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

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).

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Fig. 1
Fig. 2

Abbreviations

FS:

= FemoSeal study arm

MC:

Manual Compression

PG:

ProGlide study arm

VCD:

Vascular Closure Device

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Acknowledgments

We would like to thank clinical research assistants Patrice Chauveau, Sandrine Renaud, and Julie Jaulin for their excellent technical support in monitoring data. Language editing of the first version of this manuscript was provided by Jason Miller of SQUID Translation, funded by the Center Hospitalier Universitaire de Nantes (Nantes teaching hospital).

Funding

This study was funded by a grant from the French Ministry of Health (PHRC-IR 2017-A00894-49; ref: RC16_0466). The funder of the study had no role in study design; data collection, analysis, or interpretation; or drafting of this report.

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Authors

Contributions

Dr. Gouëffic reports research funding from Bard, Medtronic, Terumo, and W.L. Gore; and personal fees and grants from Abbott, Bard, Biotronik, Boston Scientic, Medtronic, Terumo, Vygon, and W.L. Gore (modest). Dr. Schneider reports personal fees from W.L. Gore (modest). Dr. Kaladji reports personal fees from W.L. Gore (modest). Dr. Nasr reports personal fees from Medtronic, Biotronik, and W.L. Gore (modest). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Corresponding author

Correspondence to Bahaa Nasr.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study. Consent for publication was obtained for every individual person’s data included in the study.

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Gouëffic, Y., Picquet, J., Schneider, F. et al. A Randomized Trial Comparing Polymer Versus Suture-Based Vascular Closure Devices for Arterial Closure Following Lower-Limb Arterial Endovascular Revascularization. Cardiovasc Intervent Radiol (2021). https://doi.org/10.1007/s00270-021-02940-z

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Keywords

  • Vascular closure device
  • Peripheral arterial disease
  • Endovascular
  • FemoSeal
  • ProGlide