• 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.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.