1.Efficacy and safety of sofosbuvir–velpatasvir and sofosbuvir–velpatasvir–voxilaprevir for hepatitis C in Korea: a Phase 3b study
Jeong HEO ; Yoon Jun KIM ; Sung Wook LEE ; Youn-Jae LEE ; Ki Tae YOON ; Kwan Soo BYUN ; Yong Jin JUNG ; Won Young TAK ; Sook-Hyang JEONG ; Kyung Min KWON ; Vithika SURI ; Peiwen WU ; Byoung Kuk JANG ; Byung Seok LEE ; Ju-Yeon CHO ; Jeong Won JANG ; Soo Hyun YANG ; Seung Woon PAIK ; Hyung Joon KIM ; Jung Hyun KWON ; Neung Hwa PARK ; Ju Hyun KIM ; In Hee KIM ; Sang Hoon AHN ; Young-Suk LIM
The Korean Journal of Internal Medicine 2023;38(4):504-513
Despite the availability of direct-acting antivirals (DAAs) for chronic hepatitis C virus (HCV) infection in Korea, need remains for pangenotypic regimens that can be used in the presence of hepatic impairment, comorbidities, or prior treatment failure. We investigated the efficacy and safety of sofosbuvir–velpatasvir and sofosbuvir–velpatasvir–voxilaprevir for 12 weeks in HCV-infected Korean adults. Methods: This Phase 3b, multicenter, open-label study included 2 cohorts. In Cohort 1, participants with HCV genotype 1 or 2 and who were treatment-naive or treatment-experienced with interferon-based treatments, received sofosbuvir–velpatasvir 400/100 mg/day. In Cohort 2, HCV genotype 1 infected individuals who previously received an NS5A inhibitor-containing regimen ≥ 4 weeks received sofosbuvir–velpatasvir–voxilaprevir 400/100/100 mg/day. Decompensated cirrhosis was an exclusion criterion. The primary endpoint was SVR12, defined as HCV RNA < 15 IU/mL 12 weeks following treatment. Results: Of 53 participants receiving sofosbuvir–velpatasvir, 52 (98.1%) achieved SVR12. The single participant who did not achieve SVR12 experienced an asymptomatic Grade 3 ASL/ALT elevation on day 15 and discontinued treatment. The event resolved without intervention. All 33 participants (100%) treated with sofosbuvir–velpatasvir–voxilaprevir achieved SVR 12. Overall, sofosbuvir–velpatasvir and sofosbuvir–velpatasvir–voxilaprevir were safe and well tolerated. Three participants (5.6%) in Cohort 1 and 1 participant (3.0%) in Cohort 2 had serious adverse events, but none were considered treatment-related. No deaths or grade 4 laboratory abnormalities were reported. Conclusions: Treatment with sofosbuvir–velpatasvir or sofosbuvir–velpatasvir–voxilaprevir was safe and resulted in high SVR12 rates in Korean HCV patients.
2.Clinical safety and effectiveness of the Genoss drug-eluting stent in real-world clinical practice
Young Jin YOUN ; Jun-Won LEE ; Sung Gyun AHN ; Seung-Hwan LEE ; Junghan YOON ; Jae Hyoung PARK ; Sang-Yong YOO ; Woong Chol KANG ; Nam Ho LEE ; Ki Hwan KWON ; Joon Hyung DOH ; Sang-Wook LIM ; Yang Soo JANG ; Dong Woon JEON ; Jung Ho HEO ; Woong Gil CHOI ; Sungsoo CHO ; Bong-Ki LEE ; Hyonju JEONG ; Bum-Kee HONG ; Hyun-Hee CHOI
The Korean Journal of Internal Medicine 2023;38(5):683-691
Background/Aims:
The Genoss DES™ is a novel, biodegradable, polymer-coated, sirolimus-eluting stent with a cobalt- chromium stent platform and thin strut. Although the safety and effectiveness of this stent have been previously investigated, real-world clinical outcomes data are lacking. Therefore, the aim of this prospective, multicenter trial was to evaluate the clinical safety and effectiveness of the Genoss DES™ in all-comer patients undergoing percutaneous coronary intervention.
Methods:
The Genoss DES registry is a prospective, single-arm, observational trial for evaluation of clinical outcomes after Genoss DES™ implantation in all-comer patients undergoing percutaneous coronary intervention from 17 sites in South Korea. The primary endpoint was a device-oriented composite outcome of cardiac death, target vessel-related myocardial infarction (MI), and clinically driven target lesion revascularization (TLR) at 12 months.
Results:
A total of 1,999 patients (66.4 ± 11.1 years of age; 72.8% male) were analyzed. At baseline, 62.8% and 36.7% of patients had hypertension and diabetes, respectively. The implanted stent number, diameter, and length per patient were 1.5 ± 0.8, 3.1 ± 0.5 mm, and 37.0 ± 25.0 mm, respectively. The primary endpoint occurred in 1.8% patients, with a cardiac death rate of 1.1%, target vessel-related MI rate of 0.2%, and clinically driven TLR rate of 0.8%.
Conclusions
In this real-world registry, the Genoss DES™ demonstrated excellent safety and effectiveness at 12 months among all-comer patients undergoing percutaneous coronary intervention. These findings suggest that the Genoss DES™ may be a viable treatment option for patients with coronary artery disease.
3.The Clinical Impact of β-Blocker Therapy on Patients With Chronic Coronary Artery Disease After Percutaneous Coronary Intervention
Jiesuck PARK ; Jung-Kyu HAN ; Jeehoon KANG ; In-Ho CHAE ; Sung Yun LEE ; Young Jin CHOI ; Jay Young RHEW ; Seung-Woon RHA ; Eun-Seok SHIN ; Seong-Ill WOO ; Han Cheol LEE ; Kook-Jin CHUN ; DooIl KIM ; Jin-Ok JEONG ; Jang-Whan BAE ; Han-Mo YANG ; Kyung Woo PARK ; Hyun-Jae KANG ; Bon-Kwon KOO ; Hyo-Soo KIM
Korean Circulation Journal 2022;52(7):544-555
Background and Objectives:
The outcome benefits of β-blockers in chronic coronary artery disease (CAD) have not been fully assessed. We evaluated the prognostic impact of β-blockers on patients with chronic CAD after percutaneous coronary intervention (PCI).
Methods:
A total of 3,075 patients with chronic CAD were included from the Grand DrugEluting Stent registry. We analyzed β-blocker prescriptions, including doses and types, in each patient at 3-month intervals from discharge. After propensity score matching, 1,170 pairs of patients (β-blockers vs. no β-blockers) were derived. Primary outcome was defined as a composite endpoint of all-cause death and myocardial infarction (MI). We further analyzed the outcome benefits of different doses (low-, medium-, and high-dose) and types (conventional or vasodilating) of β-blockers.
Results:
During a median (interquartile range) follow-up of 3.1 (3.0–3.1) years, 134 (5.7%) patients experienced primary outcome. Overall, β-blockers demonstrated no significant benefit in primary outcome (hazard ratio [HR], 0.88; 95% confidence interval [CI], 0.63–1.24), all-cause death (HR, 0.87; 95% CI, 0.60–1.25), and MI (HR, 1.25; 95% CI, 0.49–3.15). In subgroup analysis, β-blockers were associated with a lower risk of all-cause death in patients with previous MI and/ or revascularization (HR, 0.38; 95% CI, 0.14–0.99) (p for interaction=0.045). No significant associations were found for the clinical outcomes with different doses and types of β-blockers.
Conclusions
Overall, β-blocker therapy was not associated with better clinical outcomes in patients with chronic CAD undergoing PCI. Limited mortality benefit of β-blockers may exist for patients with previous MI and/or revascularization.
4.Caenorhabditis elegans deep lipidome profiling by using integrative mass spectrometry acquisitions reveals significantly altered lipid networks
Anh Hoang NGUYEN ; Yoon Cheol YOUNG ; Min Jin YOUNG ; Long Phuoc NGUYEN ; Jung Woon CHEOL ; Kim Jo SUN ; Kim Won SUK ; Lee Goo EUN ; Wang DAIJIE ; Wang XIAO ; Kwon Won SUNG
Journal of Pharmaceutical Analysis 2022;12(5):743-754
Lipidomics coverage improvement is essential for functional lipid and pathway construction.A powerful approach to discovering organism lipidome is to combine various data acquisitions,such as full scan mass spectrometry(full MS),data-dependent acquisition(DDA),and data-independent acquisition(DIA).Caenorhabditis elegans(C.elegans)is a useful model for discovering toxic-induced metabolism,high-throughput drug screening,and a variety of human disease pathways.To determine the lipidome of C.elegans and investigate lipid disruption from the molecular level to the system biology level,we used integrative data acquisition.The methyl-tert-butyl ether method was used to extract L4 stage C.elegans after exposure to triclosan(TCS),perfluorooctanoic acid,and nanopolystyrene(nPS).Full MS,DDA,and DIA integrations were performed to comprehensively profile the C.elegans lipidome by Q-Exactive Plus MS.All annotated lipids were then analyzed using lipid ontology and pathway analysis.We annotated up to 940 lipids from 20 lipid classes involved in various functions and pathways.The biological in-vestigations revealed that when C.elegans were exposed to nPS,lipid droplets were disrupted,whereas plasma membrane-functionalized lipids were likely to be changed in the TCS treatment group.The nPS treatment caused a significant disruption in lipid storage.Triacylglycerol,glycerophospholipid,and ether class lipids were those primarily hindered by toxicants.Finally,toxicant exposure frequently involved numerous lipid-related pathways,including the phosphoinositide 3-kinase/protein kinase B pathway.In conclusion,an integrative data acquisition strategy was used to characterize the C elegans lipidome,providing valuable biological insights into hypothesis generation and validation.
5.Ticagrelor Monotherapy After 3-Month Dual Antiplatelet Therapy in Acute Coronary Syndrome by High Bleeding Risk: The Subanalysis From the TICO Trial
Yong-Joon LEE ; Yongsung SUH ; Jung-Sun KIM ; Yun-Hyeong CHO ; Kyeong Ho YUN ; Yong Hoon KIM ; Jae Young CHO ; Ae-Young HER ; Sungsoo CHO ; Dong Woon JEON ; Sang-Yong YOO ; Deok-Kyu CHO ; Bum-Kee HONG ; Hyuckmoon KWON ; Sung-Jin HONG ; Chul-Min AHN ; Dong-Ho SHIN ; Chung-Mo NAM ; Byeong-Keuk KIM ; Young-Guk KO ; Donghoon CHOI ; Myeong-Ki HONG ; Yangsoo JANG ; For the TICO investigators
Korean Circulation Journal 2022;52(4):324-337
Background and Objectives:
Identifying patients with high bleeding risk (HBR) is important when making decisions for antiplatelet therapy strategy. This study evaluated the impact of ticagrelor monotherapy after 3-month dual antiplatelet therapy (DAPT) according to HBR in acute coronary syndrome (ACS) patients treated with drug eluting stents (DESs).
Methods:
In this post-hoc analysis of the TICO trial, HBR was defined by 2 approaches: meeting Academic Research Consortium for HBR (ARC-HBR) criteria or Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent DAPT (PRECISEDAPT) score ≥25. The primary outcome was a 3–12 months net adverse clinical event (composite of major bleeding and adverse cardiac and cerebrovascular events).
Results:
Of the 2,980 patients without adverse events during the first 3 months after DES implantation, 453 (15.2%) were HBR by ARC-HBR criteria and 504 (16.9%) were HBR by PRECISE-DAPT score. The primary outcome rate was higher in HBR versus non-HBR patients (by ARC-HBR criteria: hazard ratio [HR], 2.87; 95% confidence interval [CI], 1.76– 4.69; p<0.001; by PRECISE-DAPT score: HR, 3.09; 95% CI, 1.92–4.98; p<0.001). Ticagrelor monotherapy after 3-month DAPT was associated with lower primary outcome rate than ticagrelor-based 12-month DAPT regardless of HBR by ARC-HBR criteria, with similar magnitudes of therapy effect for HBR and non-HBR patients (p-interaction=0.400). Results were consistent by PRECISE-DAPT score (p-interaction=0.178).
Conclusions
In ACS patients treated with DESs, ticagrelor monotherapy after 3-month DAPT was associated with lower rate of adverse clinical outcomes regardless of HBR, with similar magnitudes of therapy effect between HBR and non-HBR.Trial Registration: ClinicalTrials.gov Identifier: NCT02494895
6.Prognostic Value of Alpha-Fetoprotein in Patients Who Achieve a Complete Response to Transarterial Chemoembolization for Hepatocellular Carcinoma
Jae Seung LEE ; Young Eun CHON ; Beom Kyung KIM ; Jun Yong PARK ; Do Young KIM ; Sang Hoon AHN ; Kwang-Hyub HAN ; Wonseok KANG ; Moon Seok CHOI ; Geum-Youn GWAK ; Yong-Han PAIK ; Joon Hyeok LEE ; Kwang Cheol KOH ; Seung Woon PAIK ; Hwi Young KIM ; Tae Hun KIM ; Kwon YOO ; Yeonjung HA ; Mi Na KIM ; Joo Ho LEE ; Seong Gyu HWANG ; Soon Sun KIM ; Hyo Jung CHO ; Jae Youn CHEONG ; Sung Won CHO ; Seung Ha PARK ; Nae-Yun HEO ; Young Mi HONG ; Ki Tae YOON ; Mong CHO ; Jung Gil PARK ; Min Kyu KANG ; Soo Young PARK ; Young Oh KWEON ; Won Young TAK ; Se Young JANG ; Dong Hyun SINN ; Seung Up KIM ;
Yonsei Medical Journal 2021;62(1):12-20
Purpose:
Alpha-fetoprotein (AFP) is a prognostic marker for hepatocellular carcinoma (HCC). We investigated the prognostic value of AFP levels in patients who achieved complete response (CR) to transarterial chemoembolization (TACE) for HCC.
Materials and Methods:
Between 2005 and 2018, 890 patients with HCC who achieved a CR to TACE were recruited. An AFP responder was defined as a patient who showed elevated levels of AFP (>10 ng/mL) during TACE, but showed normalization or a >50% reduction in AFP levels after achieving a CR.
Results:
Among the recruited patients, 569 (63.9%) with naïve HCC and 321 (36.1%) with recurrent HCC after complete resection were treated. Before TACE, 305 (34.3%) patients had multiple tumors, 219 (24.6%) had a maximal tumor size >3 cm, and 22 (2.5%) had portal vein tumor thrombosis. The median AFP level after achieving a CR was 6.36 ng/mL. After a CR, 473 (53.1%) patients experienced recurrence, and 417 (46.9%) died [median progression-free survival (PFS) and overall survival (OS) of 16.3 and 62.8 months, respectively]. High AFP levels at CR (>20 ng/mL) were independently associated with a shorter PFS [hazard ratio (HR)=1.403] and OS (HR=1.284), together with tumor multiplicity at TACE (HR=1.518 and 1.666, respectively). AFP non-responders at CR (76.2%, n=359 of 471) showed a shorter PFS (median 10.5 months vs. 15.5 months, HR=1.375) and OS (median 41.4 months vs. 61.8 months, HR=1.424) than AFP responders (all p=0.001).
Conclusion
High AFP levels and AFP non-responders were independently associated with poor outcomes after TACE. AFP holds clinical implications for detailed risk stratification upon achieving a CR after TACE.
7.A Rare Case of Limited Muscle Involvement in Polyarteritis Nodosa
Sung Oh SONG ; Ro Woon LEE ; Mie Jin LIM ; Seong Ryul KWON ; Won PARK
Investigative Magnetic Resonance Imaging 2021;25(1):53-58
Polyarteritis nodosa (PAN) is a systemic vasculitis involving small- and medium-sized arteries, which presents with necrotizing inflammation. PAN occurs as a systemic disease or as a limited form confined to a single organ. Few cases have been reported with single organ involvement, and even fewer have been reported with skeletal muscle involvement. Herein, we report the ultrasonography and magnetic resonance imaging findings in a rare case of PAN with limited muscle involvement in a 66-yearold man.
8.A Rare Case of Limited Muscle Involvement in Polyarteritis Nodosa
Sung Oh SONG ; Ro Woon LEE ; Mie Jin LIM ; Seong Ryul KWON ; Won PARK
Investigative Magnetic Resonance Imaging 2021;25(1):53-58
Polyarteritis nodosa (PAN) is a systemic vasculitis involving small- and medium-sized arteries, which presents with necrotizing inflammation. PAN occurs as a systemic disease or as a limited form confined to a single organ. Few cases have been reported with single organ involvement, and even fewer have been reported with skeletal muscle involvement. Herein, we report the ultrasonography and magnetic resonance imaging findings in a rare case of PAN with limited muscle involvement in a 66-yearold man.
9.Safety and Efficacy of a New Ultrathin Sirolimus-Eluting Stent with Abluminal Biodegradable Polymer in Real-World Practice
Young Jin YOUN ; Sang Yong YOO ; Jun Won LEE ; Sung Gyun AHN ; Seung Hwan LEE ; Junghan YOON ; Jae Hyoung PARK ; Woong Gil CHOI ; Sungsoo CHO ; Sang Wook LIM ; Yang Soo JANG ; Ki Hwan KWON ; Nam Ho LEE ; Joon Hyung DOH ; Woong Chol KANG ; Dong Woon JEON ; Bong Ki LEE ; Jung Ho HEO ; Bum Kee HONG ; Hyun Hee CHOI
Korean Circulation Journal 2020;50(4):317-327
BACKGROUND AND OBJECTIVES: Recently, Genoss drug-eluting stent (DES)™ stent comprising cobalt-chromium platform with an ultrathin strut thickness, sirolimus, and an abluminal biodegradable polymer was developed. Owing to the lack of substantial evidence for the safety and efficacy of this stent, we report 12-month results of the Genoss DES™ stent.METHODS: We analyzed subjects who were eligible for a 12-month follow-up from the ongoing Genoss DES™ registry, which is a prospective, single-arm, observational, multicenter trial to investigate the clinical outcomes after the successful Genoss DES™ stent implantation among all-comers. The primary endpoint was a device-oriented composite outcome, defined as cardiac death, target vessel-related myocardial infarction, and target lesion revascularization at 12-month follow-up.RESULTS: Among 622 subjects, the mean age of subjects was 66.5±10.4 years, 70.6% were males, 67.5% had hypertension, and 38.3% had diabetes. The implanted stent number, diameter, and length per patient were 1.5±0.8, 3.1±0.4 mm, and 36.0±23.3 mm, respectively. At 12-month clinical follow-up, the primary endpoint occurred only in 4 (0.6%) subjects.CONCLUSIONS: The novel Genoss DES™ stent exhibited excellent safety and efficacy in real-world practice.
Death
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Drug-Eluting Stents
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Follow-Up Studies
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Humans
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Hypertension
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Male
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Multicenter Studies as Topic
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Myocardial Infarction
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Percutaneous Coronary Intervention
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Polymers
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Prospective Studies
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Registries
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Sirolimus
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Stents
10.Appropriateness of rabies post-exposure prophylaxis in pediatric patients visiting the emergency department due to animal bite
Jhe Jun YOO ; Jung In KO ; Woon Hyung YEO ; Tae Jin PARK ; Sung Koo JUNG ; Jae Hyun KWON
Pediatric Emergency Medicine Journal 2020;7(1):23-27
Purpose:
To study the appropriateness of rabies post-exposure prophylaxis (rPEP) for children with animal bite who visited the emergency department (ED).
Methods:
The study enrolled children younger than 18 years with animal bite who visited the National Medical Center ED between January 2014 and October 2017. The children’ electronic medical records were retrospectively reviewed. Data for analysis included age, sex, body parts bitten by animals, species of animals, regions where animal bites occurred, history of recent antibiotics therapy and tetanus vaccination, and justification by the 2017 Guidelines for Rabies Control in Korea and implementation of rPEP. In children who underwent unjustified rPEP or did not undergo justified one, we recorded their guardians’ opinion for or against rPEP.
Results:
Of the 63 enrolled children, rPEP was justified for 38 children by the Korean guidelines. Of the 38 children, 35 actually underwent rPEP. Among the remaining 3 children, 2 did not undergo the prophylaxis as per the guardians’ requests. Among the 25 children whose rPEP was not justified, 8 underwent the prophylaxis. Of these 8 children, 7 did based on the guardians’ requests.
Conclusion
In this study, inappropriate rPEP was usually affected by the guardians’ requests, regardless of the criteria for such prophylaxis. Thus, their requests for or against rPEP should be discussed with emergency physicians who are aware of the relevant criteria to prevent occurrence of rabies or unnecessary use of medical resources.

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