• 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.

• 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.

• Journal of the Korean Society of Radiology
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• v.14 no.3
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• pp.319-336
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• 2020

The purpose of this study was to compare the outcomes of two interventional methods, overlapping drug-eluting stents (DES) and long DES, for long-term clinical outcomes in patients with acute myocardial infarction (AMI). A total of 438 patients with AMI (65.9±11.0 years, 306 males) from June 2008 to March 2019 who had diffuse long coronary artery lesion, more than 30mm were divided into two groups; group I (overlapped DES group; n=140) and group II (long DES group; n=298). We compared the incidences of major adverse cardiac events [MACEs; cardiac death, myocardial infaction (MI), target lesion revascularization (TLR) and stent thrombosis (ST)] during 12 months between the two groups. Everolimus-eluting stent was more commonly used in group II than in group I (28.1% vs. 51.8% p<0.001). Mean lesion diameter was slightly longer in group II (3.1±0.3mm vs. 3.2±0.3mm, p=0.042), and prevalence of ACC/AHA lesion type C was higher in group I (41.7% vs. 25.4%, p<0.001). Incidences of MACEs during 12 months were higher in group I than group II (18.5% vs. 14.4%, p=0.034). The rates of cardiac death (2.1% vs. 4.4%, p=0.667), MI (5.0% vs. 2.7%, p=0.260) and stent thrombosis rate (0.7% vs. 1.7%, p=0.669) were similar between the two groups. However, TLR rate was higher in group I (10.7% vs. 5.6%, p=0.041). In multivariate logistic regression analysis, presence of diabetes mellitus [Hazard ratio (HR) 2.383, 95% confidence interval (CI) 1.332-4.260, p=0.003] and use of paclitaxel-eluting stent (HR) 2.367, 95% CI 1.371-4.086, p=0.002) were independent predictors of 12-month MACEs, without significant differences in prevalence between the two groups. In AMI patients with diffuse long lesion, TLR rate was higher in the overlapped DES group during 12-month follow-up. Presence of diabetes and use of paclitaxel-eluting stent were independent predictors of MACEs.

• 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.

• Polymer(Korea)
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• v.32 no.3
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• pp.284-289
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• 2008

Polymer is a critical component of local drug delivery to prevent restenosis. This study tested whether poly(n-butylmethacrylate)(PBMA) and poly(3-hydroxybutyrate-co-4-hydroxybutyrate)(PHA) was candidates for this purpose. In vitro release of paclitaxel from PBMA and PHA loaded with 10% paclitaxel exhibited a triphasic release profile, with a fast initial and intermediate second phase followed by a slow release phase. Perivascular delivery of paclitaxel using these films inhibited neointimal hyperplasia in balloon-injured rat carotid arteries. The paclitaxel-loaded PBMA or PHA groups showed significant neointimal formation reductions versus the control groups (PBMA vs control: $0.03{\pm}0.02$ vs $0.10{\pm}0.01\;mm^2$, p<0.05; PHA vs control: $0.04{\pm}0.03$ vs $0.09{\pm}0.01\;mm^2$, p<0.05). This study suggests that PBMA and PHA could be good candidate polymers of local drug delivery to prevent restenosis. Perivascular delivery using these films represents a possible approach for prevention of restenosis. These can be candidate polymers for drug eluting stents.

• Journal of the Korean Society of Radiology
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• v.82 no.3
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• pp.500-511
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• 2021

The prevalence of lower extremity disease is increasing with age. With recent technological advancements, endovascular treatment is being performed more frequently. The treatment goal of intermittent claudication is to improve walking and reduce claudication. To achieve these goals, anatomical durability and patency are important. In patients with critical limb ischemia, the lesions are diffuse and particularly severe in below-the-knee arteries. The treatment goal of critical limb ischemia is to promote wound healing and to prevent major amputation, which is evaluated by the limb salvage rate. Primary stenting using covered or bare metal stents is a widely accepted endovascular treatment. While drug-eluting technologies with or without atherectomy are widely used in the treatment of femoropopliteal disease, balloon angioplasty is the mainstay treatment for below-the-knee intervention. CT angiography provides a road map for planning endovascular treatment in patients without absolute contraindications.

• Journal of the Korean Society of Radiology
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• v.82 no.3
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• pp.551-561
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• 2021

Atherectomy has become a promising treatment option for peripheral artery disease caused by diabetes mellitus or end-stage renal disease. Atherectomy refers to the removal of atheromatous tissue by mechanical method, resulting in an enlarged lumen of the treated blood vessel. Based on this method, the term is limited to the percutaneous minimally invasive approach, and there are currently two types of atherectomy devices available in Korea. The increased prevalence of atherectomy has led to the concept of "vascular preparation" and a new treatment concept of "leave nothing behind." Various studies have proven the safety and effectiveness of atherectomy; however, there are some limitations. We need to remain focused on patient selection and subsequent large-scale research.

• The Korean Society of Law and Medicine
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• v.18 no.2
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• pp.163-194
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• 2017

Coronary artery disease has increased in Korea as the country enters the aged society. It is well known that the incidence of coronary artery disease is related to aging, hypertension, diabetes, hyperlipidemia, and dietary habit. For effective treatment of significant coronary stenosis, close coordination between cardiac surgery and cardiology team is essential. Especially cardiologists' decision whether to do the stent placement or CABG is very important because the cardiologists usually start to consult the patients for their treatment. Recently, non-surgical interventions(that is stent placement) in cardiology field have dramatically increased as the national insurance system removed the limitation of the number of stents deployed. However, accidents are often caused by inappropriate use of stents, especially in patients with triple coronary disease or left main disease with heavy coronary calcifications. Another aspect of stent placement is to cope with an emergency case in the event of coronary rupture or pericardial tamponade during coronary interventions without cardiac surgeons. In the past two years, the Korea Consumer Agency (Consumer Dispute Coordination Committee) analyzed eight cases of medical dispute settlement. Only two hospitals were manned with both cardiologists and cardiac surgeons. Seven patients died of procedures of stenting and five patients died on the day of the procedure. Among the 8 cases, 5 cases showed 3 vessel disease and the rest of the cases had either severe calcification, complete occlusion or poor coronary antomies for stenting According to a 2017 national data registry of coronary stenting, less than 3 drug-eluting stents were implanted in 98% of all patients. In 2015, the number of stent procedures was 38,922, and approximately in 800 (2%) cases, more than four stents were used per patient. We emphasize that it is necessary to seriously consider the cost-benefit analysis between stent and CABG. The patient has the right to choose the right procedure by asking the liability of 'instruction explanation obligation'. He should be well informed of the pros and cons of both procedures to avoid overuse of stent. It can be solved by intimate discussion of individual cases with the cardiac surgeon and the patient. Unilateral dialogue with the patient, forceful restriction on the number of stenting, lack of surgeon's backup in difficult cases should all be avoided. It is also necessary to solve the problem not only at the hospital level, such as multidisciplinary integrated medical care, but also a nationwide solution such as expanding cardiac surgeons as essential personnel to public officials.

• Journal of Chest Surgery
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• v.41 no.2
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• pp.202-209
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• 2008

Background: The introduction of Drug Eluting Stents (DES) decreased the number of patients referred for coronary artery bypass grafting (CABG). The impact of DES on CABG (Step 1) was studied and compared with the 1-year outcome after CABG with DES (Step 2). Material and Method: Surgical results for patients who underwent off-pump CABG (OPCAB) before the introduction of DES(n=298) were compared with those who underwent OPCAB after the introduction of DES (n=288) (Step 1). Postoperative 30-day and 1-year results were also compared between the patients who underwent percutaneous coronary intervention (PCI) using DES (n=220) and those who underwent OPCAB (n=255) (Step 2). Result: Since the introduction of DES, the ratio of CABG versus PCI decreased. In the CABG group, the number of high risk patients such as elderly patients (age 62 vs. 64, p=0.023), those with chronic renal failure (4% vs. 9%, p=0.021), calcification of the ascending aorta (9% vs. 15%, p=0.043), or frequency of urgent or emergent operations (12% vs. 22%, p=0.002) increased. However, there were no differences in the cardiac death and graft patency rates between the two groups (step 1). During the one-year follow up period, the rate of target vessel revascularization (12.3% vs. 2.4%, p<0.001) and major adverse cardiac events (MACE: death, myocardial infarct, TVR) were higher in the DES than the CABG group (13.6% vs 4.3%) (stage 2). Conclusion: Introduction of DES decreased the number of patients referred for surgery, and increased the comorbidity in patients who underwent CABG. DES increased the rate of target vessel revascularization, and the occurrence of MACE during the 1-year follow-up. However, there was no difference in the incidence of myocardial infarction and cardiac death between the two groups.

• Korean Circulation Journal
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• v.52 no.4
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• pp.324-337
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• 2022

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 (PRECISE-DAPT) 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.