OBJECTIVES The primary objective of the BATTLE (Bare Metal Stent vs. Paclitaxel Eluting Stent in the Setting of Primary Stenting of Intermediate-Length Femoropopliteal Lesions) trial is to demonstrate the clinical superiority of the Zilver PTX stent over the Misago stent in the treatment of femoropopliteal lesions. BACKGROUND No randomized studies have compared self-expanding paclitaxel-eluting stents with bare-metal stents in the treatment of femoropopliteal lesions. METHODS BATTLE is a multicenter randomized controlled trial in patients with symptomatic (Rutherford category 2 to 5) de novo lesions of the superficial femoral or proximal popliteal artery. The primary endpoint is freedom from in-stent restenosis (ISR) at 1 year, with restenosis defined as a peak systolic velocity index >2.4 at the target lesion. The Kaplan-Meier method was used to evaluate time-to-event data for freedom from ISR over the 2-year follow-up period. RESULTS Between March 2014 and August 2016, 186 patients were enrolled; 91 were assigned to the Misago arm and 90 to the Zilver PTX arm. Kaplan-Meier 1-year estimates of freedom from ISR were 88.6% for Misago and 91% for Zilver PTX (hazard ratio [HR]: 1.2; 95% confidence interval [CI]: 0.6 to 2.4; p = 0.64). Comparing Misago with Zilver PTX, 2-year estimates were 6.4% and 1.2% (HR: 7.3; 95% CI: 0.9 to 59.3; p = 0.0632) for mortality, 74.6% and 78.8% (HR: 1.2; 95% CI: 0.6 to 2.1; p = 0.62) for patency, and 14.4% and 12.4% (HR: 1.2; 95% CI: 0.5 to 2.8; p = 0.69) for target lesion revascularization. CONCLUSIONS In the treatment of symptomatic femoropopliteal lesions, the Zilver PTX stent failed to show superiority over the Misago stent in freedom from ISR at 1 year.

中文翻译：

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无聚合物的紫杉醇洗脱支架与裸金属支架治疗De Novo股emo关节病变：BATTLE试验。

目的BATTLE（裸金属支架vs紫杉醇洗脱支架在中长股腓总病变初次支架设置中）的主要目的是证明Zilver PTX支架在治疗股pop关节方面优于Misago支架病变。背景技术尚无随机研究比较自膨胀紫杉醇洗脱支架与裸金属支架治疗股pop病变。方法BATTLE是一项多中心随机对照试验，用于有症状的股浅或pop小动脉新生（卢瑟福2至5类）病变的患者。主要终点是在1年内无支架内再狭窄（ISR），再狭窄定义为目标病变处的收缩期峰值速度指数> 2.4。Kaplan-Meier方法用于评估2年随访期内事件发生时间数据是否不受情监侦的影响。结果2014年3月至2016年8月，共收治186例患者。91架被分配给Misago臂，90架被分配给Zilver PTX臂。Kaplan-Meier对Isava的1年无ISR估计为Misago为88.6％，Zilver PTX为91％（危险比[HR]：1.2； 95％置信区间[CI]：0.6至2.4； p = 0.64）。与Misago和Zilver PTX相比，两年死亡率估计分别为6.4％和1.2％（HR：7.3; 95％CI：0.9至59.3; p = 0.0632），74.6％和78.8％（HR：1.2; 95％CI：通畅性为0.6至2.1; p = 0.62），靶病变血运重建为14.4％和12.4％（HR：1.2; 95％CI：0.5至2.8; p = 0.69）。结论在治疗有症状的股lite病变时，