1.First-in-Human Evaluation of a Polymer-Free Everolimus-Eluting Stent Using a Titanium Dioxide Film
Doo Sun SIM ; Kyung Hoon CHO ; Dae Young HYUN ; Dae Sung PARK ; Jun-Kyu PARK ; Dae-Heung BYEON ; Won-Il JO ; Sang-Wook KIM ; Joon Ho AHN ; Seung Hun LEE ; Min Chul KIM ; Young Joon HONG ; Ju Han KIM ; Youngkeun AHN ; Myung Ho JEONG
Journal of Korean Medical Science 2024;39(33):e234-
Background:
In patients with coronary artery disease treated with permanent polymercoated drug-eluting stents (DES), the persistent presence of a less biocompatible polymer might delay arterial healing. Thin strut polymer-free DES have the potential to improve clinical outcomes and reduce the duration of dual antiplatelet therapy (DAPT). The purpose of this first-in-human study was to assess the safety and effectiveness of a novel polymer-free DES in patients with de novo coronary lesions. The TIGERevolutioN® stent (CG Bio Co., Ltd., Seoul, Korea) consists of a cobalt chromium platform with a strut thickness of 70 μm and a surface treated with titanium dioxide onto which everolimus-eluting stent (EES) is applied abluminally (6 µg/mm of stent length) without utilization of a polymer.
Methods:
A total of 20 patients were enrolled, with de novo coronary lesions (stable or unstable angina) and > 50% diameter stenosis in a vessel 2.25 to 4.00 mm in diameter and ≤ 40 mm in length for angiographic, optical coherence tomography (OCT), and clinical assessment at 8 months. All patients received DAPT after stent implantation. The primary endpoint was angiographic in-stent late lumen loss (LLL) at 8 months.
Results:
Twenty patients with 20 lesions were treated with TIGERevolutioN® . At 8 months, in-stent LLL was 0.7 ± 0.4 mm. On OCT, percent area stenosis was 29.2 ± 9.4% and stent strut coverage was complete in all lesions. No adverse cardiovascular event occurred at 8 months.
Conclusion
The new polymer-free EES was safe and effective with low LLL and excellent strut coverage at 8 months of follow-up.
2.Preliminary Investigation on Efficacy and Safety of Substance P-Coated Stent for Promoting Re-Endothelialization: A Porcine Coronary Artery Restenosis Model
Dae Sung PARK ; Seok OH ; Yu Jeong JIN ; Mi Hyang NA ; Munki KIM ; Jeong Ha KIM ; Dae Young HYUN ; Kyung Hoon CHO ; Young Joon HONG ; Ju Han KIM ; Youngkeun AHN ; Manuel HERMIDA-PRIETO ; José Manuel VÁZQUEZ-RODRIGUEZ ; Juan Luis GUTIÉRREZ- CHICO ; Luis MARINÃS-PARDO ; Kyung Seob LIM ; Jun-Kyu PARK ; Dae-Heung BYEON ; Young-Nan CHO ; Seung-Jung KEE ; Doo Sun SIM ; Myung Ho JEONG
Tissue Engineering and Regenerative Medicine 2024;21(1):53-64
BACKGROUND:
Current polymer-based drug-eluting stents (DESs) have fundamental issues about inflammation and delayed re-endothelializaton of the vessel wall. Substance-P (SP), which plays an important role in inflammation and endothelial cells, has not yet been applied to coronary stents. Therefore, this study compares poly lactic-co-glycolic acid (PLGA)-based everolimus-eluting stents (PLGA-EESs) versus 2-methacryloyloxyethyl phosphorylcholine (MPC)-based SP-eluting stents (MPC-SPs) in in-vitro and in-vivo models.
METHODS:
The morphology of the stent surface and peptide/drug release kinetics from stents were evaluated. The invitro proliferative effect of SP released from MPC-SP is evaluated using human umbilical vein endothelial cell. Finally, the safety and efficacy of the stent are evaluated after inserting it into a pig’s coronary artery.
RESULTS:
Similar to PLGA-EES, MPC-SP had a uniform surface morphology with very thin coating layer thickness (2.074 lm). MPC-SP showed sustained drug release of SP for over 2 weeks. Endothelial cell proliferation was significantly increased in groups treated with SP (n = 3) compared with the control (n = 3) and those with everolimus (n = 3) (SP:118.9 ± 7.61% vs. everolimus: 64.3 ± 12.37% vs. the control: 100 ± 6.64%, p < 0.05). In the animal study, the percent stenosis was higher in MPC-SP group (n = 7) compared to PLGA-EES group (n = 7) (MPC-SP: 28.6 ± 10.7% vs. PLGAEES: 16.7 ± 6.3%, p < 0.05). MPC-SP group showed, however, lower inflammation (MPC-SP: 0.3 ± 0.26 vs. PLGAEES: 1.2 ± 0.48, p < 0.05) and fibrin deposition (MPC-SP: 1.0 ± 0.73 vs. PLGA-EES: 1.5 ± 0.59, p < 0.05) around the stent strut. MPC-SP showed more increased expression of cluster of differentiation 31, suggesting enhanced reendothelialization.
CONCLUSION
Compared to PLGA-EES, MPC-SP demonstrated more decreased inflammation of the vascular wall and enhanced re-endothelialization and stent coverage. Hence, MPC-SP has the potential therapeutic benefits for the treatment of coronary artery disease by solving limitations of currently available DESs.
3.Prediction of Severity and Adverse Outcomes Associated with Perforation in Patients Presenting to the Emergency Department with Esophageal Injury
Eui Sun JEONG ; Hye-Kyung JUNG ; Ju Ran BYEON ; Ayoung LEE ; Ji Taek HONG ; Seong-Eun KIM ; Chang Mo MOON
The Korean Journal of Helicobacter and Upper Gastrointestinal Research 2023;23(1):42-51
Background/Aims:
Esophageal perforation is associated with high mortality and morbidity in patients presenting to the emergency department (ED) with esophageal injury. We investigated the effectiveness of initial CT scan in patients with esophageal injury to determine the risk factors for complications.
Methods:
Patients admitted through the ED for evaluation of esophageal injuries between January 2001 and May 2020, were investigated. Demographic data, etiological factors, comorbidities, treatment administered, and outcomes were collected. Esophageal injury was graded based on the following CT criteria: (a) normal, (b) pneumomediastinum, (c) mediastinitis, fluid collection, abscess, or overt esophageal wall injury, and (d) pleural effusion, subcutaneous emphysema, or pneumothorax. Grade 2 was defined as microperforation and grades 3 and 4 as overt perforation.
Results:
Of 281 patients with esophageal injury, 38 had CT-documented overt perforations and 20 had microperforations. Foreign body-induced injury (n=37), Boerhaave syndrome (n=12), and chemical injury (n=3) were common causes of esophageal injury. Complications occurred in 24 (8.5%) patients. Risk factors for complications were age ≥65 years (OR 4.14, 95% CI 1.18~14.56, P=0.027), cerebrovascular disease (OR 8.58, 95% CI 1.13~65.19, P=0.038), Boerhaave syndrome (OR 12.52, 95% CI 2.07~75.68, P=0.006), chemical injury (OR 15.72, 95% CI 3.67~67.28, P<0.001), and CT-documented grade 4 perforation (OR 15.75, 95% CI 4.39~56.55, P<0.001).
Conclusions
Initial CT-based grading in the ED are useful for predicting potential complications and for managing patients with esophageal injury and suspected perforation.
4.The Relationship Between Zonulin and Asthma: A Mouse Model Study
Joon-Pyo HONG ; Sung Hun KANG ; Jinah CHU ; Sun-Ju BYEON ; Hyunjoo LEE ; Jeong-Hee CHOI ; Kyung Chul LEE ; Seok Jin HONG
Journal of Rhinology 2023;30(3):161-166
Background and Objectives:
Zonulin is a human protein that regulates intercellular tight junctions and increases the permeability of the intestinal epithelium. In light of the increasing focus on zonulin’s role in numerous chronic inflammatory diseases, this study aimed to investigate whether differences exist in serum zonulin levels and bronchial epithelium zonulin expression in vivo between asthma and normal groups, using a mouse model.
Methods:
Sixteen mice were utilized in this study, divided evenly between the normal and asthma groups. Serum zonulin levels, the expression of zonulin antibody in the bronchial epithelium, and serum cytokine levels were evaluated in both groups. Enzyme-linked immunosorbent assay and RNA in situ hybridization were utilized for the analysis.
Results:
The asthma group exhibited significantly higher levels of serum zonulin. High zonulin antibody expression was also observed in the bronchial epithelium of the asthma group. Given that our mouse model demonstrated a significant difference in interleukin (IL)-4 and IL-6 between the normal and asthma groups, zonulin may be associated not only with type 2 responses but also with various subtypes of asthma. Further studies are required to investigate this relationship in greater detail.
Conclusion
Zonulin may play a role in the complex pathophysiology of asthma and could serve as a biomarker in various asthma-related situations.
5.Analysis of Adverse Drug Reactions to First-Line Anti-Tuberculosis Drugs Using the Korea Adverse Event Reporting System
Soo Jie CHUNG ; Sun-ju BYEON ; Jeong-Hee CHOI
Journal of Korean Medical Science 2022;37(16):e128-
Background:
Adverse drug reactions (ADRs) to first-line anti-tuberculosis (TB) drugs are common; however, there have been few reports of nationwide epidemiologic studies on ADRs to anti-TB drugs in Korea. This study aimed to investigate the clinical characteristics of various ADRs to first-line anti-TB drugs using a nationwide database of ADRs.
Methods:
We used the Korea Adverse Event Reporting System (KAERS) database (2009– 2018). The study subjects were selected using the Korean Standard Classification of Diseases codes for pulmonary and extrapulmonary TB and electronic data interchange codes for isoniazid (INH), rifampicin (RIF), ethambutol (ETB), and pyrazinamide (PZA). The causality assessment of “possible,” “probable,” or “certain” by World Health Organization-Uppsala Monitoring Center System causality category was selected.
Results:
A total of 1,562,024 ADRs were reported in the KIDS-KAERS database from 2009 to 2018, where ADRs to first-line anti-TB drugs were 17,843 cases (1.14%). The most common causative drugs were RIF (28.7%), INH (24.0%), ETB (23.4%), and PZA (23.9%) in that order. 48.5% of cases were reported in the older patients (≥ 60 years). According to organ system, gastro-intestinal system disorder was most common (32.0%), followed by skin and appendage (25.9%), liver and biliary system (14.2%). Nausea was the most common ADR (14.6%), followed by hepatic enzyme elevation (14.2%), rash (11.7%), pruritus (9.1%), vomiting (8.9%), and urticaria (4.2%). Most ADRs appeared within 1 month, but ADRs such as neuropathy, paresthesia, hematologic abnormalities, renal function abnormalities and liver enzyme abnormality were also often reported after 2 months.
Conclusion
Our data are clinically informative for recognizing and coping with ADRs of antiTB drugs.
6.Clinical outcomes of acute upper gastrointestinal bleeding according to the risk indicated by Glasgow-Blatchford risk score-computed tomography score in the emergency room
Hyun Ae LEE ; Hye-Kyung JUNG ; Tae Oh KIM ; Ju-Ran BYEON ; Eui-Sun JEONG ; Hyun-Ji CHO ; Chung Hyun TAE ; Chang Mo MOON ; Seong-Eun KIM ; Ki-Nam SHIM ; Sung-Ae JUNG
The Korean Journal of Internal Medicine 2022;37(6):1176-1185
Background/Aims:
Acute upper gastrointestinal (UGI) bleeding is a significant emergency situation with a mortality rate of 2% to 10%. Therefore, initial risk stratification is important for proper management. We aimed to evaluate the role of contrast-enhanced multidetector computed tomography (MDCT) for risk stratification in patients with acute UGI bleeding in the emergency room (ER).
Methods:
This retrospective study included patients with UGI bleeding in the ER. Glasgow-Blatchford risk score-computed tomography (GBS-CT) was assessed using a combination of GBS and the MDCT scan scoring system.
Results:
Of the 297 patients with UGI bleeding, 124 (41.8%) underwent abdominal MDCT. Among them, 90.3% were classified as high-risk by GBS, and five patients died (4.0%). Rebleeding occurred in nine patients (7.3%). The high-risk GBS-CT group had significantly higher in-hospital mortality (10.5% in high-risk vs. 1.4% in moderate risk vs. 0% in low-risk, p = 0.049), transfusion amount (p < 0.001), and endoscopic hemostasis (p < 0.001) compared to the moderate- and low-risk groups.
Conclusions
Adding MDCT scans to the existing validated prognosis model when predicting the risk of UGI bleeding in patients in the ER plays a significant role in determining in-hospital mortality, transfusions, and the need for endoscopic hemostasis.
7.Sodium-Glucose Cotransporter-2 Inhibitor-Related Diabetic Ketoacidosis: Accuracy Verification of Operational Definition
Dong Yoon KANG ; Hyunah KIM ; SooJeong KO ; HyungMin KIM ; Jiwon SHINN ; Min-Gyu KANG ; Sun-ju BYEON ; Jeong-Hee CHOI ; Soo-Yong SHIN ; Hun-Sung KIM
Journal of Korean Medical Science 2022;37(7):e53-
Background:
The most important aspect of a retrospective cohort study is the operational definition (OP) of the disease. We developed a detailed OP for the detection of sodiumglucose cotransporter-2 inhibitors (SGLT2i) related to diabetic ketoacidosis (DKA). The OP was systemically verified and analyzed.
Methods:
All patients prescribed SGLT2i at four university hospitals were enrolled in this experiment. A DKA diagnostic algorithm was created and distributed to each hospital;subsequently, the number of SGLT2i-related DKAs was confirmed. Then, the algorithm functionality was verified through manual chart reviews by an endocrinologist using the same OP.
Results:
A total of 8,958 patients were initially prescribed SGLT2i. According to the algorithm, 0.18% (16/8,958) were confirmed to have SGLT2i-related DKA. However, based on manual chart reviews of these 16 cases, there was only one case of SGLT2i-related DKA (positive predictive value = 6.3%). Even after repeatedly narrowing the diagnosis range of the algorithm, the effect of a positive predictive value was insignificant (6.3–10.0%, P > 0.999).
Conclusion
Owing to the nature of electronic medical record data, we could not create an algorithm that clearly differentiates SGLT2i-related DKA despite repeated attempts. In all retrospective studies, a portion of the samples should be randomly selected to confirm the accuracy of the OP through chart review. In retrospective cohort studies in which chart review is not possible, it will be difficult to guarantee the reliability of the results.
9.Pulmonary Adenofibroma Manifesting as Two Nodules in Different Lobes of the Lung: A Case Report
Minsu KIM ; Young-A BAE ; Sun-Ju BYEON ; Jung-Ah CHOI
Journal of the Korean Radiological Society 2020;81(2):436-441
Pulmonary adenofibroma is a rare tumor, with a few reported cases in the literature. Radiologically, the lesion appears as a solitary pulmonary nodule in most cases, and the multiplicity of this disease entity is extremely rare. We present an unusual case of pulmonary adenofibroma in a 71-year-old woman manifested as two nodules in different lobes of the lung on CT. Histopathological and immunohistochemical examinations are needed to establish the definitive diagnosis of pulmonary adenofibroma.
10.Pulmonary Adenofibroma Manifesting as Two Nodules in Different Lobes of the Lung: A Case Report
Minsu KIM ; Young-A BAE ; Sun-Ju BYEON ; Jung-Ah CHOI
Journal of the Korean Radiological Society 2020;81(2):436-441
Pulmonary adenofibroma is a rare tumor, with a few reported cases in the literature. Radiologically, the lesion appears as a solitary pulmonary nodule in most cases, and the multiplicity of this disease entity is extremely rare. We present an unusual case of pulmonary adenofibroma in a 71-year-old woman manifested as two nodules in different lobes of the lung on CT. Histopathological and immunohistochemical examinations are needed to establish the definitive diagnosis of pulmonary adenofibroma.

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