ROMICAT-II Provokes Opposing Views On CT Angiography In The Emergency Department 1

For patients with suspected acute coronary syndromes (ACS) CT angiography (CTA) compared to standard treatment can reduce the time in the emergency department (ED), according to results of the ROMICAT-II (Rule Out Myocardial Infarction/Ischemia Using Computer-Assisted Tomography) trial published in the New England Journal of Medicine. However, CTA resulted in more tests being performed and increased radiation exposure.

1000 patients with possible ACS but without ECG signs of ischemia or a positive troponin test were randomized to either CTA or standard treatment. The primary endpoint of the study, the mean length of hospital stay, was reduced from 30.8 hours in the standard evaluation group to 23.2 hours in the CTA group, a highly significant reduction of 7.6 hours (p<<0.001). In addition, many more patients in the CTA group were discharged directly from the ED (47% vs 12%, P<0.001). There were no cases of undetected ACS in either group and very few major adverse cardiovascular events (2 vs 6, p=0.18). Half of the patients in the CTA group were discharged within 8.6 hours, compared with only 10% of the controls.

ED and hospital costs were similar in both groups. Radiation exposure was increased in the CTA group (13.9 mSv vs 4.7 mSv) and more diagnostic tests were performed  in the CTA group.

The authors concluded that their “data should allow providers and patients to make informed decisions about the use of this technology as an option for evaluation when symptoms are suggestive of an acute coronary syndrome.”

Schrödinger’s ROMICAT

In contrast to the neutral presentation of the authors in the NEJM paper, strikingly different positions about the utility of CT angiography were taken in an accompanying editorial by Rita Redberg and a press release issued by the National Heart Lung and Blood Institute, which sponsored the study.

In her editorial, Redberg writes:

 Although shorter lengths of stay in the hospital are highly desirable, especially from the patient’s point of view, the ROMICAT-II study reveals a deeper flaw in the approach to chest pain in the emergency department. The underlying assumption… is that some diagnostic test must be performed before discharging these low-to-intermediate-risk patients from the emergency department. This assumption is unproven and probably unwarranted. The rationale for any test, as compared with no testing, should be that it will lead to an improved outcome, and here there is no evidence that the tests performed led to improved outcomes.

Redberg points out that the very low (under 1%) rate of patients who actually had an MI in the study means “that it is impossible to know whether the CCTA groups received any benefit whatsoever.” Further, factoring in radiation doses  both from CTA and nuclear stress tests and adverse reactions to contrast dye, “clinicians may legitimately ask whether the tests did more harm than good.”

For patients like those in ROMICAT II, with normal ECG findings and negative troponin tests, “multiple studies show no evidence that any additional testing further reduces that risk.”Although CTA can reduce length of stay in the hospital compared to standard care, “it is even faster to discharge these patients without any additional diagnostic test after determining that their ECG findings and troponin levels are normal.” She concludes:

In short, the question is not which test leads to faster discharge of patients from the emergency department, but whether a test is needed at all.”

By contrast, the NHLBI press release focuses exclusively on the benefits of CTA and lacks any significant discussion of its potential limitations, as presented in the NEJM paper and as discussed in detail by Redberg. The press release quotes Susan Shurin, the acting director of the NHLBI:

Identifying the underlying cause of chest pain more quickly with CT scans could allow medical care providers to better allocate limited resources to the patients who are most in need of treatment.

The principal investigator of the study, Udo Hoffmann, says that ROMICAT II can “help health care providers and patients make better informed decisions by knowing the risks and potential benefits of using CT scans to more quickly diagnose acute coronary syndrome,” but he glosses over the risks and then focuses on the benefits:

“It can be a relief to patients with chest pain to quickly know they are not having a heart attack and that they can spend the night at home, instead of in a hospital bed.”

Finally, the press release gives short shrift to the radiation issue:

Participants in the CT group were exposed to more radiation than those in the standard screening group, though the study authors suggested that future CT scans could be done using less radiation, which could help lower exposure without sacrificing accuracy.


Here is a press release from the NHLBI:

Heart CT scans may help emergency room personnel more quickly assess patients with chest pain

Adding computed tomography (CT) scans to standard screening procedures may help emergency room staff more rapidly determine which patients complaining of chest pain are having a heart attack or may soon have a heart attack, and which patients can be safely discharged, according to a study funded by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health.

Researchers in the study focused on a condition known as acute coronary syndrome, which includes heart attacks and unstable angina (chest pain), a condition that often progresses to a heart attack.  This syndrome occurs when narrowed or blocked coronary arteries prevent oxygen-rich blood from reaching the heart muscle. Since chest pain has many causes, patients are often unnecessarily admitted to the hospital before it is determined that their chest pain is not due to acute coronary syndrome or other serious conditions.

CT angiography is a type of heart X-ray exam using a device that creates pictures of the coronary arteries, allowing physicians to see whether arteries have major blockages.

“Quickly figuring out which emergency room patients have acute coronary syndrome and which patients can go home because they don’t have a serious condition is a significant challenge for U.S. hospitals,” said Susan B. Shurin, M.D., acting director of the NHLBI.  “Identifying the underlying cause of chest pain more quickly with CT scans could allow medical care providers to better allocate limited resources to the patients who are most in need of treatment.”

The study results suggest that CT scans allow hospitals to send many patients with chest pain home sooner without compromising their safety. The average length of hospital stay was 23.2 hours for those who underwent CT scans, compared to 30.7 hours for those who underwent standard screening procedures alone. Half of the patients who received a CT scan were discharged in 8.6 hours or less. In contrast, half of the patients in the standard evaluation group were sent home in 26.7 hours or less.

Even with shorter hospital stays in the group that received CT scans, the researchers did not miss any cases of acute coronary syndrome among those participants. After 28 days of follow-up, there was no significant difference in serious cardiovascular events between the two groups.

The study, which appears in the July 26 New England Journal of Medicine, was part of an NHLBI-funded program called Rule Out Myocardial Infarction/Ischemia Using Computer-Assisted Tomography (ROMICAT-II).

Led by investigators at Massachusetts General Hospital in Boston, the researchers randomized participants with suspected acute coronary syndrome to receive standard emergency room screening evaluations alone or to standard evaluations plus cardiac CT angiography.

The researchers studied 1,000 participants between 40 and 74 years old in nine U.S. hospitals. Participants were eligible to enroll in the trial if they showed symptoms suggestive of acute coronary syndrome but no prior history of heart disease or evidence of heart damage on their electrocardiogram (ECG) tests or blood tests.

“The results from this study should help health care providers and patients make better informed decisions by knowing the risks and potential benefits of using CT scans to more quickly diagnose acute coronary syndrome,” said Udo Hoffmann, M.D., M.P.H., the study’s principal investigator at Massachusetts General Hospital and Harvard Medical School, Boston. “It can be a relief to patients with chest pain to quickly know they are not having a heart attack and that they can spend the night at home, instead of in a hospital bed.”

Participants in the CT group were exposed to more radiation than those in the standard screening group, though the study authors suggested that future CT scans could be done using less radiation, which could help lower exposure without sacrificing accuracy.

Overall costs were similar in the two treatment groups.

The NHLBI funded ROMICAT-II through the following grants: HL092040, HL092022, HL098370, and HL093896. Learn more about this clinical trial (NCT01084239) at: http://clinicaltrials.gov/ct2/show/NCT01084239

For more information or to schedule an interview, contact the NHLBI Communications Office at 301-496-4236.

Supplemental resources:

Part of the National Institutes of Health, the National Heart, Lung, and Blood Institute (NHLBI) plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available online athttp://www.nhlbi.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIH…Turning Discovery Into Health

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One comment

  1. The ROMICAT II study is very important, demonstrating much faster and efficient discharge from the ER using coronary CTA, but without missing any acute coronary syndromes. There are obvious benefits to patients (sleeping in own bed rather than hospital bed) and to the hospitals. Although hospital charges were similar between the two groups, the actual cost to hospitals must be less or potentially less if the patients leave the ER and hospital earlier, freeing up beds and manpower.

    Rita Redberg’s comments are interesting, but suggest a different study rather than focusing directly on the study presented. It might be interesting to compare the standard protocol, coronary CTA protocol, and outpatient testing protocol in lower risk patients. From a patient satisfaction standpoint and medicolegal standpoint, however, will it be OK to delay the evaluation over several weeks? Will there be a bunch of missed MI’s or deaths? This is a different set of questions.

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