A Randomized Trial Comparing Polymer Versus Suture-Based Vascular Closure Devices for Arterial Closure Following Lower-Limb Arterial Endovascular Revascularization.

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 https://ClinicalTrials.gov (NCT03192033).