ROMICAT II trial indicates coronary CT angiography (CCTA) as a safe and time-efficient non-invasive modality to evaluate patients with chest pain in the Emergency Department, when compared to the current standard approach.

 

ROMICAT II (Rule Out Myocardial Ischemia/Infarction Using Computer Assisted Tomography), is a multicenter randomized comparative effectiveness trial of CCTA versus standard triage evaluation in acute chest pain patients in the Emergency Department. This study, lead by Dr. Udo Hoffmann from the Massachusetts General Hospital, examines whether integrating CCTA improves the efficiency of the management of low-intermediate risk patients. The trial involved 1000 patients, who entered the Emergency Department (ED) with chest pain and after initial evaluation, were randomly assigned to either a CCTA scan, or to standard triage evaluation. Results indicated that the patients diagnosed with a CT scan reduced their mean average time spent in the hospital by 7.6 hours. Fifty percent of patients receiving the CCTA scan were safely discharged within nine hours, while only fifteen percent of patients receiving standard of care as a diagnosis were discharged in that time period. The reduced time produced an Emergency department cost savings for the CCTA group of 18% percent, compared to the standard of care diagnosis ($2,101 vs. $2,566). However, the mean cost of care including hospital stay was similar among both groups ($4,026 vs. $3,874). Long-term cost data was not available which would allow to determine whether negative CCTA results would allow fewer repeat visits to the ED and hospitalizations over a longer time period.

 

One critical piece of information that may have not been emphasized enough is that the rate of adverse cardiovascular events (MACE) at 28 days in the standard of care ED evaluation was 1.2% (including four myocardial infarctions and two cases of unstable angina for which percutaneous coronary intervention was required). The coronary CTA approach had only two events (0.4%) at 28 days; however, in both cases coronary CT angiography established correctly clinically significant coronary artery disease during the initial hospitalization, but both patients had negative stress tests and were initially treated medically. It is important to emphasize that the 1.2% rate of MACE in the standard of care group is above the "acceptable" rate (<1%) of missing a patient with acute coronary syndrome in the emergency department setting.

 

While the randomized comparison in this study showed increased cumulative radiation dose in the CCTA group, it is important to emphasize that nearly all patients in the CCTA group (97%), but only 33% of patients randomly assigned to standard evaluation (33%) were exposed to radiation from an imaging test or procedure. It is very important to note that the mean radiation dose from CCTA was 11.3±5.3 mSv and was lower than single-photon-emission CT (14.1±4.8 mSv, P<0.001). It is critical to emphasize that newer techniques to minimize radiation exposure became available in the past three years and nowadays diagnostic-quality CCTA can be performed routinely in clinical practice with doses of less than 5 mSv. SCCT highly recommends and promotes the use of radiation dose reduction techniques in clinical practice.

 

"This study adds to the growing body of evidence that assessment of low to intermediate risk patients with coronary CT angiography improves efficiency in the ER. Because it is highly accurate in selecting those without coronary disease, this test also removes the uncertainty that patients and physicians alike often continue to feel after these patients are evaluated with the standard approach to acute chest pain." says Dr. John Lesser, president of SCCT.

 

"The results of ROMICAT II trial support prior available evidence from two other large randomized trials (ACRIN-PA and CT-STAT) confirming the safety of a negative CTA to discharge patients, leading to decrease length of stay and potential cost-savings. Cautious implementation of this modality in the ER setting is needed to ensure proper patient selection and preparation, implementation of radiation dose reduction techniques and assurance of available expertise and coverage," says Dr. Ricardo C. Cury, Chairman of Radiology and Director of Cardiac Imaging, Baptist Hospital of Miami and Baptist Cardiac and Vascular Institute.

 

"Efficiency matters. Any blocked emergency Department bed, results in another patient waiting longer. Freeing beds earlier saves lives in many studies. If CTA identifies patients without CAD during the first visit, we believe that these patients will be discharged when (and if) they come back since they won't develop CAD in a year." says Dr. Judd Hollander, Professor in the Department of Emergency Medicine at the University of Pennsylvania.