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Randomized Controlled Trial
. 2021 Dec;44(12):1883-1892.
doi: 10.1007/s00270-021-02940-z. Epub 2021 Aug 13.

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

Yann Gouëffic  1   2 , Jean Picquet  3 , Fabrice Schneider  4 , Adrien Kaladji  5 , Olivier Marret  6 , Laurent Muller  7 , Béatrice Guyomarc'h  8 , Valéry-Pierre Riche  9 , Philippe Chaillou  10 , Marie Guillou  10 , Bahaa Nasr  11   12
Affiliations
Randomized Controlled Trial

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

Yann Gouëffic et al. Cardiovasc Intervent Radiol. 2021 Dec.

Abstract

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).

Keywords: Endovascular; FemoSeal; Peripheral arterial disease; ProGlide; Vascular closure device.

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References

    1. Hvelplund A, Galatius S, Madsen M, Rasmussen JN, Sorensen R, Fosbol EL, et al. Influence of distance from home to invasive centre on invasive treatment after acute coronary syndrome: a nationwide study of 24 910 patients. Heart. 2011;97(1):27–32. https://doi.org/10.1136/hrt.2010.203901 . - DOI - PubMed
    1. Steffenino G, Dellavalle A, Ribichini F, Russo P, Conte L, Dutto S, et al. Ambulation three hours after elective cardiac catheterisation through the femoral artery. Heart. 1996;75(5):477–80. https://doi.org/10.1136/hrt.75.5.477 . - DOI - PubMed - PMC
    1. Ward SR, Casale P, Raymond R, Kussmaul WG 3rd, Simpfendorfer C. Efficacy and safety of a hemostatic puncture closure device with early ambulation after coronary angiography. Angio-Seal Invest Am J Cardiol. 1998;81(5):569–72. https://doi.org/10.1016/s0002-9149(97)00970-3 . - DOI
    1. Burns P, Gough S, Bradbury AW. Management of peripheral arterial disease in primary care. BMJ. 2003;326(7389):584–8. https://doi.org/10.1136/bmj.326.7389.584 . - DOI - PubMed - PMC
    1. Noori VJ, Eldrup-Jorgensen J. A systematic review of vascular closure devices for femoral artery puncture sites. J Vasc Surg. 2018;68(3):887–99. https://doi.org/10.1016/j.jvs.2018.05.019 . - DOI - PubMed

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