• Biomaterials and Biomechanics in Bioengineering
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• v.1 no.1
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• pp.13-25
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• 2014

In the current study, a drug-eluting stent coated with biodegradable polymers and sirolimus was developed by using an ultrasonic nanocoater and characterized in aspects of surface smoothness and coating thickness. In addition, in vitro release profiles of sirolimus by changing top coating layer with different biodegradable polymers were investigated. Smooth surfaces with variable thickness could be fabricated by optimizing polymer concentration, flow rate, nozzle-tip distance, gas pressure, various solvents and ultrasonic power. Smooth surface could be generated by using volatile solvents (acetone, chloroform, and methylene chloride) or post-treating with solvent vapor. Coating thickness could be controlled by varying injection volume or polymer concentration, and higher concentration could reduce the coating time while obtaining the same thickness. The thickness measurement was the most effectively performed by a conventional cutting method among three different methods that were investigated in this study. Release profiles of sirolimus were effectively controlled by changing polymers for top layer. PLGA made the release rate 3 times faster than PDLLA and PLLA and all top layers prevented burst release at the initial phase of profiles. Our results will provide useful and informative knowledge for developing drug-eluting stents, especially coated with biodegradable polymers.

• Journal of radiological science and technology
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• v.37 no.2
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• pp.109-116
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• 2014

Many studies have suggested that in the era of Drug-Eluting Stents(DES) are one of the causes of In-Stent Restenosis(ISR) of Stent Fracture(SF). The present study sought to evaluate clinical characteristics of patients with stent fracture after successful DES implantation. The 4,701 patients were selected for analysis who underwent a follow-up coronary angiography irrespective of ischemic symptoms. The overall incidence of SF was 32 patients(male:female=19:13, Av. age $62.44{\pm}9.8$year, 0.68%). Fractures of Sirolimus-Eluting Stents(SES), Paclitaxel-Eluting Stents(PES), Biolimus A9-Eluting Stents(BES), Everolimus-Eluting Etents(EES), Endothelial Progenitor Cell Capture Stent(EPC) and Zotarolimus-Eluting Stents(ZES) are accounted for 19(59.4%), 9(28.1%), 2(6.3%), 1(3.1%), 1(3.1%) and 0(0%) respectively. SF developed in the left Anterior Dscending(LAD) artery in 16 patients(50%) and in complex(type B2, C) lesions in 25 patients(69.4%). Ten patients were treated with heterogenous DES, the rest being treated with either homogenous DES(3 patients), plain old balloon angioplasty(3 patients), or conservative medical treatment(17 patients). None of the patients with SF suffered from cardiac death during a follow-up period of $32.9{\pm}12.4$ months. The overall rate of DES fracture over up to 3.7 years of follow-up was 0.68% with higher incidence in SES than in PES. SF frequently occurred in the LAD artery and in complex lesions. Of the patients with SF, coronary intervention was performed only when the binary restenosis lesion was significant. During the follow-up, patients with SF have continued on combination antiplatelet therapy. There is a very low rate of major adverse cardiac events(post-detection of SF), especially cardiac death associated with SF.

• Applied Chemistry for Engineering
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• v.31 no.5
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• pp.502-508
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• 2020

Dual drug-eluting stents (DES) is a primary treatment method for coronary arterial diseases in current interventional cardiology practice. However, their pathological results according to the sequence of coating of drugs have not been reported yet. The peptide-dopamine dissolved in acetonitrile was coated onto the Chonnam National University Hospital (CNUH) stent using an electrospinning coating machine. For secondary coating (e.g., sirolimus coating, designated as SPS), sirolimus (SRL) and poly lactic-glycolic acid (PLGA) were mixed in tetrahydrofuran (THF), and the solution was then coated on the CNUH stent that had underwent the primary peptide coating using an electrospinning and spray technique. Next, the peptide-dopamine was coated on the SRL-PLGA coated stent (PSS). In this study, it was confirmed that endothelialization was promoted without being significantly affected by the coating order (SPS or PSS). The sequence of drug and peptide coating may affect the development of restenosis and PSS was effective in the prevention of restenosis compared to that of using SPS.

• 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.

• Journal of the Korean Society of Radiology
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• v.6 no.1
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• pp.5-10
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• 2012

There is a still unsettled issue about the comparison of long-term clinical effects between sirolimus-(SES) and paclitaxel-eluting stents (PES) for the patients with acute myocardial infarction (AMI). Therefore, we performed a retrospective analysis to evaluate the 4-year clinical outcome of SES as compared with PES after percutaneous coronary intervention (PCI) in patients with AMI. From January 2004 to August 2006, all consecutive patients with acute ST-segment elevation myocardial infarction (STEMI) underwent primary PCI and acute NSTEMI underwent PCI by implantation either SES or PES were enrolled. The occurrence of death, cardiac death, recurrent infarction, target vessel revascularization (TVR) and stent thrombosis were analyzed. The composite of major adverse cardiac events (MACE; death, recurrent infarction and TVR) were also analyzed. During the study period, total 668 AMI patients had visited. Of them, total 522 patients (299 with SES and 223 with PES) were enrolled. During 4-year clinical follow-up, there were similar occurrences of death ($18.3{\pm}3.0%$ vs. $14.6{\pm}2.2%$, p=0.26), cardiac death ($11.2{\pm}2.6%$ vs. $6.8{\pm}1.52%$, p=0.39), re-infarction ($6.4{\pm}1.8%$ vs. $3.3{\pm}1.1%$, p=0.31), and stent thrombosis ($5.4{\pm}1.7%$ vs. $3.2{\pm}1.1%$, p=0.53) between the two groups, consecutively. The occurrences of TVR ($10.0{\pm}3.0%$ vs. $4.0{\pm}1.2%$, p=0.008) and MACE ($29.4{\pm}3.5%$ vs. $19.4{\pm}2.5%$, p=0.003) were significantly higher in patients treated with PES than SES. In AMI patients treated with either SES or PES implantation, SES had a significantly lower risk of TVR and MACE during 4-year clinical follow-up. Rates of death, cardiac death or recurrent infarction, and stent thrombosis were similar.

• Journal of Preventive Medicine and Public Health
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• v.36 no.4
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• pp.339-348
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• 2003

Objective : To quantify the economic value of the Sirolimus fluting Stent ($CYPHER^{TM}$) in treating acute coronary heart disease (CMD), and to assist in determining an adequate level of reimbursement for $CYPHER^{TM}$ in Korea. Methods : A decision-analytical model, developed by the Belgium Health Economics Disease Management group, was used to investigate the incremental cost-effectiveness of $CYPHER^{TM}$ versus conventional stenting. The time horizon was five years. The probabilities for clinical events at each node of the decision model were obtained from the results of large, randomized, controlled clinical trials. The initial care and follow-up direct medical costs were analyzed. The initial costs consisted of those for the initial procedure and hospitalization, The follow-vp costs included those for routine follow-up treatments, adverse reactions, revascularization and death. Defending on the perspective of the analysis, the costs were defined as insurance covered or total medical costs (=sum of insurance covered and uncovered medical costs). The cost data were obtained from the administrative data of 449 patients that received conventional stenting from five participating Korean hospitals during June 2002. Sensitivity analyses were peformed for discount rates of 3, 5 and 7%. Since the major clinical advantage of $CYPHER^{TM}$ over conventional stenting was the reduction in the revascularization rates, the economic value of $CYPHER^{TM}$, in relation to the direct medical costs of revascularization, were evaluated. If the incremental cost of $CYPHER^{TM}$ per revascularization avoided, compared to conventional stenting, was no higher than that of a revascularization itself, $CYPHER^{TM}$ would be considered as being cost-effective. Therefore, the maximum acceptable level for the reimbursement price of $CYPHER^{TM}$ making the incremental cost-effectiveness ratio equal to the cost of a revascularization was identified. Results : The average weighted initial insurance covered and total medical costs of conventional stenting were about 6,275,000 and 8,058,000 Won, respectively. The average weighted sum of the initial and 5-year follow-up insurance covered and total medical costs of conventional stenting were about 13,659,000 and 17,353,000 Won, respectively. The estimated maximum level of reimbursement price of $CYPHER^{TM}$ from the perspectives of the insurer and society were $4,126,897{\sim}4,325,161$ and $4,939,939{\sim}5,078,181$ Won, respectively. Conclusion : By evaluating the economic value of $CYPHER^{TM}$, as an alternative to conventional stenting, the results of this study are expected to provide a scientific basis for determining the acceptable level of reimbursement for $CYPHER^{TM}$.