• Korean Circulation Journal
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• 제54권9호
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• pp.519-533
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• 2024

The outstanding development in contemporary medicine, highlighted by percutaneous coronary intervention (PCI), was achieved through the adoption of drug-eluting stents (DESs). Although DES is the established therapy for patients undergoing PCI for de novo coronary artery disease (CAD), their drawbacks include restenosis, stent thrombosis, and the requirement for dual antiplatelet therapy (DAPT) with an uncertain duration regarding its optimality. Drug-coated balloon (DCB) treatment leaves nothing behind on the vessel wall, providing the benefit of avoiding stent thrombosis and not necessitating obligatory extended DAPT. After optimizing coronary blood flow, DCB treatment delivers an anti-proliferative drug directly coated on a balloon. Although more evidence is needed for the application of DCB treatment in de novo coronary lesions, recent studies suggest the safety and effectiveness of DCB treatment for diverse conditions including small and large vessel diseases, complex lesions like bifurcation lesions or diffuse or multivessel diseases, chronic total occlusion lesions, acute myocardial infarctions, patients at high risk of bleeding, and beyond. Consequently, we will review the current therapeutic choices for managing de novo CAD using DCB and assess the evidence supporting their concurrent application. Additionally, it aims to discuss future important perspectives.

• Korean Journal of Radiology
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• 제21권11호
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• pp.1239-1247
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• 2020

Objective: To report the mid-term results of a single-center randomized controlled trial comparing drug-coated balloon angioplasty (DBA) and plain balloon angioplasty (PBA) for the treatment of dysfunctional radiocephalic arteriovenous fistulas (RCAVFs). Materials and Methods: In this prospective study, 39 patients (mean age, 62.2 years; 21 males, 18 females) with RCAVFs failing due to juxta-anastomotic stenosis were randomly assigned to undergo either both DBA and PBA (n = 20, DBA group) or PBA alone (n = 19, PBA group) between June 2016 and June 2018. Primary endpoints were technical and clinical success and target lesion primary patency (TLPP); secondary outcomes were target lesion secondary patency (TLSP) and complication rates. Statistical analysis was performed using the Kaplan-Meier product limit estimator. Results: Demographic data and baseline clinical characteristics were comparable between the groups. Technical and clinical success rates were 100% in both groups. There was no significant difference between the groups in the mean duration of TLPP (DBA group: 26.7 ± 3.6 months; PBA group: 27.0 ± 3.8 months; p = 0.902) and TLSP (DBA group: 37.3 ± 2.6 months; PBA group: 40.4 ± 1.5 months; p = 0.585). No procedural or post-procedural complications were identified. Conclusion: Paclitaxel-coated balloon use did not significantly improve TLPP or TLSP in the treatment of juxta-anastomotic stenosis of dysfunctional RCAVFs.

• 공업화학
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• 제33권5호
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• pp.545-550
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• 2022

급격한 고령화 사회로의 진입과 서구화된 식습관에 의해 협심증, 심근경색증, 고혈압 등에 의한 심장질환자의 수가 5년간 10만명 이상 증가했다. 심장질환은 지난 8년간 꾸준히 국내 사망원인 2위를 기록 중이며, 이로 인해 연간 소모되는 의료비는 6조원에 달한다. 증가한 환자와 함께 다양한 치료법이 제시되고 있는 가운데, 현재 보편화 된 관상동맥중재시술 중 스텐트 삽입술의 단점인 재협착이나 장기간 이중항혈소판제 복용으로 인한 출혈의 위험 증가 등의 문제점을 보완하기 위해 약물코팅풍선카테터가 개발되어 점차 상용화되고 있는데, 국내에선 2010년 'SeQuent Please^Ⓡ (비브라운코리아)'라는 제품이 처음 출시되면서 약물코팅풍선카테터를 사용한 시술이 시작되었고, 이후 2012년 보험급여가 적용되면서 그 사용량이 본격적으로 늘어났다. 약물코팅풍선치료는 국내뿐만 아니라 전 세계적으로 사용이 증가하고 있는데, 특히 일본을 포함한 아시아태평양 지역에서 그 사용량이 급격히 증가하고 있다. 현재까지 국산 제품의 수요가 증가하고 있는 상황이며 향후, 동물시험 및 임상시험에서의 성능이 입증된다면 위험성이 높은 스텐트 삽입술에 비해 효과적인 시술이 될 것이라 예상한다.

• Korean Circulation Journal
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• 제52권2호
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• pp.134-135
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• 2022

• Korean Circulation Journal
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• 제53권3호
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• pp.191-193
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• 2023

• Korean Circulation Journal
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• 제52권6호
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• pp.444-454
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• 2022

Background and Objectives: The aim of this study was to demonstrate the efficacy and safety of treatment with drug-coated balloon (DCB) in a large real-world population. Methods: Patients treated with DCBs were included in a multicenter observational registry that enrolled patients from 18 hospitals in Korea between January 2009 and December 2017. The primary outcome was target lesion failure (TLF) defined as a composite of cardiovascular death, target vessel myocardial infarction, and clinically indicated target lesion revascularization at 12 months. Results: The study included 2,509 patients with 2,666 DCB-treated coronary artery lesions (1,688 [63.3%] with in-stent restenosis [ISR] lesions vs. 978 [36.7%] with de novo lesions). The mean age with standard deviation was 65.7±11.3 years; 65.7% of the patients were men. At 12 months, the primary outcome, TLF, occurred in 179 (6.7%), 151 (8.9%), 28 (2.9%) patients among the total, ISR, and de novo lesion populations, respectively. A history of hypertension, diabetes, acute coronary syndrome, previous coronary artery bypass graft, reduced left ventricular ejection fraction, B2C lesion and ISR lesion were independent predictors of 12 months TLF in the overall study population. Conclusions: This large multicenter DCB registry study revealed the favorable clinical outcome of DCB treatment in real-world practice in patient with ISR lesion as well as small de novo coronary lesion.

• Korean Circulation Journal
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• 제52권2호
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• pp.123-133
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• 2022

Background and Objectives: Atherectomy as a pretreatment has the potential to improve the outcomes of drug-coated balloon (DCB) treatment by reducing and modifying atherosclerotic plaques. The present study investigated the outcomes of atherectomy plus DCB (A+DCB) compared with DCB alone for the treatment of femoropopliteal artery disease. Methods: A total of 311 patients (348 limbs) underwent endovascular therapy using DCB for native femoropopliteal artery lesions at two endovascular centers. Of these, 82 limbs were treated with A+DCB and 266 limbs with DCB alone. After propensity score matching based on clinical and lesion characteristics, a total of 82 pairs was compared for immediate and mid-term outcomes. Results: For the matched study groups, the lesion length was 172.7±111.2 mm, and severe calcification was observed in 43.3%. The technical success rate was higher in the A+DCB group than in the DCB group (80.5% vs. 62.2%, p=0.015). However, the A+DCB group showed more procedure-related minor complications (37.0% vs. 13.4%, p=0.047). At 2-year follow-up, primary clinical patency (73.8% vs. 82.6%, p=0.158) and the target lesion revascularization (TLR)-free survival (84.3% vs. 88.2%, p=0.261) did not differ between the two groups. In Cox proportional hazard analysis, atherectomy showed no significant impact on the outcome of DCB treatments. Conclusions: The pretreatment with atherectomy improved technical success of DCB treatment; however, it was associated with increased minor complications. In this study, A+DCB showed no clinical benefit in terms of TLR-free survival or clinical patency compared with DCB treatment alone.

• Korean Journal of Radiology
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• 제25권6호
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• pp.565-574
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• 2024

Objective: To evaluate the safety and clinical outcomes of the Passeo-18 Lux drug-coated balloon (DCB) in endovascular revascularization procedures under real-world conditions in a Korean population with atherosclerotic disease of the infrainguinal arteries, including below-the-knee (BTK) arteries. Materials and Methods: Eight institutions in the Republic of Korea participated in this prospective, multicenter, single-arm, post-market surveillance study. Two hundred patients with Rutherford class 2-5 peripheral arterial disease and infrainguinal lesions suitable for endovascular treatment were competitively enrolled. Data were collected at baseline, the time of intervention, discharge, and 1-, 6-, 12-, and 24-month follow-up visits. The primary safety endpoint was freedom from major adverse events (MAE) within 6 months (except when limiting the time frame for procedure- or device-related mortality to within 30 days), and the primary effectiveness endpoint was freedom from clinically driven target lesion revascularization (CD-TLR) within 12 months after the procedure. Results: A total of 197 patients with 332 target lesions were analyzed. Two-thirds of the patients had diabetes mellitus, and 41.6% had chronic limb-threatening ischemia. The median target lesion length was 100 mm (interquartile range: 56-133 mm). Of the target lesions, 35.2% were occlusions, and 14.8% were located in the BTK arteries. Rate of freedom from MAE was 97.9% at 6 months, and the rate of freedom from CD-TLR was 95.0% and 92.2% at 12 and 24 months, respectively. Subgroup analysis of 43 patients and 49 target lesions involving the BTK arteries showed rate of freedom from MAE of 92.8% at 6 months and rates of freedom from CD-TLR of 88.8% and 84.4% at 12 and 24 months, respectively. Conclusion: The results of the present study, including the BTK subgroup analysis, showed outcomes comparable to those of other DCB studies, confirming the safety and effectiveness of Passeo-18 Lux DCB in the Korean population.

• Biomaterials and Biomechanics in Bioengineering
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• 제1권3호
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• pp.131-150
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• 2014

Vascular stenting has a great attention as a treatment for coronary arteries diseases as compared with percutaneous balloon angioplasty. In-stent restenosis and thrombosis are side effects resulting from using bare metal stent (BMS). Employing platelet therapy allowed to reduce the rate of thrombosis, however, the rate of restenosis remains a major problem. In 2002, drug-eluting stents (DESs) were introduced as an effort to reduce the restenosis. The commercially available DESs continue to suffer from coating defects that might lead to a series of adverse effects. Most importantly, multiple concerns remain regarding the polymer coating integrity on metal surfaces or the relation of polymer irregularities to longterm adverse events.

• Vascular Specialist International
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• 제34권4호
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• pp.94-102
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• 2018

Purpose: Aim of this study is to report real-life experience on the treatment of peripheral artery disease (PAD) with a specific drug-coated balloon (DCB), and to evaluate potential prognostic factors for outcomes. Materials and Methods: This is a retrospective study reporting outcomes in patients with PAD who were treated with the Lutonix DCB during a four-year period. Major outcomes included: all-cause mortality, amputation, clinical improvement, wound healing and target lesion revascularization (TLR). Mean follow-up was $24.2{\pm}2.3$ months. Results: Overall, 149 patients (mean age: $68.6{\pm}8.3$ years; 113 males) were treated, either for intermittent claudication (IC) (n=86) or critical limb ischemia (CLI) (n=63). More than half the target lesions (n=206 in total) were located in the superficial femoral artery and 18.0% were below-the-knee lesions. CLI patients presented more frequently with infrapopliteal (P=0.002) or multilevel disease (P=0.0004). Overall, all-cause mortality during follow-up was 10.7%, amputation-free survival was 81.2% and TLR-free survival was 96.6%. CLI patients showed higher all-cause mortality (P=0.007) and total amputation (P=0.0001) rates as well as lower clinical improvement (P=0.0002), compared to IC patients. Coronary artery disease (CAD), gangrene and infrapopliteal disease were found to be predictors for death whereas CLI and gangrene were found to be predictors for amputation, during follow-up. Conclusion: PAD treatment with Lutonix DCBs seems to be an efficient and safe endovascular strategy yielding promising results. However, CAD, gangrene, CLI and infrapopliteal lesions were found to be independent predictors for adverse outcomes. Larger series are needed to identify additional prognostic factors.