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      • Natural History of Diabetic Coronary Atherosclerosis by Quantitative Measurement of Serial Coronary Computed Tomographic Angiography : Results of the PARADIGM Study

        Kim, Ung,Leipsic, Jonathon A.,Sellers, Stephanie L.,Shao, Michael,Blanke, Philipp,Hadamitzky, Martin,Kim, Yong-Jin,Conte, Edoardo,Andreini, Daniele,Pontone, Gianluca,Budoff, Matthew J.,Gottlieb, Ilan Elsevier 2018 JACC CARDIOVASCULAR IMAGING Vol.11 No.10

        <P><B>Abstract</B></P> <P><B>Objectives</B></P> <P>This study aimed to determine the rate and extent of plaque progression (PP), changes in plaque features, and clinical predictors of PP in patients with diabetes mellitus (DM).</P> <P><B>Background</B></P> <P>The natural history of coronary PP in patients with DM is not well established.</P> <P><B>Methods</B></P> <P>A total of 1,602 patients (age 61.3 ± 9.0 years; 60.3% men; median scan interval 3.8 years) who underwent serial coronary computed tomography angiography over a period of at least 24 months were enrolled and analyzed from the PARADIGM (Progression of Atherosclerotic Plaque Determined by Computed Tomographic Angiography Imaging) trial. Study endpoints were changes in plaque features in diabetics with PP and risk factors for PP by serial coronary computed tomography angiography between patients with and without DM. PP was defined if plaque volume at follow-up minus plaque volume at baseline was >0.</P> <P><B>Results</B></P> <P>DM was an independent risk factor for PP (84.6%; 276 of 326 patients with PP) in multivariate analysis (odds ratio [OR]: 1.526; 95% confidence interval [CI]: 1.100 to 2.118; p = 0.011). Independent risk factors for PP in patients with DM were male sex (OR: 1.485; 95% CI: 1.003 to 2.199; p = 0.048) and mean plaque burden at baseline ≥75% (OR: 3.121; 95% CI: 1.701 to 5.725; p ≤0.001). After propensity matching, percent changes in overall plaque volume (30.3 ± 36.9% in patients without DM and 36.0 ± 29.7% in those with DM; p = 0.032) and necrotic core volume (−7.0 ± 35.8% in patients without DM and 21.5 ± 90.5% in those with DM; p = 0.007) were significantly greater in those with DM. The frequency of spotty calcification, positive remodeling, and burden of low-attenuation plaque were significantly greater in patients with DM.</P> <P><B>Conclusions</B></P> <P>People with DM experience greater PP, particularly significantly greater progression in adverse plaque, than those without DM. Male sex and mean plaque burden >75% at baseline were identified as independent risk factors for PP.</P> <P><B>Graphical abstract</B></P> <P>[DISPLAY OMISSION]</P>

      • Rationale and design of the Progression of AtheRosclerotic PlAque DetermIned by Computed TomoGraphic Angiography IMaging (PARADIGM) registry: A comprehensive exploration of plaque progression and its impact on clinical outcomes from a multicenter serial

        Lee, S.E.,Chang, H.J.,Rizvi, A.,Hadamitzky, M.,Kim, Y.J.,Conte, E.,Andreini, D.,Pontone, G.,Volpato, V.,Budoff, M.J.,Gottlieb, I.,Lee, B.K.,Chun, E.J.,Cademartiri, F.,Maffei, E.,Marques, H.,Leipsic, J C. V. Mosby Co 2016 American Heart Journal Vol.182 No.-

        <P>Background The natural history of coronary artery disease (CAD) in patients with low-to-intermediate risk is not well characterized. Although earlier invasive serial studies have documented the progression of atherosclerotic burden, most were focused on high-risk patients only. The PARADIGM registry is a large, prospective, multinational dynamic observational registry of patients undergoing serial coronary computed tomographic angiography (CCTA). The primary aim of PARADIGM is to characterize the natural history of CAD in relation to clinical and laboratory data. Design The PARADIGM registry (ClinicalTrials. gov NCT02803411) comprises >= 2,000 consecutive patients across 9 cluster sites in 7 countries. PARADIGM sites were chosen on the basis of adequate CCTA volume, site CCTA proficiency, local demographic characteristics, and medical facilities to ensure a broad-based sample of patients. Patients referred for clinically indicated CCTA will be followed up and enrolled if they had a second CCTA scan. Patients will also be followed up beyond serial CCTA performance to identify adverse CAD events that include cardiac and noncardiac death, myocardial infarction, unstable angina, target vessel revascularization, and CAD-related hospitalization. Summary The results derived from the PARADIGM registry are anticipated to add incremental insight into the changes in CCTA findings in accordance with the progression or regression of CAD that confer prognostic value beyond demographic and clinical characteristics.</P>

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