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Prognostic risk factors for loss of patency after femoropopliteal bailout stenting with dual-component stent: results from the TIGRIS Italian Multicenter Registry

  • Vascular and Interventional Radiology
  • Published:
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Abstract

Purpose

To identify the risk factors associated with patency loss after bailout stenting with third-generation hybrid heparin-bonded nitinol stent of the femoropopliteal segment.

Methods

Prospective, multicenter, single-arm registry including 156 patients (50 females, mean age 72 ± 11 years) subjected, from February 2017 to December 2018, to provisional stenting with Gore Tigris vascular stent of the distal superficial femoral artery, with or without involvement of the popliteal artery, in 9 different centers. The 194 lesions, with Rutherford score ≥ 3, were stented in case of recoil, dissection or residual stenosis not responding to percutaneous trans-luminal angioplasty (PTA). The follow-up (FU) was performed with clinical evaluation and duplex ultrasound (DUS) at 1, 6 and 12 months.

Results

The primary patency rate was 99(95%CI 98–100)% at 1 month, 86(80–92)% at 6 months and 81(74–88)% at-12 months. After patency loss, 13/23 (56.5%) patients were re-treated, yielding a primary assisted patency of 91(86–96)% at 6 months and 88(82–94)% at 12 months and a secondary patency of 94(90–98)% at 6 months and 90(84–95)% at 12 months. Rutherford score ≥ 4 (p = 0.03) and previous severe treatments (p = 0.01) were identified as risk factors for early patency loss during FU. The involvement of the popliteal artery was not an independent risk factor for loss of patency.

Conclusions

The bailout stenting of the femoropopliteal segment with third-generation nitinol stents is a safe and effective option in case of recoil, dissection or residual stenosis not responding to PTA. Critical limb ischemia and history of previous major treatment at the same level are significant prognostic factors for patency loss during FU.

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Availability of data and material

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

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Funding

This study was not supported by any funding.

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Authors and Affiliations

  1. Department of Diagnostic Imaging and Radiotherapy, Vascular Radiology, A.O.U. Città Della Salute e Della Scienza di Torino, Corso Bramante 88, Turin, Italy

    Maria Antonella Ruffino

  2. Radiology Unit, Department of Surgical Sciences, A.O.U. Città Della Salute e Della Scienza di Torino, Via Genova 3, Turin, Italy

    Marco Fronda, Sara Varello & Paolo Fonio

  3. Department of Surgical Sciences, University of Turin-A.O.U. Città della Salute e della Scienza di Torino, Via Genova 3, Turin, Italy

    Laura Bergamasco

  4. Department of Diagnostic and Interventional Radiology, Interventional Radiology, U. Parini Hospital, Via Ginevra 3, Aosta, Italy

    Massimiliano Natrella & Gianluca Fanelli

  5. Cardiovascular Department, Vascular and Endovascular Surgery, Poliambulanza Foundation Hospital, Via Bissolati 57, Brescia, Italy

    Raffaello Bellosta, Matteo Pegorer & Luca Attisani

  6. Endovascular Surgery-Vascular Surgery Unit, ASL BR1-Ospedale “A. Perrino”, Strada per lo Spada 5, Brindisi, Italy

    Massimo Ruggiero

  7. UOC Diagnostic Imaging and Interventional Radiology, A.O. Per L’emergenza “Cannizzaro“, Via Messina 829, Catania, Italy

    Pierantonio Malfa & Domenico Patane’

  8. Department of Radiological Oncological and Anatomo-Pathological Sciences, Vascular and Interventional Radiology, Sapienza University of Rome, Viale del Policlinico 155, Roma, Italy

    Pierleone Lucatelli & Mario Corona

  9. Interventional Radiology Unit, Radiology Department, A.O.U. Senese, Viale Bracci 16, Siena, Italy

    Carmelo Ricci & Laura Candeloro

  10. S.C. Vascular and Endovascular Surgery, Ospedale Umberto I, Largo Filippo Turati 62, Turin, Italy

    Michelangelo Ferri

  11. Vascular Surgery Unit, Department of Surgical Sciences, University of Torino-A.O.U. Città Della Salute E Della Scienza Di Torino, Corso Bramante 88, Turin, Italy

    Lorenzo Gibello

  12. Department of Vascular Surgery, Integrated University Hospital of Verona, Piazzale Aristide Stefani 1, Verona, Italy

    Gian Franco Veraldi & Luca Mezzetto

Authors
  1. Maria Antonella Ruffino
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  2. Marco Fronda
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  3. Laura Bergamasco
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  4. Massimiliano Natrella
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  12. Pierleone Lucatelli
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  14. Carmelo Ricci
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  15. Laura Candeloro
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  16. Michelangelo Ferri
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  17. Sara Varello
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  18. Lorenzo Gibello
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  19. Gian Franco Veraldi
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  20. Luca Mezzetto
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  21. Paolo Fonio
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Corresponding author

Correspondence to Marco Fronda.

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Conflict of interest

The authors declare that they have no conflict of interest.

Ethics approval

The study was approved by the local Ethics Committee of all participating centers (protocol number of the site principal investigator: 0038779). 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.

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Consent for publication was obtained for every individual person’s data included in the study.

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Ruffino, M.A., Fronda, M., Bergamasco, L. et al. Prognostic risk factors for loss of patency after femoropopliteal bailout stenting with dual-component stent: results from the TIGRIS Italian Multicenter Registry. Radiol med 126, 1129–1137 (2021). https://doi.org/10.1007/s11547-021-01373-5

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  • DOI: https://doi.org/10.1007/s11547-021-01373-5

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