RAPID 随机试验的短期结果：Legflow 紫杉醇洗脱球囊联合 Supera 支架与单独使用 Supera 支架治疗中长段股浅动脉病变的比较。

Short-term Results of the RAPID Randomized Trial of the Legflow Paclitaxel-Eluting Balloon With Supera Stenting vs Supera Stenting Alone for the Treatment of Intermediate and Long Superficial Femoral Artery Lesions.

机构信息

1 Department of Interventional Radiology, St Antonius Hospital, Nieuwegein, the Netherlands.

2 Department of Vascular Surgery, St Antonius Hospital, Nieuwegein, the Netherlands.

出版信息

J Endovasc Ther. 2017 Dec;24(6):783-792. doi: 10.1177/1526602817725062. Epub 2017 Aug 10.

DOI:10.1177/1526602817725062

PMID:28795638

Abstract

PURPOSE

To report a randomized trial comparing the Legflow paclitaxel-eluting balloon (PEB) + Supera stenting to Supera stenting alone in patients with intermediate to long superficial femoral artery (SFA) lesions.

METHODS

The multicenter RAPID trial ( controlled-trials.com ; identifier ISRCTN47846578) randomized (1:1) 160 patients (mean age 67 years; 102 men) with Rutherford category 2-6 ischemia to treatment with Legflow PEB + Supera stent or Supera stent alone in intermediate to long SFA lesions (mean lesion length 15.8±7.4 vs 15.8±7.6 cm, respectively). The efficacy outcome was primary patency, defined as freedom from restenosis on duplex ultrasound or angiography.

RESULTS

Baseline characteristics including the percentage of occlusions were similar between groups. In the intention-to-treat analysis, the estimated primary patency at 1 year was 68.3% (95% CI 56.7% to 79.9%) in the PEB + Supera group vs 62.0% (95% CI 49.1% to 74.9%) in the Supera group (p=0.900). Per-protocol analysis showed a 12-month primary patency estimate of 74.7% (95% CI 63.1% to 86.3%) in the PEB + Supera group vs 62.0% (95% CI 49.1% to 74.9%) in the control group (p=0.273). Secondary patency estimates at 12 months (per-protocol analysis) were 89.0% (95% CI 80.6% to 97.4%) vs 98.0% (95% CI 94.1% to 100%; p=0.484); the estimates for freedom from clinically driven target lesion revascularization (CD-TLR) were 83.0% (95% CI 72.8% to 93.2%) and 77.8% (95% CI 66.6% to 89.0%; p=0.277), respectively.

CONCLUSION

The short-term results from the multicenter RAPID randomized controlled trial indicate that the Legflow PEB is safe and feasible for the treatment of intermediate to long SFA lesions. In this trial, at least 70% of the patients suffered an occlusion. The PEB group had higher rates of primary patency and freedom from CD-TLR, although there were no statistically significant differences vs controls.

摘要

目的

报告一项比较 Legflow 紫杉醇洗脱球囊（PEB）+Supera 支架与单纯 Supera 支架治疗中长段股浅动脉（SFA）病变的随机试验。

方法

多中心 RAPID 试验（controlled-trials.com；标识符 ISRCTN47846578）以 1:1 的比例随机分配 160 例（平均年龄 67 岁；102 例男性）Rutherford 分类 2-6 级缺血患者接受 Legflow PEB+Supera 支架或单纯 Supera 支架治疗中长段 SFA 病变（平均病变长度分别为 15.8±7.4cm 和 15.8±7.6cm）。主要疗效终点为通畅率，定义为经多普勒超声或血管造影检查无再狭窄。

结果

两组患者的基线特征，包括闭塞率，均相似。意向治疗分析显示，PEB+Supera 组 1 年通畅率为 68.3%（95%CI 56.7%至 79.9%），Supera 组为 62.0%（95%CI 49.1%至 74.9%）（p=0.900）。按方案分析显示，PEB+Supera 组 12 个月通畅率为 74.7%（95%CI 63.1%至 86.3%），对照组为 62.0%（95%CI 49.1%至 74.9%）（p=0.273）。12 个月时的次要通畅率（按方案分析）分别为 89.0%（95%CI 80.6%至 97.4%）和 98.0%（95%CI 94.1%至 100%；p=0.484）；无临床驱动的靶病变血运重建（CD-TLR）的估计值分别为 83.0%（95%CI 72.8%至 93.2%）和 77.8%（95%CI 66.6%至 89.0%；p=0.277）。