Purposes

The primary objective of this study (STEP trial) was to compare the efficacy of the polymer-based FemoSeal® vascular closure device (VCD) and the suture-based ProGlide® VCD in achieving hemostasis at the femoral access site after lower-limb arterial endovascular revascularization.

Materials and Methods

STEP was a multicenter randomized clinical trial including patients undergoing lower-limb arterial endovascular revascularization. The primary endpoint was technical success 5 h after the VCD intervention, defined as achievement of hemostasis without the need for a follow-up intervention at the access site and without a 2-g/dL drop in hemoglobin.

Results

Between December 2017 and April 2019, 113 patients were assigned to the FemoSeal® group (FS) and 117 to the ProGlide® group (PG). VCD interventions were technically successful for 90 FS patients (80%) and 58 PG patients (50%) (odds ratio, 3.98; 95% CI, 2.22 to 7.14; p < 0.0001). This difference in success rates between FS and PG is partly explained by more frequent recourse to manual compression (FS: n = 19; PG: n = 45) and an additional VCD (FS: n = 0; PG: n = 23) in the latter group. After 5 h, 87% of FS patients and 69% of PG patients resumed ambulation (odds ratio: 3.07; 95% CI: 1.93 to 6.15; p = 0.0016).

Conclusions

In patients undergoing lower-limb arterial endovascular revascularization, FemoSeal® was superior to ProGlide® in terms of technical success.

Clinical Trial Registration

Step trial was registered on http://ClinicalTrials.gov (NCT03192033).

中文翻译：

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一项随机试验比较聚合物与基于缝合的血管闭合装置在下肢动脉血管内血运重建术后动脉闭合

目的

本研究（STEP 试验）的主要目的是比较基于聚合物的 FemoSeal® 血管闭合装置 (VCD) 和基于缝合线的 ProGlide® VCD 在下肢动脉血管内介入术后实现股骨通路部位止血的功效血运重建。

材料和方法

STEP 是一项多中心随机临床试验，包括接受下肢动脉血管内血运重建术的患者。主要终点是 VCD 干预后 5 小时的技术成功，定义为无需在进入部位进行后续干预且血红蛋白不下降 2 g/dL 即可实现止血。

结果

2017 年 12 月至 2019 年 4 月期间，113 名患者被分配到 FemoSeal®组 (FS)，117 名患者被分配到 ProGlide®组 (PG)。VCD 干预对 90 名 FS 患者（80%）和 58 名 PG 患者（50%）在技术上是成功的（优势比，3.98；95% CI，2.22 至 7.14；p  < 0.0001）。FS 和 PG 之间成功率的差异部分是由于更频繁地求助于手动压缩（FS：n  = 19；PG：n  = 45）和额外的 VCD（FS：n  = 0；PG：n  = 23）后一组。5 小时后，87% 的 FS 患者和 69% 的 PG 患者恢复下地活动（比值比：3.07；95% CI：1.93 至 6.15；p  = 0.0016）。

结论

在接受下肢动脉血管内血运重建术的患者中，FemoSeal® 在技术成功方面优于 ProGlide®。

临床试验注册

分步试验在 http://ClinicalTrials.gov (NCT03192033) 上注册。