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Impact of Calcification on the Outcomes of Femoropopliteal Artery Endovascular Treatment Using a Polymer Coated Drug-Eluting Stent

  • Clinical Investigation
  • Arterial Interventions
  • Published:
CardioVascular and Interventional Radiology Aims and scope Submit manuscript

Abstract

Purpose

The aim of this study was to analyze the impact of calcification on the 12 and 24 months outcomes of the Eluvia™ (Boston Scientific®) drug-eluting stent (DES) for femoropopliteal occlusive disease using three different calcium scoring systems.

Material and Methods

A single-center, retrospective cohort-study (March-2016 to December-2018) of patients treated with the Eluvia™ DES for femoropopliteal atherosclerosis was performed. Outcomes included primary and secondary patency rates and freedom from target lesion revascularization (FTLR) and were analyzed by comparing the impact of calcium burden according to the following calcium scores: Peripheral Arterial Calcium Scoring System (PACSS) score, number of vessel quadrants affected (0–4) and calcification score per Peripheral Academic Research Consortium (PARC) definitions.

Results

In total, 111 Patients were included (mean age: 71.2 ± 7.9; 64% male). Most patients presented with Rutherford class 3 (79.9%), followed by class 5 (12.7%), class 4 (10%) and class 6 (6.4%). The mean lesion length was 197.6 ± 108.5 mm and 74.3% of patients had chronic total occlusions. There were no differences in primary patency between the calcification scores at 12 months (PACSS, LogRank = 0.28; quadrants, LogRank = 0.29; PARC, LogRank = 0.42) and 24 months (PACSS, LogRank = 0.13; quadrants, LogRank = 0.42; PARC, LogRank = 0.13). FTLR was significantly lower at 12 months in patients with calcification affecting 3 or 4 quadrants (LogRank = 0.022) but not at 24 months (LogRank = 0.36).

Conclusions

In this study, the Eluvia™ DES showed promising performance in calcified disease and the analysis according to the quadrant model predicted an increased risk for TLR at 12 months.

Graphical Abstract

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References

  1. Conte MS, Bradbury AW, Kolh P, White JV, Dick F, Fitridge R, et al. Global vascular guidelines on the management of chronic limb-threatening ischemia. Eur J Vasc Endovasc Surg. 2019;58(1):S1-109.

    Article  PubMed  PubMed Central  Google Scholar 

  2. Aboyans V, Ricco JB, Bartelink MEL, Björck M, Brodmann M, Cohnert T, et al. Editor’s choice—2017 esc guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the european society for vascular surgery (ESVS). Eur J Vasc Endovasc Surg. 2018;55:305–68.

    Article  PubMed  Google Scholar 

  3. Stavroulakis K, Borowski M, Torsello G, Bisdas T, CRITISCH Collaborators. One-year results of first-line treatment strategies in patients with critical limb ischemia (CRITISCH registry). J Endovasc Ther. 2018;25:320–9.

    Article  PubMed  Google Scholar 

  4. Bisdas T, Beropoulis E, Argyriou A, Torsello G, Stavroulakis K. 1-Year all-comers analysis of the Eluvia drug-eluting stent for long femoropopliteal lesions after suboptimal angioplasty. JACC Cardiovasc Interv. 2018;11(10):957–66.

    Article  PubMed  Google Scholar 

  5. Stavroulakis K, Torsello G, Bosiers M, Argyriou A, Tsilimparis N, Bisdas T. 2-Year outcomes of the Eluvia drug-eluting stent for the treatment of complex femoropopliteal lesions. JACC Cardiovasc Interv. 2021;14(6):692–701.

    Article  PubMed  Google Scholar 

  6. Gouëffic Y, Torsello G, Zeller T, Esposito G, Vermassen F, Hausegger KA, Tepe G, Thieme M, Gschwandtner M, Kahlberg A, Schindewolf M, Sapoval M, Diaz-Cartelle J, Stavroulakis K, EMINENT Investigators. Efficacy of a drug-eluting stent versus bare metal stents for symptomatic femoropopliteal peripheral artery disease: primary results of the EMINENT randomized trial. Circulation. 2022;146(21):1564–76.

    Article  PubMed  Google Scholar 

  7. Konijn LC, Takx RA, de Jong PA, Spreen MI, Veger HT, Mali WP, van Overhagen H. Arterial calcification and long-term outcome in chronic limb-threatening ischemia patients. Eur J Radiol. 2020;132: 109305.

    Article  PubMed  Google Scholar 

  8. He HP, Weng JC, Zhao Y, Cai SH, Zhang XL, Yin HH. Impact of plaque calcification and stent oversizing on clinical outcomes of atherosclerotic femoropopliteal arterial occlusive disease following stent angioplasty. Eur J Vasc Endovasc Surg. 2019;58(2):215–22.

    Article  PubMed  Google Scholar 

  9. Tokuda T, Oba Y, Koshida R, Suzuki Y, Murata A, Ito T. The impact of femoropopliteal artery calcium score after endovascular treatment. Ann Vasc Surg. 2020;66:543–53.

    Article  PubMed  Google Scholar 

  10. Patel MR, Conte MS, Cutlip DE, Dib N, Geraghty P, Gray W, et al. Evaluation and treatment of patients with lower extremity peripheral artery disease: consensus definitions from Peripheral Academic Research Consortium (PARC). J Am Coll Cardiol. 2015;65(9):931–41.

    Article  PubMed  PubMed Central  Google Scholar 

  11. Konijn LCD, van Overhagen H, Takx RAP, de Jong PA, Veger HTC, Mali WPTM. CT calcification patterns of peripheral arteries in patients without known peripheral arterial disease. Eur J Radiol. 2020;128: 108973.

    Article  PubMed  Google Scholar 

  12. Müller-Hülsbeck S, Benko A, Soga Y, Fujihara M, Iida O, Babaev A, O’Connor D, Zeller T, Dulas DD, Diaz-Cartelle J, Gray WA. Two-year efficacy and safety results from the IMPERIAL randomized study of the Eluvia polymer-coated drug-eluting stent and the Zilver PTX polymer-free drug-coated stent. Cardiovasc Interv Radiol. 2021;44(3):368–75.

    Article  Google Scholar 

  13. von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP, STROBE Initiative. The strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. Int J Surg. 2014;12:1495–9.

    Article  Google Scholar 

  14. Rocha-Singh KJ, Zeller T, Jaff MR. Peripheral arterial calcification: prevalence, mechanism, detection, and clinical implications. Catheter Cardiovasc Interv. 2014;83:E212–20.

    Article  PubMed  Google Scholar 

  15. Okuno S, Iida O, Shiraki T, Fujita M, Masuda M, Okamoto S, et al. Impact of calcification on clinical outcomes after endovascular therapy for superficial femoral artery disease: assessment using the peripheral artery calcification scoring system. J Endovasc Ther. 2016;23:731–7.

    Article  PubMed  Google Scholar 

  16. Stavroulakis K, Bisdas T, Torsello G, Tsilimparis N, Damerau S, Argyriou A. Intravascular Lithotripsy and drug-coated balloon angioplasty for severely calcified femoropopliteal arterial disease. J Endovasc Ther. 2022;7:15266028221075564.

    Google Scholar 

  17. Fanelli F, Cannavale A, Gazzetti M, Lucatelli P, Wlderk A, Cirelli C, et al. Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease. Cardiovasc Interv Radiol. 2014;37:898–907.

    Article  CAS  Google Scholar 

  18. Kum S, Ipema J, Huizing E, Tan YK, Lim D, Lok IY, et al. Outcomes of the paclitaxel-eluting Eluvia stent for long femoropopliteal lesions in Asian patients with predominantly chronic limb-threatening ischemia. Vasc Med. 2021;26:267–72.

    Article  CAS  PubMed  Google Scholar 

  19. Iida O, Takahara M, Soga Y, Yamaoka T, Fujihara M, Kawasaki D, et al. 1-Year outcomes of fluoropolymer-based drug-eluting stent in femoropopliteal practice: predictors of restenosis and aneurysmal degeneration. JACC Cardiovasc Interv. 2022;15:630–8.

    Article  PubMed  Google Scholar 

  20. Golzar J, Soga Y, Babaev A, Iida O, Kawasaki D, Bachinsky W, et al. Effectiveness and safety of a paclitaxel-eluting stent for superficial femoral artery lesions up to 190 mm: one-year outcomes of the single-arm IMPERIAL long lesion substudy of the Eluvia drug-eluting stent. J Endovasc Ther. 2020;27:296–303.

    Article  PubMed  Google Scholar 

  21. Shehada Y, Bisdas T, Argyriou A, Torsello G, Tsilimparis N, Beropoulis E, Stavroulakis K. Efficacy analysis following polymer coated drug eluting stent and bare metal stent deployment for femoropopliteal arterial disease. Vascular. 2022;7:17085381221126216.

    Google Scholar 

  22. Iida O, Fujihara M, Kawasaki D, Mori S, Yokoi H, Miyamoto A, Kichikawa K, Nakamura M, Ohki T, Diaz-Cartelle J, Müller-Hülsbeck S, Gray WA, Soga Y. 24-Month efficacy and safety results from Japanese patients in the imperial randomized study of the Eluvia drug-eluting stent and the zilver ptx drug-coated stent. Cardiovasc Interv Radiol. 2021;44(9):1367–74.

    Article  Google Scholar 

  23. Gray WA, Griffiths RI, Elroy PWM, Amorosi SL, McGovern AM, Jaff MR, et al. Cost-effectiveness of a paclitaxel-eluting stent (Eluvia) compared to Zilver PTX for endovascular femoropopliteal intervention. J Med Econ. 2022;25:880–7.

    Article  PubMed  Google Scholar 

  24. Ichihashi S, Takahara M, Yamaoka T, Hara M, Kobayashi T, Tamai H, et al. Drug eluting versus covered stent for femoropopliteal artery lesions: results of the ULTIMATE study. Eur J Vasc Endovasc Surg. 2022;S1078–5884(22):00348–53.

    Google Scholar 

  25. Dias-Neto M, Matschuck M, Bausback Y, Banning-Eichenseher U, Steiner S, et al. Endovascular treatment of severely calcified femoropopliteal lesions using the “pave-and-crack” technique: technical description and 12-month results. J Endovasc Ther. 2018;25:334–42.

    Article  PubMed  Google Scholar 

  26. Fujihara M, Kozuki A, Tsubakimoto Y, Takahara M, Shintani Y, Fukunaga M, et al. Lumen gain after endovascular therapy in calcified superficial femoral artery occlusive disease assessed by intravascular ultrasound (code study). J Endovasc Ther. 2019;26:322–30.

    Article  PubMed  Google Scholar 

  27. Ichihashi S, Shibata T, Fujimura N, Nagatomi S, Yamamoto H, Kyuragi R, Adachi A, Iwakoshi S, Bolstad F, Saeki K, Obayashi K, Kichikawa K. Vessel calcification as a risk factor for in-stent restenosis in complex femoropopliteal lesions after Zilver PTX paclitaxel-coated stent placement. J Endovasc Ther. 2019;26(5):613–20.

    Article  PubMed  Google Scholar 

  28. Mori S, Takahara M, Nakama T, Tobita K, Hayakawa N, Iwata Y, Horie K, Suzuki K, Yamawaki M, Ito Y. Impact of calcification on clinical outcomes after drug-coated balloon angioplasty for superficial femoral artery disease: assessment using the peripheral artery calcification scoring system. Catheter Cardiovasc Interv. 2023;101(5):892–9.

    Article  PubMed  Google Scholar 

  29. Bernardini G, Bisdas T, Argyriou A, Saab F, Torsello G, Tsilimparis N, Stavroulakis K. Risk factor analysis for crossing failure in primary antegrade wire-catheter approach for femoropopliteal chronic total occlusions. J Endovasc Ther. 2023;30(3):433–40.

    Article  PubMed  Google Scholar 

  30. Maehara A, Mintz GS, Shimshak TM, Ricotta JJ 2nd, Ramaiah V, Foster MT 3rd, et al. Intravascular ultrasound evaluation of JETSTREAM atherectomy removal of superficial calcium in peripheral arteries. EuroIntervention. 2015;11:96–103.

    Article  PubMed  Google Scholar 

  31. Yin D, Maehara A, Shimshak TM, Ricotta JJ 2nd, Ramaiah V, Foster MT 3rd. Intravascular ultrasound validation of contemporary angiographic scores evaluating the severity of calcification in peripheral arteries. J Endovasc Ther. 2017;24:478–87.

    Article  PubMed  Google Scholar 

  32. Stavroulakis K, Argyriou A, Watts M, Varghese JJ, Estes BA, Torsello G, et al. How to deal with calcium in the superficial femoral artery. J Cardiovasc Surg (Torino). 2019;60:572–81.

    PubMed  Google Scholar 

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Acknowledgements

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Funding

The authors state there was no funding for the present study.

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Authors and Affiliations

  1. Vascular Surgery Department, Ludwig Maximilian University Hospital, Campus Grosshadern, Marchioninistrasse 15, 81377, Munich, Germany

    Ryan Gouveia e Melo, Nikolaos Tsilimparis & Konstantinos Stavroulakis

  2. Department of Vascular Surgery, St. Franziskus-Hospital GmbH, Münster, Germany

    Giovanni Torsello, Theodosios Bisdas & Efthymios Beropoulis

  3. Department of Vascular and Endovascular Surgery, Marien Hospital, Herne, Germany

    Angeliki Argyriou

  4. Division of Biostatistics, School of Medicine, University of Heraklion, Heraklion, Greece

    Gregory Chlouverakis

  5. Department of Vascular and Endovascular Surgery, Athens Medical Center, Athens, Greece

    Theodosios Bisdas

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  1. Ryan Gouveia e Melo
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Corresponding author

Correspondence to Ryan Gouveia e Melo.

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Conflicts of interest

Konstantinos Stavroulakis—Consulting for Phillips, Shockwave, Boston Scientific, Terumo and received Honoraria from Medtronic, Bentley, Abbott and Biotronik; Giovanni Torsello—consulting for Medtronic, Boston Scientific and received grants from Medtronic, Gore, Cook and Cordis; Theodosios Bisdas—Consulting for Boston Scientific, Medtronic, BARD and COOK Medical and Nikolaos Tsilimparis—Proctor for and has received institutional Research funding from Cook Medical. All remaining authors declare no conflict of interest.

Ethical Approval

Ethical approval was obtained from St. Franziskus-Hospital GmbH, Muenster, Germany—Reference number- N:2021-2020-f-S.

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All patients signed the informed consent for both the procedures and publication of the outcomes data.

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Gouveia e Melo, R., Torsello, G., Argyriou, A. et al. Impact of Calcification on the Outcomes of Femoropopliteal Artery Endovascular Treatment Using a Polymer Coated Drug-Eluting Stent. Cardiovasc Intervent Radiol 47, 543–553 (2024). https://doi.org/10.1007/s00270-024-03662-8

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