Purpose:Drug-coated balloon (DCB) has been established as first-line therapy in femoropopliteal (FP) intervention, and successful vessel preparation (VP) is considered a key element. However, the clinical impact of successful VP remains unknown. This retrospective study examined the clinical impact of successful VP in DCB FP intervention.Methods:In total, 268 patients (308 limbs) who underwent successful FP intervention using DCB without atherectomy devices for symptomatic lower extremity artery disease between March 2018 and December 2019 were included in this study (high-dose DCB: 69.8%; low-dose DCB: 30.2%). Successful VP was defined as <50% residual stenosis and <dissection grade D before DCB (the successful VP group). The primary outcome measure was primary patency, and its associated factors were evaluated.Results:The median follow-up period was 2.1 (interquartile range=1.1-2.7) years. Successful VP was achieved in 163 patients (60.8%). Primary patency and freedom from clinically-driven target lesion revascularization (CD-TLR) were significantly higher in the successful VP group than in the nonsuccessful VP group (54.2% vs 33.0%, p<0.001; 69.9% vs 57.7%, p=0.047). In the successful VP group, high-dose DCB and low-dose DCB were comparable in primary patency and freedom from CD-TLR (53.2% vs 53.6%, p=0.48; 68.7% vs 70.9%, p=0.69). In nonsuccessful VP group, high-dose DCB demonstrated numerically higher primary patency but not statistically significant than low-dose DCB (44.5% vs 16.0%, p=0.06), whereas no significant difference in freedom from CD-TLR was observed (56.0% vs 58.9%, p=0.29). On multivariate analysis, successful VP and preballoon size to reference vessel diameter ratio were significantly associated with primary patency.Conclusions:Achieving successful VP before DCB was independently associated with primary patency in DCB FP intervention.Clinical ImpactThis study revealed that the successful vessel preparation (VP) before DCB and preballoonsize to reference vessel diameter ratio were independently associated with primary patency in DCB femoropopliteal intervention. When successful VP was achieved only before DCB treatment, the clinical outcomes were comparable between high-dose DCB and low-dose DCB at midterm follow-up.To maximized DCB efficacy, successful VP is very important in daily clinical practice.

中文翻译：

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股腘药物涂层球囊血管成形术中血管准备后残余狭窄小于 50% 的影响

目的：药物涂层球囊（DCB）已被确立为股腘动脉（FP）介入治疗的一线疗法，而成功的血管准备（VP）被认为是关键要素。然而，成功的 VP 的临床影响仍然未知。这项回顾性研究探讨了成功 VP 对 DCB FP 干预的临床影响。方法：总共纳入了 2018 年 3 月至 2019 年 12 月期间因有症状的下肢动脉疾病而使用 DCB 成功进行 FP 干预而未使用旋切装置的 268 名患者（308 条肢体）。在本研究中（高剂量 DCB：69.8%；低剂量 DCB：30.2%）。成功的 VP 定义为 DCB 前残余狭窄<50%且<夹层 D 级（成功的 VP 组）。主要结局指标是主要通畅性，并评估其相关因素。结果：中位随访期为 2.1 年（四分位距=1.1-2.7）年。163 名患者 (60.8%) 获得了成功的 VP。成功 VP 组的初次通畅率和无临床驱动的靶病变血运重建 (CD-TLR) 显着高于不成功 VP 组（54.2% vs 33.0%，p<0.001；69.9% vs 57.7%，p=0.047） ）。在成功的 VP 组中，高剂量 DCB 和低剂量 DCB 在初次通畅和无 CD-TLR 方面具有可比性（53.2% vs 53.6%，p=0.48；68.7% vs 70.9%，p=0.69）。在不成功的 VP 组中，高剂量 DCB 在数值上表现出较高的初次通畅率，但与低剂量 DCB 相比没有统计学显着性（44.5% vs 16.0%，p=0.06），而在摆脱 CD-TLR 方面没有观察到显着差异（56.0%）对比 58.9%，p=0.29）。在多变量分析中，成功的 VP 和预球囊尺寸与参考血管直径的比率与初次通畅显着相关。结论：在 DCB 之前实现成功的 VP 与 DCB FP 干预中的初次通畅独立相关。临床影响这项研究表明，成功的血管准备（VP） ）之前 DCB 和预球囊尺寸与参考血管直径之比与 DCB 股腘动脉介入治疗中的主要通畅性独立相关。当仅在 DCB 治疗前获得成功的 VP 时，中期随访时高剂量 DCB 和低剂量 DCB 的临床结果具有可比性。为了最大限度地提高 DCB 疗效，成功的 VP 在日常临床实践中非常重要。