Tomoi Yusuke, Soga Yoshimitsu, Hirano Taichi, Tsunoda Kazuki, Ando Kenji
Department of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan.
Catheter Cardiovasc Interv. 2025 Sep;106(3):1543-1550. doi: 10.1002/ccd.31705. Epub 2025 Jun 25.
Although successful vessel preparation (VP) before drug-coated balloon (DCB) treatment has been found to improve primary patency, its long-term clinical impact remains uncertain.
The present study sought to assess the long-term clinical efficacy of of of successful VP before DCB treatment for de novo femoropopliteal (FP) lesions in patients with symptomatic lower extremity artery disease.
This retrospective study analyzed 268 patients (308 limbs) who underwent successful FP endovascular therapy (EVT) for symptomatic lower extremity artery disease between March 2018 and December 2019. Successful VP was defined as < 50% residual stenosis and a dissection grade below grade D before DCB treatment. The primary endpoint was limb salvage (LS) rate, whereas the secondary endpoints included overall survival rate, primary patency, and freedom from clinically driven target lesion revascularization (CD-TLR).
The median follow-up period was 4.4 (interquartile range, 1.6-5.4) years. At 5 years, the LS rate was significantly higher in the successful VP group than in the nonsuccessful VP group (94.4% vs. 87.9%, p = 0.03), but no significant difference in the overall survival rate was observed between both groups (65.6% vs. 68.7%, p = 0.82). At 5 years, the primary patency and freedom from CD-TLR were significantly higher in the successful VP group than in the nonsuccessful VP group (51.2% vs. 31.5%, p < 0.001; 65.0% vs. 51.6%, p = 0.01). Hemodialysis, chronic limb-threatening ischemia, heart failure, and successful VP before DCB treatment were identified as independent predictors of LS.
Successful VP before DCB treatment was independently associated with LS by improving long-term patency in FP-EVT.
尽管已发现药物涂层球囊(DCB)治疗前成功的血管准备(VP)可提高初始通畅率,但其长期临床影响仍不确定。
本研究旨在评估DCB治疗前成功的VP对有症状的下肢动脉疾病患者初发股腘(FP)病变的长期临床疗效。
这项回顾性研究分析了2018年3月至2019年12月期间因有症状的下肢动脉疾病接受成功的FP血管内治疗(EVT)的268例患者(308条肢体)。成功的VP定义为DCB治疗前残余狭窄<50%且夹层分级低于D级。主要终点是肢体挽救(LS)率,次要终点包括总生存率、初始通畅率和免于临床驱动的靶病变血管重建(CD-TLR)。
中位随访期为4.4(四分位间距,1.6 - 5.4)年。在5年时,成功VP组的LS率显著高于未成功VP组(94.4%对87.9%,p = 0.03),但两组间总生存率无显著差异(65.6%对68.7%,p = 0.82)。在5年时,成功VP组的初始通畅率和免于CD-TLR显著高于未成功VP组(51.2%对31.5%,p < 0.001;65.0%对51.6%,p = 0.01)。血液透析、慢性肢体威胁性缺血、心力衰竭和DCB治疗前成功的VP被确定为LS的独立预测因素。
DCB治疗前成功的VP通过改善FP-EVT的长期通畅率与LS独立相关。