Multidetector CT Angiography for the Detection of Left Main Coronary Artery Disease. Rani K. Hasan, M.D. Intro to Clinical Research July 22 nd, 2011

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1 Multidetector CT Angiography for the Detection of Left Main Coronary Artery Disease Rani K. Hasan, M.D. Intro to Clinical Research July 22 nd, 2011

2 Outline Background Hypothesis Study Population Methodology Significance

3 Background Multidetector CT angiography (MDCTA) has established accuracy in the diagnosis of coronary artery disease. Two recent prospective multicenter trials have shown that MDCTA compares favorably to invasive angiography (reference standard). MDCTA compares favorably to invasive angiography (ICA)with regards to cost and safety. Cost: ~$500 for MCDTA vs ~$3000 for ICA Radiation: 3-15 msv for MDCTA vs 2-20 msv for ICA The use of MDCTA is increasing for non-invasive evaluation of suspected coronary artery. AJR Am J Roentgenol 2010;194: Circulation 2007;116:

4 MDCTA versus Invasive Coronary Angiography (ICA) MDCTA Spatial resolution ~0.5 mm Temporal resolution ~ ms Vessel wall and lumen Reference diameters Plaque morphology 3-D reconstruction allows visualization in numerous planes No vessel overlap or foreshortening artifacts ICA Spatial resolution ~0.2 mm Temporal resolution ~5-10 ms Lumenography Limited image planes Dependent on views taken, increase contrast and radiation with more views Vessel overlap, foreshortening artifacts Real-time imaging

5 Diagnostic Accuracy of Cardiac MDCTA in Symptomatic Patients Mean Sensitivity Mean Specificity Area Under the Curve Positive Likelihood Ratio Negative Likelihood Ratio All Studies (89) 97.2 ( ) 87.4 ( ) 0.98 ( ) 7.7 ( ) 0.03 ( ) Scanner Rows > ( ) 89.4 ( ) ( ) 84.7 ( ) Heart Rate < 60 bpm 99.0 ( ) 85.8 ( ) > 60 bpm 96.2 ( ) 87.7 ( ) Schuetz GM et al. Ann Intern Med. 2010;152(3):

6 Background Left main coronary artery disease has been recognized as the highest risk form of CAD, with an observed three-year mortality of up to 37% without revascularization. Coronary artery bypass surgery is the current standard treatment for left main coronary artery disease, but use of percutaneous coronary intervention is increasing. Accurate detection and morphologic characterization of left main coronary disease is paramount in selection of the appropriate revascularization strategy. ICA is the current standard MDCTA may provide a non-invasive alternative to ICA and obviate need for cardiac catheterization in patients in whom surgery is more appropriate

7 Hypothesis MDCTA can accurately detect left main coronary artery disease and characterize important morphologic characteristics of left main lesions compared to ICA.

8 Study Population STUDY DESIGN: Secondary data analysis of two completed prospective multicenter trials that assessed the diagnostic accuracy of MDCTA compared to ICA for the diagnosis of obstructive coronary disease. INCLUSION CRITERIA: Adults 40 years of age Chest pain and suspected coronary artery disease referred for ICA. Left main coronary artery disease defined as 50% luminal stenosis by quantitative coronary angiography.

9 Methods EXCLUSION CRITERIA: Contraindication to iodinated contrast dye Atrial fibrillation or other arrhythmia Evidence of severe symptomatic HF Moderate or severe aortic stenosis Previous cardiac surgery Percutaneous coronary intervention within 6 months Intolerance or contraindication to beta-blockers Morbid obesity Inadequate CT images

10 Methods 850 patients with suspected CAD MDCTA 20 patients with inadequate CT images ICA (within 30 days) 680 patients without left main disease 150 patients in analysis

11 Methods MDCTA Core Lab ICA Core Lab Statistical analysis Blinded image analysis by 2 independent reviewers for each imaging modality Standardized imaging and analysis protocols Adjudication process to ensure cross-modality correspondence

12 Methods Outcome Analysis Primary Obstructive left main disease Sensitivity, specificity Secondary Left main calcification Sensitivity, specificity Left main bifurcation Left main bifurcation type Radiation dose Contrast dose Adverse event rate Sensitivity, specificity Sensitivity, specificity Mann-Whitney U test Mann-Whitney U test Fisher s exact test

13 Significance MDCTA is growing as a non-invasive means of diagnosing coronary artery disease. Left main coronary artery disease portends a poor prognosis without revascularization, and ICA is the current standard for diagnosis and selection of a revascularization strategy. Non-invasive detection and characterization of left main lesions may enable selection of a revascularization strategy without the need for diagnostic cardiac catheterization. Avoid an additional and costly invasive study for patients who will require surgery without compromising safety Compared to earlier studies, this analysis will have the advantage of building on pre-existing robust study design including standardized imaging protocols and blinded evaluation of imaging findings by centralized laboratories.

14 Acknowledgements Mentor: Julie Miller Small Group Members: Jeanne Clark Nisa Maruthur Martha Zeiger Sharon Ahluwalia Dara Neuman-Sunshine Angela Wabulya Amy Rushing

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