Background Subclinical hypothyroidism (SCH) has recently been acknowledged as an unconventional risk factor for coronary artery disease (CAD) and characterized by poor prognosis, which may be due to atheroscleroti...Background Subclinical hypothyroidism (SCH) has recently been acknowledged as an unconventional risk factor for coronary artery disease (CAD) and characterized by poor prognosis, which may be due to atherosclerotic plaque characteristics. We conducted this study to observe coronary plaque characteristics in coronary artery disease patients with concomitant SCH. Methods Patients with coronary artery disease were enrolled in the study and divided into an SCH group (patients, n = 26; plaques, n = 35) and a non-SCH group (patients, n = 52; plaques, n = 66). They were divided 1:2 according to propensity-matched analysis including age, diabetes mellitus, gender, CAD severity and culprit vessel. Optical coherence tomography (OCT) imaging was performed on all patients, and images were analyzed by two inde- pendent investigators. Lipid-rich plaques (LRP), the precursor of vulnerable plaques, were defined as having more than one quadrant occu- pied with lipid pool. Maximum lipid arcs were simultaneously recorded. Fibrotic plaques and calcific plaques were also identified. The pres- ence of coronary dissection, plaque erosion, thrombus, macrophage, calcific nodule, thin-cap fibroatheroma and micro channel were all noted. Results The ratio of LRP in SCH group was significantly higher than that in non-SCH group (54% vs. 30.3%, P = 0.037). That was the case as well for the maximum lipid arcs value (181.5°± 61.6° vs. 142.1° 4± 35.9°, p = 0.046). While thin-cap fibroatheroma (TCFA) was detected, no difference was identified between the two groups in either TCFA ratio (20% vs. 16.7%, P = 0.579) or fibrous cap thickness (57.5 4± 14.0 vs. 63.5 4±10.7 gin, P = 0.319). Other OCT characteristics such as dissection, plaque erosion, thrombus, macrophage shadow and calcific nodule were also similar. ConcLusion Higher ratio of LRP with greater lipid arc in SCH patients may be related to the plaque instability and poor prognosis in CAD patients with SCH.展开更多
In this paper, for time-to-event data, we propose a new statistical framework for casual inference in evaluating clinical utility of predictive biomarkers and in selecting an optimal treatment for a particular patient...In this paper, for time-to-event data, we propose a new statistical framework for casual inference in evaluating clinical utility of predictive biomarkers and in selecting an optimal treatment for a particular patient. This new casual framework is based on a new concept, called Biomarker Adjusted Treatment Effect (BATE) curve. The BATE curve can be used for assessing clinical utility of a predictive biomarker, for designing a subsequent confirmation trial, and for guiding clinical practice. We then propose semi-p^rametric methods for estimating the BATE curves of biomarkers and establish asymptotic results of the proposed estimators for the BATE curves. We also conduct extensive simulation studies to evaluate finite-sample properties of the proposed estimation methods. Finally, we illustrate the application of the proposed method in a real-world data set.展开更多
文摘Background Subclinical hypothyroidism (SCH) has recently been acknowledged as an unconventional risk factor for coronary artery disease (CAD) and characterized by poor prognosis, which may be due to atherosclerotic plaque characteristics. We conducted this study to observe coronary plaque characteristics in coronary artery disease patients with concomitant SCH. Methods Patients with coronary artery disease were enrolled in the study and divided into an SCH group (patients, n = 26; plaques, n = 35) and a non-SCH group (patients, n = 52; plaques, n = 66). They were divided 1:2 according to propensity-matched analysis including age, diabetes mellitus, gender, CAD severity and culprit vessel. Optical coherence tomography (OCT) imaging was performed on all patients, and images were analyzed by two inde- pendent investigators. Lipid-rich plaques (LRP), the precursor of vulnerable plaques, were defined as having more than one quadrant occu- pied with lipid pool. Maximum lipid arcs were simultaneously recorded. Fibrotic plaques and calcific plaques were also identified. The pres- ence of coronary dissection, plaque erosion, thrombus, macrophage, calcific nodule, thin-cap fibroatheroma and micro channel were all noted. Results The ratio of LRP in SCH group was significantly higher than that in non-SCH group (54% vs. 30.3%, P = 0.037). That was the case as well for the maximum lipid arcs value (181.5°± 61.6° vs. 142.1° 4± 35.9°, p = 0.046). While thin-cap fibroatheroma (TCFA) was detected, no difference was identified between the two groups in either TCFA ratio (20% vs. 16.7%, P = 0.579) or fibrous cap thickness (57.5 4± 14.0 vs. 63.5 4±10.7 gin, P = 0.319). Other OCT characteristics such as dissection, plaque erosion, thrombus, macrophage shadow and calcific nodule were also similar. ConcLusion Higher ratio of LRP with greater lipid arc in SCH patients may be related to the plaque instability and poor prognosis in CAD patients with SCH.
基金supported by a Core Investigator,Research Career Scientist(Grant No.RCS OS-196)Biostatistics Unit Director at the Northwest HSR&D Center of Excellence,Department of Veterans Affairs Medical Center,Seattle,WA and Department of Veterans Affairs,Veterans Health Administration,Health Services Research and Development Service,project(Grant No.XVA61-036)
文摘In this paper, for time-to-event data, we propose a new statistical framework for casual inference in evaluating clinical utility of predictive biomarkers and in selecting an optimal treatment for a particular patient. This new casual framework is based on a new concept, called Biomarker Adjusted Treatment Effect (BATE) curve. The BATE curve can be used for assessing clinical utility of a predictive biomarker, for designing a subsequent confirmation trial, and for guiding clinical practice. We then propose semi-p^rametric methods for estimating the BATE curves of biomarkers and establish asymptotic results of the proposed estimators for the BATE curves. We also conduct extensive simulation studies to evaluate finite-sample properties of the proposed estimation methods. Finally, we illustrate the application of the proposed method in a real-world data set.