• Title/Summary/Keyword: Paclitaxel drug-coated balloon

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Paclitaxel-Coated Balloon versus Plain Balloon Angioplasty for Dysfunctional Autogenous Radiocephalic Arteriovenous Fistulas: A Prospective Randomized Controlled Trial

  • Jong Woo Kim;Jeong Ho Kim;Sung Su Byun;Jin Mo Kang;Ji Hoon Shin
    • Korean Journal of Radiology
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    • v.21 no.11
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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.

The Developing Trend of Cardiovacular Drug Coated Balloon Catheter (심장혈관용 약물코팅풍선카테터의 개발 동향)

  • Park, Junghun;Jo, Won-Il;Byeon, Dae-Heung;Kang, So Young;Nam, Choong-hyun;Seo, Kyoung-Woo;Park, Jun-Kyu
    • Applied Chemistry for Engineering
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    • v.33 no.5
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    • pp.545-550
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    • 2022
  • As a result of the rapid entry into an aging society and westernized eating habits, the number of heart disease patients caused by angina pectoris, myocardial infarction, and high blood pressure has increased by more than 100,000 over five years. Heart disease has consistently ranked second in the cause of death in Korea over the past eight years, and medical expenses consumed annually reach 6 trillion won. While various treatments are being proposed for more patients, drug-coated balloon catheters have been developed and gradually commercialized to solve the disadvantages of stent implantation such as restenosis and increased risk of bleeding due to long-term double antiplatelet medication. In Korea, it began to use a drug-coated balloon catheter with the first release of it called "SeQuent Please (Bibrown Korea)" in 2010. Its demand increased gradually as insurance benefits were applied in 2012. Drug-coated balloon angioplasty is increasing in use not only in Korea but also around the world, especially in the Asia-Pacific region, including Japan. Until now, the demand for domestic products is increasing, and if the efficiency in vivo and clinical trials is proven in the future, it is expected to be an effective procedure compared to high-risk stent implantation.

Clinical Outcomes of Atherectomy Plus Drug-coated Balloon Versus Drug-coated Balloon Alone in the Treatment of Femoropopliteal Artery Disease

  • Jung-Joon Cha;Jae-Hwan Lee;Young-Guk Ko;Jae-Hyung Roh;Yong-Hoon Yoon;Yong-Joon Lee;Seung-Jun Lee;Sung-Jin Hong;Chul-Min Ahn;Jung-Sun Kim;Byeong-Keuk Kim;Donghoon Choi;Myeong-Ki Hong;Yangsoo Jang
    • Korean Circulation Journal
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    • v.52 no.2
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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.