and Merck and Schering-Plough on behalf of his institution, and lecture fees from AstraZeneca, Daiichi Sankyo, Eli Lilly, Novartis, and Schering-Plough; and Dr. Udelson, being on the scientific advisory board of Lantheus Medical Imaging. No other potential conflict of interest relevant to this article was reported.
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
SOURCE INFORMATION
The authors’ affiliations are listed in the Appendix.
Address reprint requests to Dr. Hoffmann at Massachusetts General Hospital, Cardiac MR PET CT Program, 165 Cambridge St., Suite 400, Boston, MA 02114, or at uhoffmann@partners.org.
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symptoms suggestive of acute coronary syndromes but without ischemic electrocardiographic changes or an initial positive troponin test to early CCTA or to standard evaluation in the emergency department
period is between 2010 and 2012
This is interesting and raises questions about the design of the study and the results:
1) two companies stand out with respect to diagnostics – Alere (Biosite), Brahms Diagnostica (Fischer) – Alere bought Biosite POC analyzer with CKMB, troponin, myoglobin. Fisher bought Brahms, which had no cardiac biomarker on the market that I know of.
2) Only the first troponin assay was run, but the standard of a second assay 3-4 hours apart was under discussion. A rise in troponin would be expected, and the slope of the rise has only recently evaluated.
3) There is no mention of a hs troponin assay, which gives a huge increase in the false positive rate. It was about 2010 that Ortho installed the hs TnI, which would pick up CHF and arrhythmias not seen as frequently with the old assay.
The approved cutoff for the test is the lowest value measureable at 10% CV. Above that value is high (but MI is called at a higher value).
It appears that the study is a wash in this low probability population. I hope that some of the downstream testing did not include catheterization. The risk of inducing an MI would be higher in this population than rescheduling on an outpatient basis.
While the risk of inducing an MI would be higher in this population than rescheduling on an outpatient basis, I worked on a cardiac floor at MGH and we received via Helicopters on the roof of MGH, patients with MI form the Cottage Hospital on Nantucket, MA from the Golf Course, via helicopter to the roof of MGH. No one ever considered risk of induction of MI when the symptoms were of syncope.
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