ROMICAT II Published: Coronary CT in the Emergency Department Saves Time Screening for ACS<

July 26, 2012

July 26, 2012 (Boston, Massachusetts) — The Rule Out Myocardial Infarction Using Computer Assisted Tomography II (ROMICAT II) study, a trial showing that the use of coronary computed-tomography angiography (CCTA) to screen chest-pain patients in the emergency department reduces overall patient time in the hospital and costs about the same overall as the current standard approach, is now published in the July 26, 2012 New England Journal of Medicine [1].

In the study, first presented at the American College of Cardiology 2012 Scientific Sessions in Chicago, IL and reported by heartwire at that time, investigators, led by Dr Udo Hoffman (Massachusetts General Hospital, Boston), randomized 1000 chest-pain patients with suspected acute coronary syndrome on a 1:1 ratio to either a CCTA screening approach or standard care left to the discretion of the emergency-department physician.

Overall, ROMICAT II showed that the CCTA-based strategy reduced the average time in the hospital by 7.6 hours and that significantly more patients were discharged directly from the emergency department (47% vs 12%, p<0.001).

Here there is no evidence that the tests performed led to improved outcomes.

 Despite the trial's meeting the primary end point, Dr Rita Redberg (University of California, San Francisco), who wrote an editorial accompanying the publication of ROMICAT II [2], comes down hard on the results and specifically questions whether any additional testing in the emergency department would be needed in this patient population. She notes that patients who have a normal ECG and negative troponin levels are at low risk for cardiac events, and multiple studies suggest no benefit for additional testing in the group. Moreover, the average age of patients in ROMICAT II was 54 years, and 47% of the subjects were women.

"On the basis of age, sex, and history of chest pain alone, the pretest probability is generally not high for coronary artery disease in patients with these demographic characteristics," writes Redberg. "Furthermore, the risk of cancer from radiation is higher in younger age groups and among women."

The ROMICAT II Study

As reported previously by heartwire at the ACC meeting, investigators note that 50% of patients in the CCTA group were discharged within 8.6 hours of presenting to the hospital compared with just 10% of patients in the standard-evaluation arm. Importantly, there were no undetected acute coronary syndromes and no difference in major adverse cardiovascular events at 28 days.

Regarding safety, the cumulative radiation exposure from CCTA was 11.3 mSv, and this was significantly higher than in patients who underwent standard evaluations. In addition, there was increased use of diagnostic testing in patients randomized to the CCTA arm. The cumulative mean cost of care was similar in the CCTA group and standard evaluation group ($4289 vs $4060, respectively; p=0.65).

Based on the results, Hoffmann and colleagues conclude that CCTA, incorporated early into a clinical evaluation strategy in patients presenting to the hospital with chest pain suggestive of an acute coronary syndrome, "improves the efficiency of clinical decision making as compared with a standard evaluation in the emergency department." They add that the improvement "appeared to be accomplished safely, without putting patients at greater risk for undetected acute coronary syndromes."

For Redberg, however, the underlying assumption that some diagnostic test must be performed before these low- to intermediate-risk patients are discharged from the hospital is "unproven and probably unwarranted." She writes: "The rationale for any test, as compared with no testing, should be that it will lead to improved outcome, and here there is no evidence that the tests performed led to improved outcomes." Given that the rates for major cardiac events is so low--less than 1% for MI and no deaths--it is impossible to know whether the CCTA patients received any benefit whatsoever.

While the use of CCTA led to a faster discharge from the hospital, "it is even faster to discharge these patients without any additional diagnostic test after determining that their ECG findings and troponin levels are normal," writes Redberg. "Thus, with no evidence of benefit and definite risks, routine testing in the emergency department of patients with low to intermediate risk of acute coronary syndrome should be avoided." Judicious clinical follow-up, she adds, is safer and in the best interest of the majority of these patients.

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