Park Jong-Il, Ko Young-Guk, Lee Seung-Jun, Ahn Chul-Min, Rha Seung-Woon, Yu Cheol-Woong, Park Jong Kwan, Park Sang-Ho, Lee Jae-Hwan, Kim Su-Hong, Lee Yong-Joon, Hong Sung-Jin, Kim Jung-Sun, Kim Byeong-Keuk, Hong Myeong-Ki, Choi Donghoon
Division of Cardiology, Yeungnam University Medical Center, Yeungnam University College of Medicine, Daegu, Korea.
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea.
Korean Circ J. 2024 Aug;54(8):454-465. doi: 10.4070/kcj.2024.0006. Epub 2024 Apr 29.
The popliteal artery is generally regarded as a "no-stent zone." Limited data are available on the outcomes of drug-coated balloons (DCBs) for popliteal artery disease. This study aimed to evaluate the 12-month clinical outcomes among patients who received DCB treatment for atherosclerotic popliteal artery disease.
This prospective, multicenter registry study enrolled 100 patients from 7 Korean endovascular centers who underwent endovascular therapy using IN.PACT DCB (Medtronic) for symptomatic atherosclerotic popliteal artery disease. The primary endpoint was 12-month clinical primary patency and the secondary endpoint was clinically driven target lesion revascularization (TLR)-free rate.
The mean age of the study cohort was 65.7±10.8 years, and 77% of enrolled patients were men. The mean lesion length was 93.7±53.7 mm, and total occlusions were present in 45% of patients. Technical success was achieved in all patients. Combined atherectomy was performed in 17% and provisional stenting was required in 11%. Out of the enrolled patients, 91 patients completed the 12-month follow-up. Clinical primary patency and TLR-free survival rates at 12 months were 76.0% and 87.2%, respectively. A multivariate Cox regression analysis identified female and longer lesion length as the significant independent predictors of loss of patency.
DCB treatment yielded favorable 12-month clinical primary patency and TLR-free survival outcomes in patients with popliteal artery disease.
ClinicalTrials.gov Identifier: NCT02698345.
腘动脉通常被视为“无支架区域”。关于药物涂层球囊（DCB）治疗腘动脉疾病的疗效数据有限。本研究旨在评估接受DCB治疗的动脉粥样硬化性腘动脉疾病患者的12个月临床疗效。
这项前瞻性、多中心注册研究纳入了来自7个韩国血管内治疗中心的100例患者，这些患者因有症状的动脉粥样硬化性腘动脉疾病接受了使用IN.PACT DCB（美敦力公司）的血管内治疗。主要终点为12个月临床原发通畅率，次要终点为临床驱动的靶病变血管重建（TLR）无发生率。
研究队列的平均年龄为65.7±10.8岁，77%的入组患者为男性。平均病变长度为93.7±53.7毫米，45%的患者存在完全闭塞。所有患者均取得技术成功。17%的患者接受了联合斑块旋切术，11%的患者需要临时支架置入。在入组患者中，91例完成了12个月的随访。12个月时的临床原发通畅率和无TLR生存率分别为76.0%和87.2%。多因素Cox回归分析确定女性和病变长度较长是通畅性丧失的显著独立预测因素。
DCB治疗在腘动脉疾病患者中产生了良好的12个月临床原发通畅率和无TLR生存结局。
ClinicalTrials.gov标识符：NCT02698345。
