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Published on: October 26, 2019
A Randomized Trial Comparing Polymer Versus Suture-Based Vascular Closure Devices for Arterial Closure Following
Yann Gouëffic1,2, Jean Picquet3, Fabrice Schneider4
1Department of Vascular and Endovascular Surgery, Paris Saint Joseph Hospital, Paris, France.
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).
