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Results of ED Coronary CTA Trials Udo Hoffmann, MD MPH.

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Presentation on theme: "Results of ED Coronary CTA Trials Udo Hoffmann, MD MPH."— Presentation transcript:

1 Results of ED Coronary CTA Trials Udo Hoffmann, MD MPH

2 Research Grants: Bracco Diagnostics Bayer Healthcare GE Healthcare Disclosures

3 Anderson JL et al.Circulation. 2007;116:e148-304.

4 CT is especially suited for the ED setting - ECG, initial biomarkers, and clinical presentation and traditional risk factors – no safe triage possible (Nagurney, JAMA 2006) - goal in the ED: quick turnover and identification who do NOT need to be admitted - only 20% of patients with ACP have ACS, 80% could be discharged - requires a fast, available and robust diagnostic imaging test with nearly perfect NPV - CAD – No. 1 cause for ACS (80%-90%) – optimally direct visualization

5 Coronary Calcium in ACP Patients with uncertain MI and no history of CAD Reference Mod N Sens Spec PPV NPV Laudon et al. Ann Em Med 1999EBCT1051.00N/AN/A1.00 McLaughlin et al. Am J Cardi 1999EBCT1340.880.370.080.98 Georgiou et al. JACC 2001 1999EBCT1921.000.470.261.00 ??% of patients have only non-calcified plaque

6 Important ED coronary CTA studies Hollander et al. 568 patients, none of the discharged subjects (n=476, 84%) who all had absence of significant stenosis (>50%) suffered a cardiovascular event (cardiovascular death, non-fatal myocardial infarction) during a 30-day follow-up period

7 ROMICAT I – Demographics and Risk Factors Age (years, mean  SD) 52.7±12 Male Gender (n, %)223 (61%) Race (n, %) African American Caucasian Asians Others 31 (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/ 0.3 ACS during index hospitalization (%, n) Unstable angina pectoris (%, n) Myocardial infarction (%, n) 31 (8%) 23 (74%) 8 (26%) MACE during six month follow- up (%, n): Recurrent chest pain: Outpatient evaluation (PCP) Readmission without testing Readmission with testing 0 68 (18%) 50 (74%) 5 (7%) 13 (19%) Hoffmann et al. JACC 2009

8 Prevalence of Plaque and Stenosis in ACP No CAD 50.4% Significant stenosis detected/ not excluded 18.4% Non-obstructive Plaque 31.2% CAD categories by CT with relevance for early triage of patients with ACP in the ED (n=368, 8% ACS) Hoffmann et al. JACC 2009

9 ROMICAT I – CAD and ACS No CAD No ACS Hoffmann et al. JACC 2009

10 ROMICAT I – CAD and ACS No CAD Nonobstructive Plaque No ACS 7 ACS non-stenotic ACS small vessel disease Hoffmann et al. JACC 2009

11 Challenges – small coronary branches 59-year old female with typical chest pain, non- diagnostic ECG and negative serial Troponin

12 ROMICAT I – CAD and ACS No CAD Nonobstructive Plaque Significant stenosis detected or not excluded No ACS 7 ACS non-stenotic ACS small vessel disease 24 ACS Hoffmann et al. JACC 2009

13 ROMICAT I – Diagnostic Accuracy Sens: 100% (0.88-1.00) NPV: 100% (0.98-1.00) Spec: 54% (0.49-0.60) PPV: 17% (0.12-0.23) ACS No ACS Plaque No Plaque 31154 0183 Sens: 77% (0.59-0.90) NPV: 98% (0.95-0.99) Spec: 87% (0.82-0.90) PPV: 35% (0.24-0.48) ACS No ACS Sign. Stenosis No Stenosis 2444 7293 1. Triage Criterion: Presence of Plaque 2. Triage Criterion: Presence of Stenosis (>50%) Hoffmann et al. JACC 2009

14 Efficacy of CT - Age and Gender Age Pre Prob Risk Prob - neg. Test Risk Prob - pos. Test Risk Women <450% Very low ---- 45-552%Low0% (2%)Very low18% (16%)High 55-654%Low0% (4%)Very low27% (23%)High >6521%High13% (8%)Intermed38% (17%)High Men <455%Low0% (5%)Very low57% (51%)High 45-554%Low1% (3%)Very low22% (18%)High 55-6523%High12% (11%)Intermed46% (23%)High >6528%High12% (16%)Intermed35% (7%) Interme d Bamberg et al. AJC 2009

15 What to do with stenotic lesions? severe RCA lesion

16 Hoffmann JACC 2006, Motoyama JACC 2007, Kitagawa AHJ 2008 Non-calcified plaque Positive remodeling Spotty calcification Culprit Lesions Features

17 A CT-based Score to Identify Culprit Coronary Lesions Among Patients With Acute Chest Pain and Low to Intermediate Likelihood of ACS Maros Ferencik, Christopher L. Schlett, Khuram A. Nasir, Brian B. Ghoshhajra, Mathias F. Kriegel, Subodh B. Joshi, Ian S. Rogers, Quynh A. Truong, Dahlia Banerji, Fabian Bamberg, Thomas J. Brady, John T. Nagurney, Udo Hoffmann Cardiology Division, Dept. of Radiology and Dept. of Emergency Medicine Cardiac MR PET CT Program Massachusetts General Hospital and Harvard Medical School

18 Background Retrospective studies suggest that lesion culprit lesions in ACS patients can be identified by CT and are characterized by –Positive remodeling index –Spotty calcifications –Larger plaque areas –Low CT attenuation of the plaque However, whether these criteria enable appropriate risk stratification among patients who have significant stenosis is unknown Motoyama S et al. JACC. 2009;54:49 Motoyama S et al. JACC. 2007;50:319 Hoffmann U et al. JACC. 2006;47:1655

19 Methods – Subject Selection CT performed in 368 subjects with acute chest pain but without objective evidence of ACS In 34/368 subjects (9%) at least one >50% stenosis was detected by CT –21 subjects with ACS –13 subjects without ACS culprit vessels/lesions were determined based on combination of available clinical data (nuclear stress test, invasive coronary angiography)

20 Methods – Characterization of stenotic lesions by Coronary CTA CT images were analyzed on a dedicated workstation (Vitrea, Vital Images) Two independent readers analyzed the data, blinded to the clinical information Measurements –Degree of stenosis –Stenosis length –Remodeling index –Plaque area at the site of the stenosis –Plaque volume Plaque composition: non-calcified, spotty calcifications, heavy calcification

21 Results – Subject Characteristics ACS (n=21) No ACS (n=13) p- value Age (years)61 (51-67)58 (49-65)0.97 Gender (male)18 (86%)11 (85%)1.00 BMI27 (25-30)31 (28-33)0.05 HTN14 (67%)11 (85%)0.43 HLP11 (52%)8 (62%)0.73 Diabetes3 (14%)6 (46%)0.06

22 Results - Coronary Plaque Characteristics ACS (n=21) No ACS (n=13) P Degree of Stenosis (%)73 (65-83)66 (56-85)0.64 Length of Stenosis (mm)5 (4-8)4 (3-5)0.02 Positive Remodeling (RI >1.05) 13 (62%)2 (15%)0.01 Plaque Length (mm)15 (11-22)14 (12-19)0.67 Plaque Area (mm 2 )14 (11-17)10 (7-18)0.11 Plaque Volume (mm 3 )212 (126-264)171 (78-223)0.24 <90 HU Plaque Volume (mm 3 ) 91 (51-109)49 (40-75)0.03 Spotty Calcification10 (48%)2 (15% )0.08

23 Results – CT-based Score and Prediction of ACS Score AScore BScore CScore D Spotty CalcificationXXXX Positive RemodelingXXXX Length of Stenosis (>4.5 mm) XXX 80 mm 3 ) XX Plaque Area (>10 mm 2 )X OR for predicting ACS4.15.44.03.7 (95% CI)(1.3- 12.8) (1.8- 16.3) (1.6- 10.2) (1.5-8.8) p-value0.010.0030.004 AUC0.760.850.860.88

24 Results – ROC Analysis Score D Cutoff = 2 Sens 90% Spec 85% PPV90% NPV85%

25 Limitations Small sample size Invasive coronary angiography not available for all subjects IVUS not available for the verification of plaque characteristics Findings need further validation in a larger sample

26 Conclusions Confirmed earlier studies that culprit lesions in ACS are characterized by –positive remodeling, spotty calcifications, larger plaque areas, and low CT attenuation of the plaque Identified length of stenosis as additional characteristics Demonstrate high accuracy of a CT-based score for ACS within the subgroup of patients with significant stenosis on coronary CTA May serve as a triage criterion to decide whether patients with significant stenosis but absence of objective signs of ischemia should be referred to invasive coronary angiography

27 What to do with stenotic lesions? severe RCA lesion

28 14/34 patients with a significant stenosis in CT had no ACS or MACE after 6 months Stenosis w/o ACS

29 Incremental Value of LV function severe RCA lesion no regional LV dysfunction normal stress SPECT study Discharge diagnosis of ‘non cardiac chest pain’ No MACE after 6 months

30 Incremental value of LV Function SensitivitySpecificityPPVNPV Subjects with non-obstructive plaque (n=112) Regional LV dysfunction 3/7 43% (17 – 73) 97/105 92% (90 – 94) 3/11 27% (11 - 46) 97/101 96% (94 - 98) Subjects with non-diagnostic CT scan (n=32) Regional LV dysfunction 3/5 60% (25 - 87) 23/27 85% (79 – 90) 3/7 43% (18 – 62) 23/25 92% (85 - 97) Subjects with significant stenosis (n=32) Regional LV dysfunction 15/18 83% (69 – 91) 12/14 86% (67 – 95) 15/17 88% (73 – 96) 12/15 80% (63 – 88) Seneviratne et al. submitted

31 - cardiac CT vs. nuclear stress perfusion imaging in patients at very low risk for ACS (serial negative Troponin measurements) - Outcomes: ACS during index hospitalization and 6 month FU

32 Gold Standard UAP More Interventions in very low risk population Outcomes

33 Time to Diagnosis and LOS Shorten LOS and minimize cost

34 presumptive diagnosis and management after standard ED triage with cardiology consultation (n=58) CCTA was performed and results presented to caregivers who adjusted their recommendations –revised ACS diagnosis in 18 of 41 patients –canceled hospitalizations in 21 of 47 –altered early invasive treatment in 25 of 58 no MACE events were recorded in the 32 patients discharged from the ED Cardiac CT- Changing Management Rubinshtein Circulation 2007

35 CT will be highly effective because.. 1. Fast, robust, and available – unique direct visualization of CAD 2. Strength of CT – high NPV - high Prevalence of negative CT exams (50%) in patients in whom traditional risk assessment does not allow triage 3. Combined assessment of CAD and regional LVF - Incremental Value of LV function to guide management if CT is positive (modest PPV of CAD findings) 4. Prognostic benefits – warranty period, preventive therapy

36 Questions 1.Absence of CAD justifies discharge without serial Troponin? 2.Incremental benefit of LV function justifies additional radiation exposure? 3.CT appropriate for very low, low or intermediate risk ED patients? 4.CT saves invasive angiograms – i.e. in patients with minimal troponin increase (exclusion of significant CAD in myocarditis) 5.Change of CT indication by introduction of hs troponin 6.TRO

37 Additional Promises of CT - Prognostic Benefits 1. negative CT – “clean bill” for several years - decrease of subsequent testing in repeated presenters 2. CT - new non-obstructive disease – initiation of secondary prevention

38 Lehman et al. American Journal of Medicine 2009 Incidental findings by CT

39 Definite alternative diagnosis: 1.3% pneumonia (n=3), pneumothorax (n=1), and gallstones in a patient with cholecystitis (n 1). Possible alternative diagnosis: 4.1% No PE, AD hiatus hernia (n=12), thoracic aortic aneurysm (n=3), sinus of Valsalva aneurysm (n=1) Subsequent diagnostic testing in 20.5% of patients, with 65/81 for noncalcified nodules Within 6 months, 3 patients underwent biopsies with 2 of the lesions diagnosed as cancer. Lehman et al. American Journal of Medicine 2009 ROMICAT I – Incidental Findings by CT

40 - CT STAT (16 centers, 700 patients, PI Gil Raff) - CT vs. MPI in low risk patients - sponsor: Bayer Healthcare - ACRIN (4 centers, 1300 patients, PI Harold Litt) - CT vs. SOC in low risk patients - sponsor: ACRIN - ROMICAT II (7 centers, 1000 patients, PI Udo Hoffmann) - CT vs. SOC in intermediate risk patients - sponsor: NHLBI Outcomes: low health effect size, cost driven, potentially MACE over two years in intermediate risk Randomized Trials

41 James Goldstein, M.D., Kavitha Chinnaiyan, M.D., Daniel Berman, M.D., Udo Hoffmann, M.D., Stephan Achenbach, M.D., Leslee Shaw, Ph.D., Aiden Abidov, M.D., Ph.D., Brian O'Neill, M.D., John Lesser, M.D., Issam Mikati, M.D., Uma Valeti, M.D., Michael Shen, M.D., and Gilbert Raff, M.D., for the CT-STAT investigators CT –STAT Multi-center Prospective Randomized design 15 sites experienced with CCTA 750 “Low-risk” acute CP patients (TIMI Risk score<4, Initial ECG & Enzymes Normal)

42 CT STAT - OBJECTIVES Primary outcome: Diagnostic efficiency - Time-to-diagnosis & cost-to-diagnosis Secondary outcome: Safety - MACE over 6-months

43 CLINICAL DECISION ALGORITHM CCTA Arm Stenoses 0-25%  D/C Stenoses >70%  ICA Stenosis 26-70%, CAC >100 Agatston units, or uninterp scans  MPI SOC ARM Nl serial ECGs cardiac biomarkers and MPI  D/C Abnormal ECG, biomarkers and/or MPI  ICA

44 CLINICAL OUTCOMES: CCTA No stenosis 297/361 (82.3%) pts significant stenosis in 27 (7.5%) pts Moderate stenosis in 23 (7%) pts CTA uninterpretable in 14 (3.9%) pts MPI in 37 patients ICA in 24, revasc in 13 (9 PCI, 4 CABG) No ACS in patients in whom CCTA excluded stenoses

45 CLINICAL OUTCOMES: SOC CCTA in 8 patients ICA in 21 patients (8 PCI, no CABG)

46 CLINICAL OUTCOMES: CCTA vs SOC ICA during index visit (CCTA = 5.1%, SOC = 4.6%, p = NS). ACS (CCTA = 3.2%, SOC = 3%, p = NS).

47 TIME-TO-DIAGNOSIS CCTA Reduced Time by 54%, p=0.0001

48 COSTS-TO-DIAGNOSIS CCTA Reduced Costs by 38%, p=0.0001

49 CONCLUSIONS Low risk population – 3% ACS, 86% without significant CAD Time-to-diagnosis decreased by half, due to more rapid facilitation in testing Cost-to-diagnosis decreased by one-third, primarily due to expedited time-to- diagnosis and reduced length of stay

50 50 Overview of ROMICAT II Randomized controlled diagnostic multi center (n=7) trial, including 1000 subjects with acute chest pain and low to intermediate likelihood of ACS Primary Aim: To demonstrate that including cardiac CT into the early assessment of patients with ACP improves the efficiency of patient management.

51 51 Study Design * Defined as chest pain suspicious for ACS + inconclusive ECG. ** Hospital Length of Stay in discharged subjects is equal to time spent in the ED.

52 52 Study Organization

53 53 Timeline 09/09-01/10 Pre-enrollment period 01/10-05/11 Enrollment period 06/11-01/12 Follow-up and final database 02/12-12/12 Data analysis 01/13-09/13 Cost and cost effectiveness

54 Ancillary Studies Funded by ACRIN serial hs- troponin measurements – correlation with diagnostic testing and clinical outcomes* One and two year phone call follow- up to determine occurrence of MACE and health care utilization 54 *As part of the site survey, biomarker storage and handling capability information will be collected.

55 PROMISE

56

57 Cardiac CT researched in very low to low risk patient populations Benefits through high sensitivity but adverse effects in patients who may not need CT not sufficiently clarified Major change of ED setup and organization necessary to use CT optimally Conclusions

58 Thank you! MGH Cardiac MR PET CT Program Fabian Moselewski, Ian Rogers, Quynh Truong, Michael Shapiro, Sujith Seneviratne, John Nichols, Christopher Schlett, Sam Lehman, Maros Ferencik, Suhny Abbara, Ricardo C. Cury, Thomas J. Brady, Javed Butler, Nina Dannemann, Ron Blankstein, Khuram Nasir Department of Emergency Medicine John T. Nagurney, David F.M. Brown, Blair Parry Cardiology Division Claudia U. Chae, Ik Kyung Jang, Rob Gerszten Harvard Public School of Health Scott Gazelle, Joseph Ladapo, Milton Weinstein


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