Rule Out Myocardial Ischemia/Infarction Using Computer Assisted Tomography - ROMICAT-II

Description:

The goal of the trial was to evaluate a strategy of cardiac computed tomography (CT) compared with standard emergency department (ED) evaluation among patients with symptoms suggested of acute coronary syndrome (ACS).

Hypothesis:

 Cardiac CT will improve the effectiveness of clinical decision making.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Patients 40-74 years of age with >5 minutes of chest pain within the last 24 hours
  • Sinus rhythm
  • Ability to hold breath for 10 seconds

    Number of screened applicants: 1,272
    Number of enrollees: 1,000
    Duration of follow-up: 28 days
    Mean patient age: 54 years
    Percentage female: 48%

Exclusions:

  • Ischemic electrocardiogram changes
  • Known coronary artery disease
  • >6 hours from emergency presentation to time of consent
  • Body mass index >40 kg/m2
  • Renal insufficiency
  • Elevated troponin level
  • Cocaine use within last 48 hours
  • Hemodynamic or clinical instability
  • Any contraindication to CT angiography

Primary Endpoints:

  • Length of hospital stay

Secondary Endpoints:

  • Rate of missed ACS within 72 hours after discharge from ED
  • MACE (death, myocardial infarction, unstable angina, urgent revascularization) within 28 days
  • Periprocedural complications
  • Rate of ED discharge
  • Time to diagnosis
  • Resource utilization
  • Costs
  • Cumulative radiation exposure

Drug/Procedures Used:

Patients with chest pain suggestive of ACS (initial negative electrocardiogram and cardiac enzymes) were randomized to cardiac CT (n = 501) versus standard ED evaluation (n = 499).

Principal Findings:

Overall, 1,000 patients were randomized. The mean age was 54 years, 48% were women, 17% had diabetes, and 54% had 2-3 major cardiovascular risk factors. The mean blood pressure was 144/83 mm Hg, the mean heart rate was 78 bpm, and the mean body mass index was 29 kg/m2.

The primary outcome, mean length of stay, was 23 hours in the cardiac CT group versus 31 hours in the standard ED care group (p < 0.001).

Periprocedural complications: 0.4% versus 0% (p = 0.25), major adverse cardiac events (MACE): 0.4% versus 1.2% (p = 0.18), direct discharge from the ED: 47% versus 12% (p < 0.001), time to diagnosis: 10 versus 19 hours (p < 0.001), invasive coronary CT: 12% versus 8.0% (p = 0.06), cumulative radiation exposure: 14 versus 5.3 mSv (p < 0.001), and total costs: $4,026 versus $3,874 (p = 0.75), respectively. There was no missed diagnosis of ACS in either group. There was more downstream diagnostic testing in the CT (p < 0.001).

Among patients who underwent cardiac CT, ACS was detected during hospitalization in 7.8% (n = 37; 14% with myocardial infarction and 86% with unstable angina). High-risk plaque features (positive remodeling, low Hounsfield units, napkin ring sign, or spotty calcium) were a significant predictor of ACS (odds ratio, 8.9; p = 0.006), after adjusting for lesion stenosis and clinical risk assessment.

Interpretation:

Among patients with symptoms suggestive of ACS and multiple risk factors for coronary artery disease, the use of cardiac CT improved the efficiency of clinical decision making. This technology reduced length of stay and time to diagnosis, while increasing the proportion of patients discharged directly from the ED. Costs were similar between groups; however, cumulative radiation exposure was higher with cardiac CT.

MACE was low in both groups and there was no missed diagnosis of ACS in either group. Detection of high-risk plaque features appeared to be predictive of ACS. Further studies are needed to determine the effect of cardiac CT on clinical outcomes. These results do not apply to older patients (>74 years) presenting with possible ACS.

References:

Puchner SB, Liu T, Mayrhofer T, et al. High-risk plaque detected on coronary CT angiography predicts acute coronary syndromes independent of significant stenosis in patients with acute chest pain: results of the ROMICAT II trial. J Am Coll Cardiol 2014;64:684-92.

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.

Presented by Dr. Udo Hoffmann at ACC.12 & ACC-i2 with TCT, Chicago, IL, March 27, 2012.

Clinical Topics: Acute Coronary Syndromes, Noninvasive Imaging, Atherosclerotic Disease (CAD/PAD)

Keywords: Odds Ratio, Coronary Artery Disease, Myocardial Infarction, Acute Coronary Syndrome, Decision Making, Blood Pressure, Risk Factors, Electrocardiography, Constriction, Pathologic, Emergency Service, Hospital, Heart Rate, Calcium, Length of Stay, Body Mass Index, Tomography, Chest Pain, Risk Assessment, Diabetes Mellitus


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