Presentation on theme: "Usefulness of Coronary Computed Tomography Angiography For Early Triage of Patients with Acute Chest Pain - The Rule Out Myocardial Infarction Using Computer."— Presentation transcript:
1 Usefulness of Coronary Computed Tomography Angiography For Early Triage of Patients with Acute Chest Pain - The Rule Out Myocardial Infarction Using Computer Assisted Tomography (ROMICAT) TrialUdo Hoffmann, Fabian Bamberg, Claudia U. Chae, John H. Nichols, Ian S. Rogers, Sujith K. Seneviratne, Quynh A. Truong, Ricardo C. Cury, Suhny Abbara, Michael D. Shapiro, Jamaluddin Moloo, Javed Butler, Maros Ferencik, Hang Lee, Ik-Kyung Jang, Blair A. Parry, David F. Brown, James E. Udelson, Stephan Achenbach, Thomas J. Brady, John T. NagurneyDepartment of Radiology, Emergency Medicine, and Cardiology Division, Massachusetts General Hospital and Harvard Medical School, Boston MA
2 DisclosuresResearch Grants: Siemens Medical Solutions, Amersham/GE Healthcare, Bracco Diagnostics, NIH Advisory Boards: Vital Images, Bayer Healthcare/Siemens Medical Solutions
3 Improvement of the initial ED evaluation needed! Early Risk Stratification and Triage in the ED6 Million present with chest pain to ED annuallyECG, initial biomarkers, and clinical presentation and traditional risk factors – no safe triage possible (Nagurney, JAMA 2006)low threshold to admit, >80% have no ACS, $8Billion annually healthcare cost1-5% of missed ACS cause 20% of ED malpractice costsImprovement of the initial ED evaluation needed!
4 Preliminary coronary CTA Studies coronary MDCT is feasible in the acute care settinglow to intermediate risk patients - absence of CAD has 100% NPV for ACS – found in 40% of patientsHoffmann et al Circulation 2006very low risk patients - CT may be cost saving alternative to myocardial perfusion stress testingRaff et al JACC 2007normal coronary CTA has excellent NPV for MACE within 15 monthsRubinshtein et al. Circulation 2007
5 Confirmation in larger cohorts Safety of Stenosis based Triage Remaining Questions for Patient ManagementConfirmation in larger cohortsSafety of Stenosis based TriageRelevance of detected StenosisIncremental Value of non-calcified plaque for exclusion of ACS
6 Determine the diagnostic accuracy of these findings for ACS ROMICAT I - Specific AimsDetermine the prevalence of coronary atherosclerotic plaque and stenosis in patients with acute chest pain and low to intermediate for ACSDetermine the diagnostic accuracy of these findings for ACSDetermine whether this information is incremental to current risk assessment
7 Index Hospitalization ROMICAT I – Study DesignObservational, double-blinded Cohort StudyCardiac CT Analysis - blinded to caregiver and subjectsPresence of atherosclerotic plaque per coronary segmentCalcified plaqueNon-calcified plaquePresence of significant coronary artery stenosis (>50%)Neg. ECGNeg. TropStandard clinical careAcute Chest Pain6 month FUIndex HospitalizationEDt
8 ROMICAT I - Methods positive initial Troponin Diagnostic ECG changes Inclusion Criteria- >5 min of chest pain <24h- Normal initial Biomarker- Admitted to Rule out MI- Normal sinus rhythmExclusion Criteriapositive initial TroponinDiagnostic ECG changesCreatinine >1.3 mg/dl- Known CADCoronary MDCT- 64-slice MDCT (Siemens, Forchheim, Germany)- Beta-Blocker if HR>65 bpm, Nitro- ~20 ml + 80ml contrast agent (Iodhexodol 320)- tube current: ~850 mAs, tube voltage: 120 kVPrimary EndpointACS* (NSTEMI or UAP) during Index Hospitalization and MACE during 6-month follow-up adjudicated by independent committee*According to AHA/ACC/ESC Guidelines
9 18 month Screening and Enrollment Protocol Eligible Subjects (n = 658)Physician Denied (n = 19)Patient Refusal (n = 124)Missed to Ongoing Recruitment (n = 103)Enrolled Subjects (n = 412)Incomplete Scan (n=17)Interference with Clinical Care (n = 10)Claustrophobia/Nausea (n = 3)Contrast Extravasation (n = 3)Scanner Malfunction (n = 1)Complete Scan (n=27)History of Stent Placement (n = 10)History of CABG (n = 17)Study Population (n = 368)
10 ROMICAT I – Demographics and Risk Factors Age (years, mean SD)52.7±12Male Gender (n, %)223 (61%)Race (n, %)African AmericanCaucasianAsiansOthers31 (8%)313 (85%)4 (1%)20 (6%)No. of risk factors (median, IQR)2 (1)TIMI Score (low/intermediate/high) in %94.3/ 5.4/ 0.3ACS during index hospitalization (%, n)Unstable angina pectoris (%, n) Myocardial infarction (%, n)23 (74%)8 (26%)MACE during six month follow- up (%, n):Recurrent chest pain:Outpatient evaluation (PCP)Readmission without testingReadmission with testing68 (18%)50 (74%)5 (7%)13 (19%)
11 ROMICAT I – Prevalence of Plaque and Stenosis CAD categories with relevance for early triage of patients with ACP in the EDNon-obstructive Plaque %N= 115/368No CAD %(no plaque and no stenosis)N= 185/368Significant stenosis detected or not excluded %N= 68/368
12 Nonobstructive Plaque Significant stenosis detected or not excluded ROMICAT I – CAD and ACSNo CADNo ACSNonobstructive Plaque7 ACSnon-stenotic ACSsmall vessel diseaseSignificant stenosis detected or not excluded24 ACS
13 NSTEMI with significant stenosis 40-year old male who presented 3 hours after the onset of substernal chest pain, inconclusive initial evaluation in the ED, Troponin positive 8 hours after ED presentation, underwent invasive coronary angiography with stenting of an 80% mid LAD
15 NSTEMI with small vessel disease 59-year old female with typical chest pain, non-diagnostic ECG and negative serial Troponin, coronary CTA – plaque in OM 1, invasive coronary angiography demonstrates 95% stenosis of the PDA
18 Results – Stenosis and ACS specificity of significant stenosis for ACS was lower in subjects ≥65 years of age (58% vs. 91%) because of increased prevalence of CAC (84% vs. 39%; p<0.0001)in 34 patients a significant stenosis was detected20 had ACS14 had no ACS or MACE after 6 monthssevere RCA lesion, no regional LV dysfunction, normal stress SPECT study,diagnosis of ‘non cardiac chest pain’.
19 Incremental Value of coronary CTA to TIMI AUC for the detection of ACS during index hospitalizationExtent of plaque, presence of stenosis, TIMI risk score (AUC: 0.88, 0.82 vs. 0.63; respectively, all p<0.0001).
20 Summaryconfirmation - Absence of any CAD in 50% of patients - 100% NPV for ACS – may enable early safe and early discharge from the EDtriage criterion of 50% stenosis is not perfect because of non-stenotic ACS and limited spatial resolution of coronary CTAsignificant stenosis is detected in 10% of patients by coronary CTA – about 40% of these were discharged with a diagnosis of non-cardiac chest painincremental value of non- calcified plaque for early triage is limited
21 Thank you! Cardiac MR PET CT Program Fabian Moselewski, Maros Ferencik, Suhny Abbara, Ricardo C. Cury, Thomas J. Brady, Javed Butler, Nina Dannemann, Michael Shapiro, Sujith Seneviratne, Ian Rogers, John Nichols, Ian Rogers, Quynh Truong, Christopher Schlett, Sam Lehman, Sujith Seneviratne, Ron Blankstein, Khuram NasirDepartment of Emergency MedicineJohn T. Nagurney, David F.M. Brown, Blair ParryCardiology DivisionClaudia U. Chae, Ik Kyung Jang, Rob GersztenHarvard Public School of HealthScott Gazelle, Joseph Ladapo, Milton Weinstein