A.Z. Sint-Blasius Hospital, Dendermonde, Belgium.
University of Siena, Italy.
J Endovasc Ther. 2020 Apr;27(2):287-295. doi: 10.1177/1526602820902014. Epub 2020 Jan 30.
To report the 12-month results of a multicenter, prospective, randomized controlled trial to determine if the ZILVER PTX paclitaxel-eluting stent was noninferior in terms of safety and efficacy compared with surgical bypass. This is a study in symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions comparing endovascular ZILVER PTX stenting vs surgical bypass surgery using a prosthetic graft ( identifier NCT01952457). Between October 2013 and July 2017, 220 patients (mean age 68.6±10.5 years; 159 men) were enrolled and randomized to the ZILVER PTX treatment group (113, 51.4%) or the bypass treatment group (107, 48.6%). Most of the lesions were occlusions (208, 94.5%); the mean lesion length was 247.1±69.3 mm. The primary outcome measure was primary patency at 12 months, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex-derived peak systolic velocity ratio <2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass. The estimated 12-month primary patency rate was 74.5% (95% CI 66.3% to 82.7%) for the ZILVER PTX group vs 72.5% (95% CI 63.7% to 81.3%) for the bypass arm (p=0.998). Freedom from TLR at 12 months was 80.9% (95% CI 73.3% to 88.5%) for the ZILVER PTX group vs 76.2% (95% CI 68.0% to 84.4%) for the bypass group (p=0.471). The 30-day complication rate was significantly lower in the ZILVER PTX group (4.4% vs 11.3%, p=0.004). Also, procedure time and hospital stay were significantly shorter in the ZILVER PTX group (p<0.001 for both). With noninferior patency results, a lower complication rate, and shorter procedures and hospital stays, paclitaxel-eluting stenting might become a recommended treatment for long TASC C and D femoropopliteal lesions.
报告一项多中心、前瞻性、随机对照试验的 12 个月结果，以确定 ZILVER PTX 紫杉醇洗脱支架在安全性和疗效方面是否不劣于手术旁路。这是一项针对有症状的跨大西洋腔内治疗协会共识（TASC）C 和 D 股腘病变的研究，比较了血管内 ZILVER PTX 支架置入与使用假体移植物的旁路手术（标识符 NCT01952457）。2013 年 10 月至 2017 年 7 月，共纳入 220 例患者（平均年龄 68.6±10.5 岁；159 例男性），并随机分为 ZILVER PTX 治疗组（113 例，51.4%）或旁路治疗组（107 例，48.6%）。大多数病变为闭塞（208 例，94.5%）；平均病变长度为 247.1±69.3mm。主要终点为 12 个月时的一期通畅率，定义为靶病变或旁路移植段内无二元再狭窄或闭塞的证据，根据双功能超声衍生的峰值收缩速度比值<2.4 及腔内病例无临床驱动的靶病变血运重建（TLR）或旁路重建以恢复血流。ZILVER PTX 组的 12 个月一期通畅率估计为 74.5%（95%CI 66.3%至 82.7%），旁路组为 72.5%（95%CI 63.7%至 81.3%）（p=0.998）。ZILVER PTX 组 12 个月 TLR 无复发率为 80.9%（95%CI 73.3%至 88.5%），旁路组为 76.2%（95%CI 68.0%至 84.4%）（p=0.471）。ZILVER PTX 组 30 天并发症发生率显著低于旁路组（4.4%比 11.3%，p=0.004）。此外，ZILVER PTX 组的手术时间和住院时间明显缩短（p<0.001）。紫杉醇洗脱支架具有不劣的通畅率、较低的并发症发生率以及较短的手术和住院时间，可能成为 TASC C 和 D 股腘病变的推荐治疗方法。
