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Posts Tagged ‘Computed tomography angiography’


Reporter: Aviva Lev-Ari, PhD, RN

CT Scanner Delivers Less Radiation

Faster, more sensitive scans and better image processing may reduce the risk of x-ray-related cancers.

 WHY IT MATTERS

A new CT scanner exposes patients to less radiation while providing doctors with clearer images to help with diagnoses, according to researchers at the National Institutes of Health.

“CT” stands for Computerized Tomography, which involves combining lots of x-ray images taken from different angles into a three-dimensional view of what’s inside the body. The technology can be especially useful for diagnoses in emergency situations, and the number of CT scans in recent years has increased dramatically, says Marcus Chen, a cardiovascular imager at the National Heart, Lung and Blood Institute, in Bethesda, Maryland.  But the increase in the use of CT scans raises concerns about the amount of radiation to which patients are exposed, says Chen.

The risk of developing cancer from the radiation delivered by one CT scan is low, but the large number of scans performed each year—more than 70 million—translates to a significant risk. Researchers at the National Cancer Institute estimated that the 72 million CT scans performed in the U.S. in 2007 could lead to 29,000 new cancers. On average, the organ studied in a CT scan of an adult receives around 15 millisieverts of radiation, compared with roughly 3.1 millisieverts of radiation exposurefrom natural sources each year.

This concern has led researchers to seek ways to reduce the amount of radiation exposure a patient receives in a scan. They are working to improve both hardware, to make the scans go faster and need less repetition, and software, to process the x-ray data better (see “Clear CT Scans with Less Radiation”).

The new CT scanning system, from Toshiba Medical, combines several improvements to reduce radiation exposure. The overall body of a CT scanner is shaped like a large ring. An x-ray tube and a detector spin separately in the ring, opposite one another, and a patient lies in the center.  X-rays travel through the patient as they are delivered by the tube and captured by the detectors. The new Toshiba machine has five times as many detectors as most machines, which means that more of an organ can be captured at a time, decreasing the number of passes of the scanner required.

The x-ray components in the new system also spin faster—it takes only 275 milliseconds for them to complete a rotation, instead of 350 millisesconds—which means a patient gets irradiated for less time. In cases where doctors are looking at a moving organ such as the heart, the faster spinning also reduces the number of times a doctor may need to try to get a good image. “It’s like having faster film in your camera,” says Chen.  Changes to the way the system generates x-rays and computes the images also mean patients spend less time getting hit with radiation.

Chen and colleagues at the National Heart Lung and Blood Institute used the Toshiba system to examine 107 adult patients of different ages and sizes for plaque buildup and cardiovascular problems. Patient size matters because more x-rays are required to image a larger person. “A lot of imaging centers will use one setting for all patients,” says Chen. “You get beautiful image quality on everybody, but the downside is that some patients get more radiation than they probably should.” In his study, the system takes a quick preliminary scan that uses low-dose x-rays to figure out how big a patient is and how much radiation will be needed for the diagnostic image.

Most patients who got a scan in the new Toshiba machine received 0.93 millisieverts of radiation, and almost every patient received less than 4 millisieverts. Radiation exposure was decreased by as much as 95 percent relative to other CT scanners currently in use.

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The reader is advised to review Alternative #3 in the following article, published on 3/10/2013, including the Editorial in NEJM by Dr. Redberg, UCSF, included in the article, prior to reading the content, below — as background on this important topic having the potential to change best practice and standard of care in the ER/ED.

Acute Chest Pain/ER Admission: Three Emerging Alternatives to Angiography and PCI – Corus CAD, hs cTn, CCTA

CCTA for Chest Pain Cuts Costs, Admissions

By Eric Barnes, AuntMinnie.com staff writer

May 14, 2013 — One of the largest studies yet comparing medical resource use and outcomes among chest pain patients found that coronary CT angiography (CCTA) reduced medical resource utilization compared to standard care, generating fewer hospital admissions and shorter emergency room stays, researchers reported in the Journal of the American College of Cardiology.

The retrospective study compared matched cohorts of nearly 1,000 patients presenting with chest pain before and after implementation of routine CCTA evaluation. The study team from Stony Brook, NY, and two other institutions found that patients receiving the standard workup for chest pain — which is to say, mostly observation — were admitted to the hospital almost five times as frequently as patients receiving CT. The standard workup patients also had significantly longer stays when admitted.

The rates of invasive angiography without revascularization and recidivism were also much higher for patients receiving standard care (JACC, May 14, 2013).

“I think the take-home message is that CT done correctly by experts with the resources to do it correctly on a routine basis is not only safe and feasible, but reduces healthcare resource utilization,” said lead author Dr. Michael Poon, from Stony Brook Medical Center, in an interview with AuntMinnie.com.

More than $10 billion in costs

Caring for chest pain is an expensive proposition in the U.S., costing upward of $10 billion a year for some 6 million emergency department (ED) visits. To reduce the problem of overcrowded emergency rooms, some hospitals have implemented chest pain evaluation units, but the care isn’t comprehensive or necessarily all that helpful, Poon said.

“It has been a problem and a major dilemma for emergency rooms because for most patients, it’s a false alarm,” he said. “I would say nine out of 10 are false alarms, but how to pick out that one is very tricky and costly. So what most hospitals tend to do is a one-size-fits-all policy where everybody gets blood tests and an electrocardiogram, and they keep patients in the ED for an extended period of time. So if you come in Friday, you may stay until Monday.”

Coronary CTA has been shown to be safe and cost-effective for acute chest pain evaluation in several smaller studies and in three smaller multicenter trials, but those studies have been limited by a lack of CT availability outside of weekdays and office hours, while EDs must operate 24/7, Poon said.

“All of those studies were done in a randomized, controlled fashion and in an artificial environment,” where each patient was randomized to either a stress test or CT during weekday office hours, Poon said. “But in real life, there is no such thing; it cannot be done.”

More often, chest pain patients get a couple of tests and several hours of observation before they are sent home.

Poon and colleagues from Stony Brook, William Beaumont Hospital, and the University of Toronto wanted to do a “real-world” observational study to show that CT remained cost-effective and efficient for triaging chest pain patients.

The study sought to compare the overall impact of CT on clinical outcomes and efficacy, when comparing CCTA and the hospital’s standard evaluation for the triage of chest pain patients, with CCTA available 12 hours a day, seven days a week.

From a total of 9,308 patients with a chest pain diagnosis upon admission, the study used a matched sample of 894 patients without a history of coronary artery disease and without positive troponin or ischemic changes on an electrocardiogram.

Patients undergoing CT were scanned on a 64-detector-row scanner (LightSpeed VCT, GE Healthcare) following administration of iodinated contrast and metoprolol as a beta-blocker for those with heart rates faster than 65 beats per minute (bpm).

Those with a body mass index (BMI) less than 30 were scanned at 100 kV, while those with a BMI between 30 and 50 were scanned at 120 kV. Retrospective gating was reserved for patients whose heart rates remained above 65 bpm. Obstructive stenosis was defined as 50% or greater lumen narrowing.

CT choice faster, more efficient

The results showed a lower overall admission rate of 14% for CCTA, compared with 40% for the standard of care (p < 0.001). In fact, patients undergoing standard evaluation were 5.5 times more likely to be admitted (p < 0.001) than CCTA patients.

The length of stay in the ED was 1.6 times longer for standard care (p < 0.001) than for CCTA. For patients undergoing CCTA, the median radiation dose was 5.88 mSv.

“We also showed that the recidivism rate is higher for standard of care, meaning that they come back within one month with recurrent chest pain,” Poon said. The odds of returning to the ED within 30 days were five times greater for patients in the standard evaluation group (odds ratio, 5.06; p = 0.022).

“In the era of Obamacare, this is a penalty to the hospital; you don’t want the patient returning within one month with the same diagnosis,” he said. When that happens, “you’re not only not getting paid, you have to pay a penalty. It’s a double whammy. We also show that downstream invasive coronary angiography is significantly less in the CCTA arm.”

More invasive angiography

Patients receiving standard care were seven times more likely to undergo invasive coronary angiography without revascularization (odds ratio, 7.17; p ≤ 0.001), while neither patient group was significantly more likely to undergo revascularization.

“Many physicians use [catheterization] as a way of getting patients in and out of the hospital,” Poon said. However, the cost is more than $10,000 per procedure.

The high rate of angiography without revascularization in the standard care group was not seen in the Rule Out Myocardial Infarction/Ischemia Using Computer Assisted Tomography (ROMICAT) I and II trials, where all patients in the standard care group underwent stress testing before angiography was considered, he said.

Poon credited the ROMICAT trials’ routine use of stress tests with diminishing CT’s relative advantage in resource use. “In the real world, that is not available,” he said. The present study, in which only about 20% of the standard care patients underwent stress tests, is more realistic.

Finally, Poon and colleagues showed no difference in rates of myocardial infarction between CT and the standard of care within the first 30 days of follow up. However, that is changing as patients are followed for longer time periods, he noted.

“We see a trend starting to diverge in our next report, which follows [patients] for six months,” he said. “You see a lot more acute myocardial infarction in the standard care arm, and we’re going to extend it for a year.”

The authors concluded that using CCTA to rule out acute coronary syndromes in low-risk chest pain patients is likely to improve doctors’ ability to triage patients with the common presentation of chest pain. The result of this approach appears to be fewer hospital admissions, shorter stays, less recidivism, less invasive angiography, and better patient outcomes.

In any case, Poon said, the study method is permanent at Stony Brook University, where the standard of care now incorporates CCTA.

“We didn’t stop doing it after the study,” he said. “If you look at some of the randomized, controlled studies, they actually went back to the standard of care.” They had to because those kinds of protocols are only practical with a grant.

Related Reading

CORE 320 study evaluates CCTA and SPECT for CAD diagnosis, March 25, 2013

Study affirms CCTA’s value to rule out myocardial infarction, March 19, 2013

CCTA predicts heart attack in people without risk factors, February 19, 2013

Study: Use CCTA 1st for lower-risk chest pain patients, February 4, 2013

2010 CCTA appropriateness criteria yield mixed results, January 31, 2013
Copyright © 2013 AuntMinnie.com

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Other related articles on this Open Access Online Scientific Journal include the following:

Economic Toll of Heart Failure in the US: Forecasting the Impact of Heart Failure in the United States – A Policy Statement From the American Heart Association

Aviva Lev-Ari, PhD, RN, 4/25/2013

https://pharmaceuticalintelligence.com/2013/04/25/economic-toll-of-heart-failure-in-the-us-forecasting-the-impact-of-heart-failure-in-the-united-states-a-policy-statement-from-the-american-heart-association/

Diagnosis of Cardiovascular Disease, Treatment and Prevention: Current & Predicted Cost of Care and the Promise of Individualized Medicine Using Clinical Decision Support Systems

Larry H Bernstein, MD, FACP and Aviva Lev-Ari, PhD, RN, Curator, 5/15/2013

https://pharmaceuticalintelligence.com/2013/05/15/diagnosis-of-cardiovascular-disease-treatment-and-prevention-current-predicted-cost-of-care-and-the-promise-of-individualized-medicine-using-clinical-decision-support-systems-2/

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Acute Chest Pain/ER Admission: Three Emerging Alternatives to Angiography and PCI – Corus CAD, hs cTn, CCTA

Curator: Aviva Lev-Ari, PhD, RN

We examine the emergence of Alternatives to Angiography and PCI as most common strategy for ER admission with listed cause of Acute Chest Pain. The Goal is to use methods that will improve the process to identify for an Interventional procedure only the patients that a PCI is a must to have.

Alternative #1: Corus®  CAD

Alternative #2: High-Sensitivity Cardiac Troponins in Acute Cardiac Care

Alternative #3: Coronary CT Angiography for Acute Chest Pain

 

After presenting the Three alternatives, the Editorial by R.F. Redberg, Division of Cardiology, UCSF, will be analyzed.
  • Alternative #1:  First-Line Test to Help Clinicians Exclude Obstructive CAD as a Cause of the Patient’s Symptoms

Corus®  CAD, a blood-based  gene expression test, demonstrated high accuracy with both a high negative predictive value (96 percent) and high sensitivity (89 percent) for assessing  obstructive coronary artery disease  (CAD) in a population of patients referred for stress testing with myocardial perfusion imaging (MPI).

COMPASS enrolled stable patients with symptoms suggestive of CAD who had been referred for MPI at 19 U.S. sites.  A blood sample was obtained in all 431 patients prior to MPI and Corus CAD gene expression testing was performed with study investigators blinded to Corus CAD test results.Following MPI, patients underwent either invasive coronary angiography orcoronary CT angiography, gold-standard anatomical tests for the diagnosis of coronary artery disease.

A Blood Based Gene Expression Test for Obstructive Coronary Artery Disease Tested in Symptomatic Non-Diabetic Patients Referred for Myocardial Perfusion Imaging: The COMPASS Study

https://pharmaceuticalintelligence.com/2012/08/14/obstructive-coronary-artery-disease-diagnosed-by-rna-levels-of-23-genes-cardiodx-heart-disease-test-wins-medicare-coverage/

  • Alternative #2: High-Sensitivity Cardiac Troponins in Acute Cardiac Care

Recommendations for the use of cardiac troponin (cTn) measurement in acute cardiac care have recently been published.[1] Subsequently, a high-sensitivity (hs) cTn T assay was introduced into routine clinical practice.[2] This assay, as others, called highly sensitive, permits measurement of cTn concentrations in significant numbers of apparently illness-free individuals. These assays can measure cTn in the single digit range of nanograms per litre (=picograms per millilitre) and some research assays even allow detection of concentrations <1 ng/L.[2–4] Thus, they provide a more precise calculation of the 99th percentile of cTn concentration in reference subjects (the recommended upper reference limit [URL]). These assays measure the URL with a coefficient of variation (CV) <10%.[2–4]The high precision of hs-cTn assays increases their ability to determine small differences in cTn over time. Many assays currently in use have a CV >10% at the 99th percentile URL limiting that ability.[5–7] However, the less precise cTn assays do not cause clinically relevant false-positive diagnosis of acute myocardial infarction (AMI) and a CV <20% at the 99th percentile URL is still considered acceptable.[8]

We believe that hs-cTn assays, if used appropriately, will improve clinical care. We propose criteria for the clinical interpretation of test results based on the limited evidence available at this time.

References

1. Thygesen K, Mair J, Katus H, Plebani M, Venge P, Collinson P, Lindahl B,

Giannitsis E, Hasin Y, Galvani M, Tubaro M, Alpert JS, Biasucci LM, Koenig W,

Mueller C, Huber K, Hamm C, Jaffe AS; Study Group on Biomarkers in Cardiology

of the ESC Working Group on Acute Cardiac Care. Recommendations

for the use of cardiac troponin measurement in acute cardiac care. Eur Heart J

2010;31:2197–2204.

2. Saenger AK, Beyrau R, Braun S, Cooray R, Dolci A, Freidank H, Giannitsis E,

Gustafson S, Handy B, Katus H, Melanson SE, Panteghini M, Venge P, Zorn M,

Jarolim P, Bruton D, Jarausch J, Jaffe AS. Multicenter analytical evaluation of a highsensitivity

troponin T assay. Clin Chim Acta 2011;412:748–754.

3. Zaninotto M, Mion MM, Novello E, Moretti M, Delprete E, Rocchi MB, Sisti D,

Plebani M. Precision performance at low levels and 99th percentile concentration

of the Access AccuTnI assay on two different platforms. Clin Chem Lab Med 2009;

47:367–371.

4. Todd J, Freese B, Lu A, Held D, Morey J, Livingston R, Goix P. Ultrasensitive flowbased

immunoassays using single-molecule counting. Clin Chem 2007;53:

1990–1995.

5. van de Kerkhof D, Peters B, Scharnhorst V. Performance of Advia Centaur

second-generation troponin assay TnI-Ultra compared with the first-generation

cTnI assay. Ann Clin Biochem 2008;45:316–317.

6. Lam Q, Black M, Youdell O, Spilsbury H, Schneider HG. Performance evaluation

and subsequent clinical experience with the Abbott automated Architect STAT

Troponin-I assay. Clin Chem 2006;52:298–300.

7. Tate JR, Ferguson W, Bais R, Kostner K, Marwick T, Carter A. The determination

of the 99th percentile level for troponin assays in an Australian reference population.

Ann Clin Biochem 2008;45:275–288.

8. Jaffe AS, Apple FS, Morrow DA, Lindahl B, Katus HA. Being rational about (im)-

precision: a statement from the Biochemistry Subcommittee of the Joint European

Society of Cardiology/American College of Cardiology Foundation/

American Heart Association/World Heart Federation Task Force for the definition of myocardial infarction. Clin Chem 2010;56:921–943.

To the Editor:

Hoffmann et al. (July 26 issue)1 conclude that, among patients with low-to-intermediate-risk acute coronary syndromes, the incorporation of coronary computed tomographic angiography (CCTA) improves the standard evaluation strategy.2 However, it may be difficult to generalize their results, owing to different situations on the two sides of the Atlantic and the availability of high-sensitivity troponin T assays in Europe. In the United States, the Food and Drug Administration has still not approved a high-sensitivity troponin test, and patients in the Rule Out Myocardial Infarction/Ischemia Using Computer Assisted Tomography (ROMICAT-II) trial only underwent testing with the conventional troponin T test. As we found in the biomarker substudy in the ROMICAT-I trial, a single high-sensitivity troponin T test at the time of CCTA accurately ruled out acute myocardial infarction (negative predictive value, 100%) (Table 1TABLE 1Results of High-Sensitivity Troponin T Testing for the Diagnosis of Acute Coronary Syndromes in ROMICAT-I.).3 In addition, patients with acute myocardial infarction can be reliably identified, with up to 100% sensitivity, with the use of two high-sensitivity measurements of troponin T within 3 hours after admission.4,5

It seems plausible to assume that the incorporation of high-sensitivity troponin T assays in this trial would have outperformed CCTA. Therefore, it is important to assess the performance of such testing and compare it with routine CCTA testing in terms of length of stay in the hospital and secondary end points, especially cumulative costs and major adverse coronary events at 28 days.

Mahir Karakas, M.D.
Wolfgang Koenig, M.D.
University of Ulm Medical Center, Ulm, Germany
wolfgang.koenig@uniklinik-ulm.de

References

  1. Hoffmann U, Truong QA, Schoenfeld DA, et al. Coronary CT angiography versus standard evaluation in acute chest pain. N Engl J Med 2012;367:299-308

  2. Redberg RF. Coronary CT angiography for acute chest pain. N Engl J Med 2012;367:375-376

  3. Januzzi JL Jr, Bamberg F, Lee H, et al. High-sensitivity troponin T concentrations in acute chest pain patients evaluated with cardiac computed tomography. Circulation2010;121:1227-1234

  4. Keller T, Zeller T, Ojeda F, et al. Serial changes in highly sensitive troponin I assay and early diagnosis of myocardial infarction. JAMA 2011;306:2684-2693

  5. Thygesen K, Mair J, Giannitsis E, et al. How to use high-sensitivity cardiac troponins in acute cardiac care. Eur Heart J 2012;33:2252-2257

Author/Editor Response

In response to Karakas and Koenig: we agree that high-sensitivity troponin T assays may permit more efficient care of low-risk patients presenting to the emergency department with acute chest pain1 and may also have the potential to identify patients with unstable angina because cardiac troponin T levels are associated with the degree and severity of coronary artery disease.2 Hence, high-sensitivity troponin T assays performed early may constitute an efficient and safe gatekeeper for imaging. CCTA, however, may be useful for ruling out coronary artery disease in patients who have cardiac troponin T levels above the 99th percentile but below levels that are diagnostic for myocardial infarction. The hypothesis that high-sensitivity troponin T testing followed by CCTA, as compared with other strategies, may enable safe and more efficient treatment of patients in the emergency department who are at low-to-moderate risk warrants further assessment. The generalizability of our data to clinical settings outside the United States may also be limited because of differences in the risk profile of emergency-department populations and the use of nuclear stress imaging.3

Udo Hoffmann, M.D., M.P.H.
Massachusetts General Hospital, Boston, MA
uhoffmann@partners.org

W. Frank Peacock, M.D.
Baylor College of Medicine, Houston, TX

James E. Udelson, M.D.
Tufts Medical Center, Boston, MA

Since publication of their article, the authors report no further potential conflict of interest.

References

  1. Than M, Cullen L, Reid CM, et al. A 2-h diagnostic protocol to assess patients with chest pain symptoms in the Asia-Pacific region (ASPECT): a prospective observational validation study. Lancet 2011;377:1077-1084

  2. Januzzi JL Jr, Bamberg F, Lee H, et al. High-sensitivity troponin T concentrations in acute chest pain patients evaluated with cardiac computed tomography. Circulation2010;121:1227-1234

  3. Peacock WF. The value of nothing: the consequence of a negative troponin test. J Am Coll Cardiol 2011;58:1340-1342

  • Alternative #3: Coronary CT Angiography for Acute Chest Pain

The Study concluded:

There was increased diagnostic testing and higher radiation exposure in the CCTA group, with no overall reduction in the cost of care. 

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

N Engl J Med 2012; 367:299-308 July 26, 2012DOI: 10.1056/NEJMoa1201161

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.)

http://www.nejm.org/doi/full/10.1056/NEJMoa1201161#t=abstract

REFERENCES

  1. Roe MT, Harrington RA, Prosper DM, et al. Clinical and therapeutic profile of patients presenting with acute coronary syndromes who do not have significant coronary artery disease. Circulation 2000;102:1101-1106

  2. Miller JM, Rochitte CE, Dewey M, et al. Diagnostic performance of coronary angiography by 64-row CT. N Engl J Med 2008;359:2324-2336

  3. Budoff MJ, Dowe D, Jollis JG, et al. Diagnostic performance of 64-multidetector row coronary computed tomographic angiography for evaluation of coronary artery stenosis in individuals without known coronary artery disease: results from the prospective multicenter ACCURACY (Assessment by Coronary Computed Tomographic Angiography of Individuals Undergoing Invasive Coronary Angiography) trial. J Am Coll Cardiol 2008;52:1724-1732

  4. Marano R, De Cobelli F, Floriani I, et al. Italian multicenter, prospective study to evaluate the negative predictive value of 16- and 64-slice MDCT imaging in patients scheduled for coronary angiography (NIMISCAD-Non Invasive Multicenter Italian Study for Coronary Artery Disease). Eur Radiol 2009;19:1114-1123
  5. Meijboom WB, Meijs MF, Schuijf JD, et al. Diagnostic accuracy of 64-slice computed tomography coronary angiography: a prospective, multicenter, multivendor study. J Am Coll Cardiol 2008;52:2135-2144
  6. Hoffmann U, Bamberg F, Chae CU, et al. Coronary computed tomography angiography for early triage of patients with acute chest pain: the ROMICAT (Rule Out Myocardial Infarction using Computer Assisted Tomography) trial. J Am Coll Cardiol 2009;53:1642-1650

  7. Hollander JE, Chang AM, Shofer FS, et al. One-year outcomes following coronary computerized tomographic angiography for evaluation of emergency department patients with potential acute coronary syndrome. Acad Emerg Med 2009;16:693-698

  8. Rubinshtein R, Halon DA, Gaspar T, et al. Usefulness of 64-slice cardiac computed tomographic angiography for diagnosing acute coronary syndromes and predicting clinical outcome in emergency department patients with chest pain of uncertain origin. Circulation2007;115:1762-1768

  9. Schlett CL, Banerji D, Siegel E, et al. Prognostic value of CT angiography for major adverse cardiac events in patients with acute chest pain from the emergency department: 2-year outcomes of the ROMICAT trial. JACC Cardiovasc Imaging 2011;4:481-491

  10. Goldstein JA, Chinnaiyan KM, Abidov A, et al. The CT-STAT (Coronary Computed Tomographic Angiography for Systematic Triage of Acute Chest Pain Patients to Treatment) trial. J Am Coll Cardiol 2011;58:1414-1422

  11. Litt HI, Gatsonis C, Snyder B, et al. CT angiography for safe discharge of patients with possible acute coronary syndromes. N Engl J Med 2012;366:1393-1403

  12. Shreibati JB, Baker LC, Hlatky MA. Association of coronary CT angiography or stress testing with subsequent utilization and spending among Medicare beneficiaries. JAMA2011;306:2128-2136

  13. Hoffmann U, Truong QA, Fleg JL, et al. Design of the Rule Out Myocardial Ischemia/Infarction Using Computer Assisted Tomography: a multicenter randomized comparative effectiveness trial of cardiac computed tomography versus alternative triage strategies in patients with acute chest pain in the emergency department. Am Heart J2012;163:330-338

  14. Abbara S, Arbab-Zadeh A, Callister TQ, et al. SCCT guidelines for performance of coronary computed tomographic angiography: a report of the Society of Cardiovascular Computed Tomography Guidelines Committee. J Cardiovasc Comput Tomogr 2009;3:190-204

  15. Gerber TC, Carr JJ, Arai AE, et al. Ionizing radiation in cardiac imaging: a science advisory from the American Heart Association Committee on Cardiac Imaging of the Council on Clinical Cardiology and Committee on Cardiovascular Imaging and Intervention of the Council on Cardiovascular Radiology and Intervention. Circulation 2009;119:1056-1065

  16. von Ballmoos MW, Haring B, Juillerat P, Alkadhi H. Meta-analysis: diagnostic performance of low-radiation-dose coronary computed tomography angiography. Ann Intern Med2011;154:413-420[Erratum, Ann Intern Med 2011;154:848.]

  17. Achenbach S, Marwan M, Ropers D, et al. Coronary computed tomography angiography with a consistent dose below 1 mSv using prospectively electrocardiogram-triggered high-pitch spiral acquisition. Eur Heart J 2010;31:340-346

  18. Than M, Cullen L, Reid CM, et al. A 2-h diagnostic protocol to assess patients with chest pain symptoms in the Asia-Pacific region (ASPECT): a prospective observational validation study. Lancet 2011;377:1077-1084

In the EDITORIAL by Redberg RF. Dr. Redberg, Cardiology Division, UCSF made the following points in:

Coronary CT angiography for acute chest pain. N Engl J Med 2012;367:375-376

  • Six million people present to ER annually with Acute Chest Pain, most have other diseases that Heart.
  • Current diagnostic methods lead to admission to the hospital, unnecessary stays and over-treatment – improvement of outcomes is needed.
  • Rule Out Myocardial Infarction Using Computer Assisted Tomography II (ROMICAT-II) 100 patients were randomly assigned to CCTA group or Standard Diagnosis Procedures Group in the ER which involved Stress Test in 74%.

CRITIQUE and Study FLAWS in MGH Study:

  • ROMICAT-II enrolled patients only during “weekday daytime hours, no weekend or nights when the costs are higher.
  • Assumption that a diagnostic test must be done before discharge for low-to-intermediate-risk patients is unproven and probably unwarranted.. No evidence that the tests performed let to improved outcomes.
  • Events rate for patient underwent CCTA, Stress test or no testing at al were less that 1% to have an MI, no one died. Thus, it is impossible to assign a benefit to the CCTA Group. So very low rates were observed in other studies
  • CCTA patients were exposed to substantial dose of Radiation, , contrast die,
  • Patients underwent ECG and Negative Troponin, no evidence that additional testing further reduced the risk.
  • Average age of patients: 54, 47% women.Demographic Characteristics with low incidence of CAD, NEJM, 1979; 300:1350-8
  • Risk of Cancer from radiation in younger population is higher, same in women.
  • Hoffmann’s Study: Radiation burden was clinically significant: Standard Evaluation Group: (4.7+-8.4 mSv), CCTA: (13.9+-10.4 mSv), exposure of 10 mSv have been projected to lead to 1 death from Cancer per 2000 persons, Arch Intern Med 2009; 169:2071-7
  • Middle Age women, increased risk of Breast Cancer from radiation, Arch Intern Med 2012 June 11 (ePub ahead of Print)
  • ROMICAT-II study: discharge diagnosis Acute Coronary Syndrome – less than 10%
  • CCTA Group: more tests, more radiation, more interventions tht the standard-evaluation group.
  • Choose Wisely Campaign – order test only when the benefit will exceed the risks

Dr. Redberd advocates ECG and Troponin, if NORMAL, no further testing.

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Obstructive Coronary Artery Disease diagnosed by RNA levels of 23 genes – CardioDx, a Pioneer in the Field of Cardiovascular Genomic Diagnostics

Curator: Aviva Lev-Ari, PhD, RN

UPDATED on 11/15/2013

CardioDx, Inc. Nixes IPO, Cites Unfavorable Market Conditions

11/15/2013 10:31:01 AM

 

CardioDx postpones its initial public offering, citing ‘unfavorable market conditions.’ California molecular diagnostics company CardioDx spiked its initial public offering, citing “unfavorable market conditions,” according to news reports. The 5.8-million-share offering by Palo Alto-based CardioDx was slated to raise $92 million at a share price of $14-$16 apiece. The IPO, originally scheduled for yesterday, would have seen CardioDx shares trade under the “CDX” symbol.

SOURCE

http://www.devicespace.com/news_story.aspx?NewsEntityId=315972&type=email&source=DS_111513

CardioDx had planned to use some of the funds to expand its commercial efforts, including its sales and marketing workforce; to fund operations as the company pursues more insurance coverage and reimbursement; to “conduct additional clinical and marketing activities” for the company’s Corus CAD blood-based gene expression test; to fund R&D activity; and for “general corporate purposes.” CardioDx will later specify just the how much it plans to put toward each of those activities.

Investors in the company include V-Sciences Investments, Longitude Venture Partners, Artiman Ventures, Kleiner Perkins Caufield & Byers, JP Morgan and Mohr Davidow Ventures.

SOURCE

http://www.massdevice.com/news/cardiodx-spikes-ipo

CardioDX pulls IPO, citing poor market conditions

CardioDX, led by David Levison, was one of three medical technology companies to postpone their IPOs on Thursday due to poor market conditions.

Senior Technology Reporter-Silicon Valley Business Journal
CardioDX postponed an IPO on Thursday after deciding that the market is unfavorable at this time.

 

The Palo Alto company led by CEO David Levison was one of three planned medical tech companies that postponed going public on Thursday. San Diego-basedCelladon and Monrovia-based Xencor also decided to hold off due to poor market conditions.

Redwood City pharmaceutical developer Relypsa, meanwhile, went ahead with a drastically reduced IPO that raised about half of what it had been projected for it.

CardioDX, which sells diagnostic tests for cardiovascular disease, reported total revenue in in 2012 of $2.5 million and a net loss of $25.6 million. The company expects to continue to show losses for the next several years and has an accumulated deficit through June totaling $165.9 million. As of June 30, it had $46.8 million in cash, equivalents and investments.

The company’s biggest existing stakeholder is V-Sciences Investments, a wholly owned subsidiary of Temasek Life Sciences Private Ltd., which holds 19.9 percent of outstanding shares.

Other big stakeholders are Longitude Venture Partners, with a 17.9 percent stake; Artiman Ventures, 13.9 percent; Kleiner Perkins Caufield & Byers, 9.5 percent; JP Morgan, 6.4 percent; and Mohr Davidow Ventures, 5.8 percent.

SOURCE

http://www.bizjournals.com/sanjose/news/2013/11/15/cardiodx-pulls-ipo-citing-poor-market.html

Cardiovascular MDx Firm CardioDx Files to Go Public

UPDATED on 10/14/2013

October 14, 2013

NEW YORK (GenomeWeb News) – Cardiovascular molecular diagnostics firm CardioDx has filed with the US Securities and Exchange Commission to go public with an intended offering of up to $86.3 million of common stock.

The Palo Alto, Calif.-based firm has not priced its offering yet or said how many shares it plans on offering. Bank of America Merrill Lynch and Jefferies are listed as joint book-running managers on the offering, while Piper Jaffray and William Blair are co-managers.

The company plans on listing on the Nasdaq Global Market under ticker symbol “CDX.”

In its Form S-1, CardioDx said that its tests provide healthcare professionals with “critical, actionable information to improve patient care and management,” with an initial focus on coronary artery diseases (CAD), arrhythmia, and heart failure.

Its flagship product is the Corus CAD, a gene expression-based test for assessing non-diabetic patients who display symptoms suggestive of obstructive CAD. The test was launched in 2009 and through June 30, CardioDx delivered results for more than 40,000 tests, it said.

Corus CAD received Medicare Part B coverage in August 2012, making it a covered benefit for about 48 million Medicare beneficiaries, the company added.

In 2012, CardioDx posted $2.5 million in revenues with a net loss of $25.6 million. Through the first six months of 2013, the firm had revenues $2.9 million and a net loss of $18.4 million.

It had $46.8 million in cash, cash equivalents, and investments as of June 30, it said.

In August 2012, CardioDx raised $58 million in private financing. Before that, it raised $60 million in a financing round. In 2010, GE Healthcare invested $5 million in the company as part of a Series D financing round.

David Levison heads the firm as President and CEO. Other members of the management team include CFO Andrew Guggenhime; Chief Scientific Officer Steven Rosenberg; Chief Medical Officer Mark Monane; and Chief Commercial Officer Deborah Kilpatrick.

CardioDx is the latest in a recent string of omics-related companies who have gone public or have filed to go public in the US. Cancer GeneticsNanoString Technologies, and Foundation Medicine launched their IPOs earlier this year. Meanwhile, VeracyteBiocept, and Evogene have filed to float.

UPDATED on 2/25/2013

CardioDx Announces Publication of COMPASS Study Demonstrating the Corus CAD Test Outperforms Myocardial Perfusion Imaging in Overall Diagnostic Accuracy for Obstructive Coronary Artery Disease

February 24, 2013
CardioDx Announces Publication of COMPASS Study Demonstrating the Corus CAD Test Outperforms Myocardial Perfusion Imaging in Overall Diagnostic Accuracy for Obstructive Coronary Artery Disease

Tue Feb 19, 2013 8:30am EST

– Study Highlights the Validity of Corus CAD as a First-Line Test to Help Clinicians Exclude Obstructive CAD as a Cause of the Patient’s Symptoms – PALO ALTO, Calif.,  Feb. 19, 2013

/PRNewswire/ — CardioDx, Inc., a pioneer in the field of  cardiovascular genomic diagnostics, today announced the publication of the COMPASS (Coronary  Obstruction Detection by  Molecular
Personalized Gene Expression) study in  Circulation: Cardiovascular Genetics,  a journal of the American Heart Association. 

Results of the prospective, multi-center U.S. study showed that  Corus®  CAD, a blood-based  gene expression test, demonstrated high accuracy with both a high negative predictive value (96 percent) and high sensitivity (89 percent) for assessing  obstructive coronary artery disease  (CAD) in a population of patients referred for stress testing with myocardial perfusion imaging (MPI).  The study’s authors conclude that using Corus CAD earlier in the diagnostic algorithm could reduce the number of invasive cardiac tests by more accurately evaluating the presence of obstructive coronary artery disease compared to the traditional algorithm of stress myocardial perfusion imaging (MPI) in these patients.

COMPASS enrolled stable patients with symptoms suggestive of CAD who had been referred for MPI at 19 U.S. sites.  A blood sample was obtained in all 431 patients prior to MPI and Corus CAD gene expression testing was performed with study investigators blinded to Corus CAD test results. Following MPI, patients underwent either invasive coronary angiography or coronary CT angiography, gold-standard anatomical tests for the diagnosis of coronary artery disease. 

The study was designed to provide additional independent validation of the Corus CAD test in a real-world intended use patient population of patients presenting for MPI, a common noninvasive test for CAD, and builds on the results of the previous PREDICT validation study. Corus CAD requires only a simple blood draw for testing, making it safe, convenient, and easy to administer. The study evaluated results in stable non-diabetic patients with typical or atypical symptoms suggestive of CAD and found that Corus CAD surpassed the accuracy of MPI, a test that was administered more 10 million times in the U.S. in 2010.[1]

“The evaluation of stable patients with chest pain and other symptoms suggestive of CAD is a common challenge for clinicians, accounting for as many as 10,000 outpatient visits each day,” said the publication’s lead author,  Gregory S. Thomas, M.D., M.P.H., Medical Director of the MemorialCare Heart & Vascular Institute at Long Beach Memorial Medical Center and Clinical Professor of Medicine and Director of Nuclear Cardiology Education at the  University of California-Irvine  School of Medicine. “In the U.S., MPI testing is often performed in these patients and is followed by referral to invasive coronary angiography. Based on the results of this study of the Corus CAD gene expression test, we now have a reliable diagnostic approach for evaluating patients with symptoms of obstructive CAD.  With its high sensitivity and negative predictive value, Corus CAD may help clinicians accurately and efficiently exclude the diagnosis of obstructive CAD early in the diagnostic pathway, so they can assess for other causes of their patients’ symptoms.”

The pre-specified primary endpoint of the COMPASS study was the receiver-operator characteristics (ROC) analysis to evaluate the ability of Corus CAD to identify coronary arterial blockages of 50 percent or greater by quantitative coronary angiography.  Corus CAD outperformed MPI in overall diagnostic accuracy for assessing obstructive CAD, with an area under the curve (AUC) of 0.79 for the Corus CAD test compared to MPI site and core-lab read AUCs of 0.59 and 0.63 respectively (p<0.001).  In addition, Corus CAD performed better than MPI in sensitivity (89 percent vs. 27 percent, p<0.001) and negative predictive value (96 percent vs. 88 percent, p<0.001) parameters, thus demonstrating excellent performance for excluding obstructive CAD as the cause of a patient’s symptoms.  The COMPASS results corroborated earlier findings from the PREDICT multicenter U.S. validation study[2] demonstrating that the Corus CAD score is proportional to coronary artery stenosis severity.

“Corus CAD can help solve an enormous unmet need in healthcare by providing clinicians with a safe, convenient and reliable tool to help evaluate common patient symptoms and triage them more appropriately for subsequent therapy or additional testing,” said  David Levison, President and CEO of CardioDx.  “In addition to its higher diagnostic accuracy, Corus CAD holds potential to reduce a major healthcare expense category – unnecessary noninvasive imaging and/or invasive coronary angiography procedures and their associated risks and side effects. We have worked closely with leading clinicians to build a solid clinical and economic foundation for Corus CAD, leading to its growing acceptance in the medical and payer communities as evidenced by the more than 35,000 tests performed to date and Medicare’s decision to cover the test.”

 SOURCE:

http://www.fiercemedicaldevices.com/press-releases/cardiodx-announces-publication-compass-study-demonstrating-corus-cad-test-o

CardioDx is promoting yet another post-marketing study whose data may help the company’s gene expression test for obstructive coronary artery disease reach more patients, better compete with the standard of care and also build vital market share.

Executives at the California-based 2012 Fierce 15 company say they wanted more data on Corus CAD‘s real-world use, building on its previous PREDICT validation trial as a result. The test has been on sale commercially since 2009 and won crucial Medicare reimbursement last fall. Chief Scientific Officer Steven Rosenberg told FierceMedicalDevices via email that the results from the latest study pointed in a number of positive directions.

“It demonstrates performance at least as good as that seen in the PREDICT study, but in the population the Corus CAD is indicated for,” Rosenberg said, “It shows significantly higher performance for obstructive CAD than MPI, which is the most common non-invasive imaging test used in this regard.”

A 431-patient clinical study of the blood diagnostic rated the test with a 96% negative predictive value and 89% high sensitivity, in assessing the condition in patients who were referred for stress testing with myocardial perfusion imaging (MPI). (Last November, CardioDx heralded similar results from another study using Corus CAD on 98 geriatric patients.) Details are published in the journal Circulation: Cardiovascular Genetics.

The blood test, conducted at 19 U.S. sites through multiple academic institutions, determined that using Corus CAD earlier in the diagnostic process better assessed the presence of coronary artery disease versus MPI. This might encourage doctors to cut back on invasive, more expensive cardiac tests by ruling out obstructive CAD sooner. In other words, determining a patient doesn’t have obstructive CAD eliminates the need for diagnostic procedures such as coronary angiography or coronary CT angiography, the company explains.

Post-marketing studies are increasingly important in today’s health care market, with the need to demonstrate the utility of a device or diagnostic in as most detailed a way possible. And it’s not just boosting the standard of care; the Affordable Care Act means value matters, too, more than ever before. Success with this mission can help broaden market share and also increase the chance of private as well as government insurance coverage. Additionally, new post-marketing trials can also set the stage for expanded indications down the line.

SOURCE:

http://www.fiercemedicaldevices.com/story/cardiodx-cad-dx-passes-another-post-marketing-test/2013-02-24?utm_medium=nl&utm_source=internal

A Blood Based Gene Expression Test for Obstructive Coronary Artery Disease Tested in Symptomatic Non-Diabetic Patients Referred for Myocardial Perfusion Imaging: The COMPASS Study

  1. Gregory S. Thomas1*,
  2. Szilard Voros2,
  3. John A. McPherson3,
  4. Alexandra J. Lansky4,
  5. Mary E. Winn5,
  6. Timothy M. Bateman6,
  7. Michael R. Elashoff7,
  8. Hsiao D. Lieu7,
  9. Andrea M. Johnson7,
  10. Susan E. Daniels7,
  11. Joseph A. Ladapo8,
  12. Charles E. Phelps9,
  13. Pamela S. Douglas10 and
  14. Steven Rosenberg7

+Author Affiliations


  1. 1Long Beach Memorial Medical Center, Long Beach & University of California, Irvine, CA

  2. 2Stony Brook University Medical Center, Stony Brook, NY

  3. 3Vanderbilt University, Nashville, TN

  4. 4Yale University School of Medicine, New Haven, CN

  5. 5Scripps Translational Science Institute, La Jolla, CA

  6. 6University of Missouri, Kansas City, MO

  7. 7CardioDx, Inc., Palo Alto, CA

  8. 8New York University School of Medicine, New York, NY

  9. 9University of Rochester, Rochester, NY

  10. 10Duke Clinical Research Institute, Duke University, Durham, NC
  1. * MemorialCare Heart and Vascular Institute, Long Beach Memorial Medical Center, 2801 Atlantic Avenue, Long Beach, CA 90806 gthomas@mimg.com

Abstract

Background—Obstructive coronary artery disease (CAD) diagnosis in symptomatic patients often involves non-invasive testing before invasive coronary angiography (ICA). A blood-based gene expression score (GES) was previously validated in non-diabetic patients referred for ICA but not in symptomatic patients referred for myocardial perfusion imaging (MPI).

Methods and Results—This prospective multi-center study obtained peripheral blood samples for GES before MPI in 537 consecutive patients. Patients with abnormal MPI usually underwent ICA; all others had research coronary CT-angiography (CTA), with core laboratories defining coronary anatomy. A total of 431 patients completed GES, coronary imaging (ICA or CTA), and MPI. Mean age was 56±10 (48% women). The pre-specified primary endpoint was GES receiver-operator characteristics (ROC) analysis to discriminate ≥50% stenosis (15% prevalence by core laboratory analysis). ROC curve area (AUC) for GES was 0.79 (95% CI 0.73-0.84, p<.001), with sensitivity, specificity, and negative predictive value (NPV) of 89%, 52%, and 96%, respectively, at a pre-specified threshold of ≤15 with 46% of patients below this score. The GES outperformed clinical factors by ROC and reclassification analysis and also showed significant correlation with maximum percent stenosis. Six-month follow-up on 97% of patients showed that 27/28 patients with adverse cardiovascular events or revascularization had GES >15. Site and core-lab MPI had AUCs of 0.59 and 0.63, respectively, significantly less than GES.

ConclusionsA GES has high sensitivity and NPV for obstructive CAD. In this population clinically referred for MPI, the GES outperformed clinical factors and MPI.

Clinical Trial Registration Information—www.clinicaltrials.gov; Identifier: NCT01117506.

  • Received June 6, 2012.
  • Revision received January 15, 2013.
  • Accepted February 5, 2013.

http://circgenetics.ahajournals.org/content/early/2013/02/15/CIRCGENETICS.112.964015.abstract?sid=74741525-8453-460e-8407-f11022fe9a24

http://www.bizjournals.com/sanfrancisco/blog/biotech/2012/08/cardiodx-corus-medicare-heart-disease.html

CardioDx heart disease test wins Medicare coverage

San Francisco Business Times by Ron Leuty, Reporter

Date: Wednesday, August 8, 2012, 4:00am PDT

CardioDx's test for obstructive heart disease will be covered by Medicare retroactive to Jan. 1.
Photo supplied by CardioDx

CardioDx’s test for obstructive heart disease will be covered by Medicare retroactive to Jan. 1.

Reporter- San Francisco Business Times
 

A key national Medicare contractor will cover the cost of a coronary artery disease test developed by CardioDx Inc.

The move is important for Palo Alto-based CardioDx because private insurers tend to follow the federal government’s Medicare health insurance program. The company has had to seek reimbursement on a case-by-case basis with those private insurers since its Corus CAD gene expression test hit the market in June 2009.

The decision disclosed Tuesday by Palmetto GBA, a national contractor that administers Medicare benefits in Columbia, S.C., means that Medicare will cover the test for as many as 40 million enrollees. Coverage is retroactive to Jan. 1.

Corus CAD is a shoebox-size kit that uses a simple blood draw to measure the RNA levels of 23 genes. Using an algorithm, it then creates a score that determines the likelihood that a patient has obstructive coronary artery disease.

“By providing Medicare beneficiaries access to Corus CAD, this coverage decision enables patients to avoid unnecessary procedures and risks associated with cardiac imaging and elective invasive angiography, while helping payers address an area of significant healthcare spending,” CardioDx President and CEO David Levison said in a press release.

The decision represents the latest Medicare-coverage win for Bay Area diagnostic test makers. Palmetto earlier this year opted to cover the Afirma gene expression test from South San Francisco’s Veracyte Inc. to diagnosis thyroid nodules, and last summer Palmetto said it would cover Redwood City-based Genomic Health Inc.’s (NASDAQ: GHDX)colon cancer recurrence test.

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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

N Engl J Med 2012; 367:299-308 July 26, 2012

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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