Abstract：
BACKGROUND: Limited comparative data exist on different interventional strategies for endovascular revascularization of complex femoropopliteal interventions.
OBJECTIVE: In this study, the authors aimed to compare a stent-avoiding (SA) vs a stent-preferred (SP) strategy, promoting optimal lesion preparation and the use of drug-eluting technologies in both arms.
METHODS: Within a prospective, multicenter, pilot study, 120 patients with symptomatic complex femoropopliteal lesions (Rutherford classification 2-4, mean lesion length 187.7 ± 78.3 mm, 79.2% total occlusions) were randomly assigned in a 1:1 fashion to endovascular treatment with either paclitaxel-coated balloons or polymer-coated, paclitaxel-eluting stents. Lesion preparation including the use of devices for plaque modification and/or removal was at the operators\' discretion in both treatment arms.
RESULTS: In the SA group, lesion preparation was more frequently performed (71.7% SA [43/60] vs 51.7% [31/60] SP; P = 0.038) with a high provisional stenting rate (48.3% [29/60]). At the 12-month follow-up, primary patency was 78.2% (43/55) in the SA group and 78.6% (44/56) in the SP group (P = 1.0; relative risk: 0.995; 95% CI: 0.818-1.210). Freedom from major adverse events was determined in 93.1% (54/58) in the SA group and in 94.9% (56/59) in the SP group (P = 0.717; relative risk: 0.981; 95% CI: 0.895-1.075), with all adverse events attributable to clinically driven target lesion revascularization.
CONCLUSIONS: Both endovascular strategies promoting lesion preparation before the use of drug-eluting devices suggest promising efficacy and safety results in complex femoropopliteal procedures with a high proportion of total occlusions through 12 months. Ongoing follow-up will show whether different results emerge over time. (Best Endovascular Strategy for Complex Lesions of the Superficial Femoral Artery [BEST-SFA]; NCT03776799).
OBJECTIVE: In this study, the authors aimed to compare a stent-avoiding (SA) vs a stent-preferred (SP) strategy, promoting optimal lesion preparation and the use of drug-eluting technologies in both arms.
METHODS: Within a prospective, multicenter, pilot study, 120 patients with symptomatic complex femoropopliteal lesions (Rutherford classification 2-4, mean lesion length 187.7 ± 78.3 mm, 79.2% total occlusions) were randomly assigned in a 1:1 fashion to endovascular treatment with either paclitaxel-coated balloons or polymer-coated, paclitaxel-eluting stents. Lesion preparation including the use of devices for plaque modification and/or removal was at the operators\' discretion in both treatment arms.
RESULTS: In the SA group, lesion preparation was more frequently performed (71.7% SA [43/60] vs 51.7% [31/60] SP; P = 0.038) with a high provisional stenting rate (48.3% [29/60]). At the 12-month follow-up, primary patency was 78.2% (43/55) in the SA group and 78.6% (44/56) in the SP group (P = 1.0; relative risk: 0.995; 95% CI: 0.818-1.210). Freedom from major adverse events was determined in 93.1% (54/58) in the SA group and in 94.9% (56/59) in the SP group (P = 0.717; relative risk: 0.981; 95% CI: 0.895-1.075), with all adverse events attributable to clinically driven target lesion revascularization.
CONCLUSIONS: Both endovascular strategies promoting lesion preparation before the use of drug-eluting devices suggest promising efficacy and safety results in complex femoropopliteal procedures with a high proportion of total occlusions through 12 months. Ongoing follow-up will show whether different results emerge over time. (Best Endovascular Strategy for Complex Lesions of the Superficial Femoral Artery [BEST-SFA]; NCT03776799).
摘要：
背景：关于复杂股pop血管内血运重建的不同介入策略的比较数据有限。
目的：在本研究中，作者旨在比较支架避免（SA）和支架优先（SP）策略，促进最佳的病变准备和药物洗脱技术的使用。
方法：在预期的范围内，多中心，试点研究,120例有症状的股pop复杂病变（Rutherford分类2-4，平均病变长度187.7±78.3mm，79.2％的总闭塞）以1：1的方式随机分配给紫杉醇涂层球囊或聚合物涂层的血管内治疗，紫杉醇洗脱支架。在两个治疗组中,包括使用装置进行斑块修饰和/或去除,由操作者自行决定。
结果：在SA组中，病变准备更频繁(71.7%SA[43/60]vs51.7%[31/60]SP;P=0.038),临时支架置入率高(48.3%[29/60])。在12个月的随访中，SA组为78.2%(43/55),SP组为78.6%(44/56)(P=1.0;相对危险度:0.995;95%CI:0.818-1.210).SA组为93.1%（54/58），SP组为94.9%（56/59）（P=0.717；相对危险度：0.981；95%CI：0.895-1.075），所有不良事件均归因于临床驱动的靶病变血运重建。
结论：在使用药物洗脱装置之前促进病变准备的两种血管内策略均表明，在复杂的股pop手术中具有良好的疗效和安全性，并且在12个月内总闭塞的比例很高。持续的后续行动将显示随着时间的推移是否会出现不同的结果。（股浅动脉复杂病变的最佳血管内治疗策略[BEST-SFA]；NCT03776799）。
目的：在本研究中，作者旨在比较支架避免（SA）和支架优先（SP）策略，促进最佳的病变准备和药物洗脱技术的使用。
方法：在预期的范围内，多中心，试点研究,120例有症状的股pop复杂病变（Rutherford分类2-4，平均病变长度187.7±78.3mm，79.2％的总闭塞）以1：1的方式随机分配给紫杉醇涂层球囊或聚合物涂层的血管内治疗，紫杉醇洗脱支架。在两个治疗组中,包括使用装置进行斑块修饰和/或去除,由操作者自行决定。
结果：在SA组中，病变准备更频繁(71.7%SA[43/60]vs51.7%[31/60]SP;P=0.038),临时支架置入率高(48.3%[29/60])。在12个月的随访中，SA组为78.2%(43/55),SP组为78.6%(44/56)(P=1.0;相对危险度:0.995;95%CI:0.818-1.210).SA组为93.1%（54/58），SP组为94.9%（56/59）（P=0.717；相对危险度：0.981；95%CI：0.895-1.075），所有不良事件均归因于临床驱动的靶病变血运重建。
结论：在使用药物洗脱装置之前促进病变准备的两种血管内策略均表明，在复杂的股pop手术中具有良好的疗效和安全性，并且在12个月内总闭塞的比例很高。持续的后续行动将显示随着时间的推移是否会出现不同的结果。（股浅动脉复杂病变的最佳血管内治疗策略[BEST-SFA]；NCT03776799）。
