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

doi:10.1007/s00270-021-02940-z

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 Picquet³, Fabrice Schneider⁴, Adrien Kaladji⁵, Olivier Marret⁶, Laurent Muller⁷, Béatrice Guyomarc'h⁸, Valéry-Pierre Riche⁹, Philippe Chaillou¹⁰, Marie Guillou¹⁰, Bahaa Nasr^{11

12}

Affiliations

¹ Department of Vascular and Endovascular Surgery, Paris Saint Joseph Hospital, Paris, France.
² Laboratoire de Physiopathologie de La Résorption Osseuse, INSERM-UN UMR 957, Nantes, France.
³ Department of Vascular Surgery, Angers University Hospital, Angers, France.
⁴ Department of Vascular Surgery, Poitiers University Hospital, Poitiers, France.
⁵ Department of Cardiovascular and Thoracic Surgery, Rennes University Hospital, Rennes, France.
⁶ Department of Vascular Surgery, La Roche-sur-Yon Hospital, La Roche-sur-Yon, France.
⁷ Department of Vascular Surgery, Cholet Hospital, Cholet, France.
⁸ Institut du Thorax, Nantes University Hospital/INSERM/CNRS/Nantes University, Nantes, France.
⁹ Division of Health Product Development and Economic Evaluation, Department of Partnerships and Innovation, Nantes University Hospital, Nantes, France.
¹⁰ Department of Vascular Surgery, Institut du Thorax, Nantes University Hospital, Nantes, France.
¹¹ Department of Vascular Surgery, Brest University Hospital, Brest, France. nasr.bahaa@gmail.com.
¹² Service de Chirurgie Vasculaire, CHU Brest, 29200, Brest, France. nasr.bahaa@gmail.com.

PMID: 34386892
DOI: 10.1007/s00270-021-02940-z

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.

. 2021 Dec;44(12):1883-1892.

doi: 10.1007/s00270-021-02940-z. Epub 2021 Aug 13.

Authors

Affiliations

¹ Department of Vascular and Endovascular Surgery, Paris Saint Joseph Hospital, Paris, France.
² Laboratoire de Physiopathologie de La Résorption Osseuse, INSERM-UN UMR 957, Nantes, France.
³ Department of Vascular Surgery, Angers University Hospital, Angers, France.
⁴ Department of Vascular Surgery, Poitiers University Hospital, Poitiers, France.
⁵ Department of Cardiovascular and Thoracic Surgery, Rennes University Hospital, Rennes, France.
⁶ Department of Vascular Surgery, La Roche-sur-Yon Hospital, La Roche-sur-Yon, France.
⁷ Department of Vascular Surgery, Cholet Hospital, Cholet, France.
⁸ Institut du Thorax, Nantes University Hospital/INSERM/CNRS/Nantes University, Nantes, France.
⁹ Division of Health Product Development and Economic Evaluation, Department of Partnerships and Innovation, Nantes University Hospital, Nantes, France.
¹⁰ Department of Vascular Surgery, Institut du Thorax, Nantes University Hospital, Nantes, France.
¹¹ Department of Vascular Surgery, Brest University Hospital, Brest, France. nasr.bahaa@gmail.com.
¹² Service de Chirurgie Vasculaire, CHU Brest, 29200, Brest, France. nasr.bahaa@gmail.com.

PMID: 34386892
DOI: 10.1007/s00270-021-02940-z

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

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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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[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

[2] 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

[3] 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

[4] 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

[5] 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

[6] 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

[7] 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

[8] 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

[9] 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

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

Affiliations

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

Authors

Affiliations

Abstract

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Cited by

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LinkOut - more resources

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Medical

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