• Korean Circulation Journal
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• v.52 no.5
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• pp.354-364
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• 2022

Background and objectives: To compare the safety and efficacy of a new everolimus-eluting stent with an abluminal-coated biodegradable polymer (Osstem Cardiotec Centum) with those of the Xience Alpine stent (Xience). Methods: This randomized, prospective, multicenter, parallel-designed, single-blind trial was conducted among patients with myocardial ischemia undergoing percutaneous coronary intervention (PCI) from 21st September 2018 until 3rd July 2020. The primary efficacy endpoint was in-segment late lumen loss (LLL) at 270 days after the procedure and the primary safety endpoints were major adverse cardiac events (MACE), composite of cardiac death, myocardial infarction, and target lesion revascularization. Results: We enrolled 121 patients and analyzed 113 patients who finished 270 days of follow-up for the primary efficacy endpoint. The mean age of the participants was 66.8 years. As for the primary efficacy endpoint, LLL of the Osstem Cardiotec Centum group was 0.09±0.13 mm and that of the Xience group was 0.12±0.14 mm (upper limit of 1-sided 95% confidence interval, 0.02; p for non-inferiority, 0.0084). This result demonstrates the non-inferiority of the Osstem Cardiotec Centum. As for the primary safety endpoint, MACE occurred in one patient (1.59% of the Xience group). Meanwhile, no MACE occurred in the Osstem Cardiotec Centum group. Conclusions: The Osstem Cardiotec Centum is non-inferior to the Xience Alpine^® stent and is confirmed to be safe. It could be safely and effectively applied to patients with coronary artery disease undergoing PCI.

• Bulletin of the Korean Chemical Society
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• v.30 no.5
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• pp.1085-1087
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• 2009

Bare metal stents which were used to treat coronary artery disease have several biochemical problems. Polymerbased drug-eluting stents (DES) have opened up a new paradigm in the treatment of in-stent restenosis. Many studies and research programmes have proved that DES can prevent restenosis. In our study, paclitaxel-loaded poly (lactic-co-glycolic acid) (PLGA) nanoparticles have been deposited along the three dimensional scaffold of coronary stents by a method using self-assembling properties of colloidal particles. We found that the nanoparticles were deposited uniformly and closely packed. The amount of paclitaxel was easily controlled by the drug content of the nanoparticles and the deposition count.

• Journal of the Korean Society of Radiology
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• v.14 no.2
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• pp.179-191
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• 2020

The aim of this study was to investigate the predictors of major adverse cardiac events (MACE) in patients with drug-eluting balloon (DEB) for in-stent restenosis (ISR) lesion. Total of 257 patients who developed ISR on follow-up coronary angiography (66.1 ± 10.1years, 172 males) in Chonnam National University Hospital between October 2012 and January 2017 were enrolled. We divided the patients into two groups; group I (MACE group; n= 35) and group II (No MACE group; n= 222). A multivariate logistic regression analysis revealed that type IV ISR (HR=4.179, 95% C.I.=1.851-9.437 p= 0.001), lesion length > 25 mm (HR=8.773, 95% C.I.=1.898-40.546 p=0.005), number of ISR recurrence > 2 (HR=4.693, 95% C.I.=1.259-17.490 p= 0.021) were independent factors for MACE after DEB in ISR lesions.

• Korean Circulation Journal
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• v.54 no.6
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• pp.339-350
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• 2024

Background and Objectives: Ultimaster^TM, a third-generation sirolimus-eluting stent using biodegradable polymer, has been introduced to overcome long term adverse vascular events, such as restenosis or stent thrombosis. In the present study, we aimed to evaluate the 12-month clinical outcomes of Ultimaster^TM stents in Korean patients with coronary artery disease. Methods: This study is a multicenter, prospective, observational registry across 12 hospitals. To reflect real-world clinical evidence, non-selective subtypes of patients and lesions were included in this study. The study end point was target lesion failure (TLF) (the composite of cardiac death, target vessel myocardial infarction [MI], and target lesion revascularization [TLR]) at 12-month clinical follow up. Results: A total of 576 patients were enrolled between November 2016 and May 2021. Most of the patients were male (76.5%), with a mean age of 66.0±11.2 years. Among the included patients, 40.1% had diabetes mellitus (DM) and 67.9% had acute coronary syndrome (ACS). At 12 months, the incidence of TLF was 4.1%. The incidence of cardiac death was 1.5%, MI was 1.0%, TLR was 2.7%, and stent thrombosis was 0.6%. In subgroup analysis based on the presence of ACS, DM, hypertension, dyslipidemia, or bifurcation, there were no major differences in the incidence of the primary endpoint. Conclusions: The present registry shows that Ultimaster^TM stent is safe and effective for routine real-world clinical practice in non-selective Korean patients, having a low rate of adverse events at least up to 12 months.

• 대한임상약리학회:학술대회논문집
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• 2005.12a
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• pp.6-6
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• 2005

• Health Policy and Management
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• v.26 no.4
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• pp.333-342
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• 2016

Background: The use of therapeutic materials based on new health technology has increased in recent years in the field of medicine, raising concerns for medical practitioners regarding increased spending on the new therapeutic materials amid the rapid population ageing and increase of chronic diseases in Korea. While therapeutic materials have significant importance in the health care system, they have not been given appropriate attention in the academic world of Korea. The purpose of this study is to identify factors that affect the growth of expenditure on therapeutic materials and to derive implications for an effective management considering the diversity of therapeutic materials. Methods: Using the claims data of the National Health Insurance Services, specific utilization patterns of groups of therapeutic materials in the middle classification level of Health Insurance Review and Assessment Service from 2007 to 2014 were analyzed. Four categories (J5083: drug eluting coronary stent, D0302: nonmetallic anchor, K6014: gauze, K6023: gauze) that exhibit unique patterns with respect to price and volume were selected. Then, decomposition analysis was performed to identify the largest contributor to the spending growth by dividing the products into existing, new, and abandoned products for the period between 2010 and 2013. Results: The effect of new products had larger impact on spending growth than the effect of core items in drug eluting coronary stent (J5083) and nonmetallic anchor (D0302). In addition, existing products in general included items priced relatively lower when compared with another item manufactured by the same company. In the gauze category, however, existing products had the largest impact on expenditure and the effect of volume was greater than that in other categories. Conclusion: This study provides evidence that appropriate management measures classified by the characteristics of therapeutic materials are required for therapeutic materials pricing and reassessment in Korea.

• Korean Circulation Journal
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• v.48 no.11
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• pp.989-999
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• 2018

Background and Objectives: We aimed to compare outcomes of complete revascularization (CR) versus culprit-only revascularization for ST-segment elevation myocardial infarction (STEMI) and multivessel disease (MVD) in the $2^{nd}$ generation drug-eluting stent (DES) era. Methods: From 2009 to 2014, patients with STEMI and MVD, who underwent primary percutaneous coronary intervention (PCI) using a $2^{nd}$ generation DES for culprit lesions were enrolled. CR was defined as PCI for a non-infarct-related artery during the index admission. Major adverse cardiovascular event (MACE) was defined as cardiovascular (CV) death, non-fatal myocardial infarction, target lesion revascularization, or heart failure during the follow-up year. Results: In total, 705 MVD patients were suitable for the analysis, of whom 286 (41%) underwent culprit-only PCI and 419 (59%) underwent CR during the index admission. The incidence of MACE was 11.5% in the CR group versus 18.5% in the culprit-only group (hazard ratio [HR], 0.56; 95% confidence interval [CI], 0.37-0.86; p<0.01; adjusted HR, 0.64; 95% CI, 0.40-0.99; p=0.04). The CR group revealed a significantly lower incidence of CV death (7.2% vs. 12.9%; HR, 0.51; 95% CI, 0.31-0.86; p=0.01 and adjusted HR, 0.57; 95% CI; 0.32-0.97; p=0.03, respectively). Conclusions: CR was associated with better outcomes including reductions in MACE and CV death at 1 year of follow-up compared with culprit-only PCI in the $2^{nd}$ generation DES era.

• Journal of the Korean Society of Radiology
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• v.6 no.2
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• pp.93-98
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• 2012

Micro-computed tomography (microCT) is an important tool for preclinical vascular imaging, with micron-level resolution. This non-destructive means of imaging allows for rapid collection of 2D and 3D reconstructions to visualize specimens prior to destructive analysis such as pathological analysis. Objectives. The aim of this study was to suggest a method for ex vivo, postmortem examination of stented arterial segments with microCT. And ex vivo evaluation of stents such as bare metal or drug eluting stents on in-stent restenosis (ISR) in rabbit model was performed. The bare metal stent (BMS) and drug eluting stent (DES, paclitaxel) were implanted in the left or right iliac arteries alternatively in eight New Zealand white rabbits. After 4 weeks of post-implantation, the part of iliac arteries surrounding the stent were removed carefully and processed for microCT. Prior to microCT analysis, a contrast medium was loaded to lumen of stents. All samples were subjected to an X-ray source operating at 50 kV and 200 ${\mu}A$ by using a 3D isotropic resolution. The region of interest was traced and measured by CTAN analytical software. Objects being exposed to radiation had different Hounsfield unit each other with values of approximately 1.2 at stent area, 0.12 ~ 0.17 at a contrast medium and 0 ~ 0.06 at outer area of stent. Based on above, further analyses were performed. As a result, the difference of lengths and volumes between expanded stents, which may relate to injury score in pathological analysis, was not different significantly. Moreover, ISR area of BMS was 1.6 times higher than that of DES, indicating that paclitaxel has inhibitory effect on cell proliferation and prevent infiltration of restenosis into lumen of stent. And ISR area of BMS was higher ($1.52{\pm}0.48mm^2$) than that of DES ($0.94{\pm}0.42mm^2$), indicating that paclitaxel has inhibitory effect on cell proliferation and prevent infiltration of restenosis into lumen of stent. Though it was not statistically significant, it showed that the extent of neointema of mid-region of stents was relatively higher than that of anterior and posterior region in parts of BMS as showing cross-sectional 2-D image. suggest that microCT can be utilized as an accessorial tool for pathological analysis.

• Nuclear Medicine and Molecular Imaging
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• v.40 no.2
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• pp.113-119
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• 2006

Coronary artery disease is a loading cause of morbidity and mortality across the world. Percutaneous coronary intervention has become the major technique of revascularization. However, restenosis remains a major limitation of this procedure. Recently the need for repeat intervention due to restenosis, the most vexing long-term failure of percutaneous coronary intervention, has been significantly reduced owing to the introduction of two major advances, intracoronary brachytherapy and the drug-eluting stents. Intracoronary brachytherapy has been employed in recent years to prevent restenosis lesions with effective results, principally in in-stent restenosis. Restenosis is generally considered as au excessive form of normal wound healing divided up in precesses: elastic recoil, neointimal hyperplasia, and negative vascular remodeling. Restenosis has previously been regarded as a proliferative process in which neointimal thickening, mediated by a cascade of inflammatory mediators and other factors, is the key factor. Ionizing radiation has been shown to decrease the proliferative response to injury in animal models of restenosis. Subsequently, several randomized, double blind trials have demonstrated that intracoronary brachytherapy can reduce the rates of both angiographic restenosis and clinical event rates in patients undergoing percutaneous coronary intervention for in stent restenosis. Some problems, such as late thrombosis and edge restenosis, have been identified as limiting factors of this technique. Brachytherapy is a promising method of preventing and treating coronary artery restenosis.

• Bulletin of the Korean Chemical Society
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• v.30 no.9
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• pp.1985-1988
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• 2009

Poly (lactic-co-glycolic acid) (PLGA) nanoparticles loading paclitaxel have been deposited on coronary stents by self-assembling properties of colloidal particles. The layers of the nanoparticles were enhanced to a sufficient mechanical strength by a thermal process under the proper temperature and humidity conditions. In vitro release studies proved the controlled paclitaxel release of the nanoparticle layers. This technique gives rise to a new range of applications for nanoparticles and drug-eluting stents.