The short-term efficacy of paclitaxel-coated balloons (PCBs) has been established in femoropopliteal in-stent restenosis (ISR) lesions. The aim of this study was to compare 5-year clinical outcomes of patients with femoropopliteal ISR lesions undergoing percutaneous transluminal angioplasty (PTA) with and without PCB. After 1:1 propensity score matching, we extracted 50 patients with femoropopliteal ISR lesions undergoing PTA with (n = 25) and without (n = 25) IN.PACT PCB (Medtronic, Minneapolis, MN) from 106 consecutive ISR patients treated in our hospital between 2009 and 2015. We compared the 5-year outcomes between PCB and non-PCB groups. The primary endpoint was the cumulative 5-year incidence of recurrent restenosis. All-cause mortality, target lesion revascularization (TLR) and unplanned major amputation were also assessed. The primary patency after PCB treatment at 5 years was significantly higher than the patency after non-PCB treatment (65.7% vs. 18.7%; hazard ratio [HR]: 6.11; 95% confidence intervals [CI]: 2.57–16.82; p < 0.001), as well as freedom from TLR (77.6% vs. 53.8%; HR: 3.55; 95% CI: 1.21–12.83; p = 0.020). All-cause mortality and unplanned major amputation rates did not significantly differ between the two groups. The Cox proportional hazard multivariate analysis showed that PCB was independently associated with preventing recurrent restenosis (HR: 0.17; 95% CI: 0.06–0.41; p < 0.001). At 5 years, patients with femoropopliteal ISR lesions undergoing PCB treatment showed significantly lower recurrent restenosis than those that underwent non-PCB treatment. Level of Evidence: Level 2b, Non-randomized controlled cohort/follow-up study.

中文翻译：

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药物涂层球囊治疗股pop病变支架内再狭窄的长期临床效果

紫杉醇涂层球囊（PCBs）在股pop支架内再狭窄（ISR）病变中的短期疗效已经确定。本研究的目的是比较接受和不接受PCB的经皮腔内血管成形术（PTA）的股pop ISR病变患者的5年临床结果。在1：1倾向评分匹配后，我们从106例接受ISR治疗的ISR患者中抽取了50例接受PTA的股fe ISR病变患者，其中（n = 25）和不使用（n = 25）IN.PACT PCB（Medtronic，明尼阿波利斯，明尼苏达州）医院在2009年至2015年之间。我们比较了PCB和非PCB组的5年结局。主要终点是复发性再狭窄的5年累积发生率。还评估了全因死亡率，目标病变血运重建（TLR）和计划外的大截肢。5年后多氯联苯治疗后的主要通畅率显着高于非多氯联苯治疗后的通畅率（65.7％比18.7％；危险比[HR]：6.11； 95％置信区间[CI]：2.57-16-1.82； p < 0.001），以及不受TLR限制（77.6％vs. 53.8％； HR：3.55； 95％CI：1.21-12.83； p = 0.020）。两组之间的全因死亡率和计划外大截肢率没有显着差异。Cox比例风险多元分析表明，PCB与预防再发性再狭窄独立相关（HR：0.17； 95％CI：0.06-0.41； p <0.001）。5年时，接受PCB治疗的股pop ISR病变患者的复发性再狭窄明显低于未接受PCB治疗的患者。证据水平：2b级，非随机对照队列/随访研究。