BIOLUX P-III Passeo-18 Lux All-Comers Registry: 24-Month Results in Below-the-Knee Arteries

Abstract

Purpose

The BIOLUX P-III registry was initiated to further assess the safety and efficacy of the Passeo-18 Lux drug-coated balloon (DCB) in infrainguinal lesions in a real-world environment and in prespecified risk groups.

Materials and methods

BIOLUX P-III is a prospective, global, all-comers registry with patients treated under real-world conditions. We herein report 24-month results of the prespecified subgroup of 151 patients with 185 below-the-knee (BTK) lesions. The primary safety and efficacy endpoints were freedom from major adverse events (a composite of freedom from device and procedure mortality through 30 days, major target limb amputation and clinically driven target lesion revascularization) at 6 months and freedom from clinically driven target lesion revascularization (FfTLR) at 12 months.

Results

At baseline, 76.0% of patients had critical limb ischemia and 48.9% of lesions were TASC C or D lesions. Technical success was achieved in 97.8%, and bailout stenting was required in 1.1%. Freedom from major adverse events was 86.2% [95% CI 79.4; 90.8] at 6 months, and FfTLR was 90.9% [95% CI 85.2; 94.4] at 12 months. At 24 months, FfTLR was 90.9% [95% CI 85.2; 94.4], freedom from major amputation was 90.1% [95% CI 83.9, 94.0], and overall survival was 79.2% [70.7, 85.5]. There was a significant clinical improvement (mean Rutherford class improvement of − 2.9 ± 1.9, p < 0.0001) and an improvement in pain (mean improvement on Wong–Baker Faces Pain Scale of − 2.7 ± 2.9, p < 0.0001).

Conclusions

In this real-world DCB registry, 24-month outcomes of Passeo-18 Lux demonstrated safety and efficacy in BTK lesions with high patency rates and sustained clinical improvements at 24 months.

Trial Registration

NCT02276313

This is a preview of subscription content, access via your institution.

Fig. 1
Fig. 2
Fig. 3

Availability of Data and Material

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

References

  1. 1.

    Patel SD, Biasi L, Paraskevopoulos I, Silickas J, Lea T, Diamantopoulos A, Katsanos K, Zayed H. Comparison of angioplasty and bypass surgery for critical limb ischaemia in patients with infrapopliteal peripheral artery disease. Br J Surg. 2016;103:1815–22.

    CAS  Article  Google Scholar 

  2. 2.

    Kayssi A, Al-Atassi T, Oreopoulos G, Roche-Nagle G, Tan KT, Rajan DK. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2016. https://doi.org/10.1002/14651858.CD011319.pub2.

    Article  PubMed  Google Scholar 

  3. 3.

    Zhou Y, Lin S, Zhang Z, Xiao J, Ai W, Wang J, Li Y, Li Q. A network meta-analysis of randomized controlled trials comparing treatment modalities for infrapopliteal lesions in critical limb ischemia. Ann Vasc Surg. 2019;60:424–34.

    Article  Google Scholar 

  4. 4.

    Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Paraskevopoulos I, Karnabatidis D. Risk of death and amputation with use of paclitaxel-coated balloons in the infrapopliteal arteries for treatment of critical limb ischemia: a systematic review and meta-analysis of randomized controlled trials. J Vasc Interv Radiol. 2020;31:202–12.

    Article  Google Scholar 

  5. 5.

    Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D. Risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg: a systematic review and meta-analysis of randomized controlled trials. J Am Heart Assoc. 2018. https://doi.org/10.1161/JAHA.118.011245.

    Article  PubMed  PubMed Central  Google Scholar 

  6. 6.

    Freisinger E, Koeppe J, Gerss J, Goerlich D, Malyar NM, Marschall U, Faldum A, Reinecke H. Mortality after use of paclitaxel-based devices in peripheral arteries: a real-world safety analysis. Eur Heart J. 2019. https://doi.org/10.1093/eurheartj/ehz698.

    Article  PubMed Central  Google Scholar 

  7. 7.

    Zeller T, Beschorner U, Pilger E, Bosiers M, Deloose K, Peeters P, Scheinert D, Schulte KL, Rastan A, Brodmann M. Paclitaxel-coated balloon in infrapopliteal arteries. 12-month results from the BIOLUX P-II randomized trial (BIOTRONIK'S-first in man study of the Passeo-18 LUX drug releasing PTA balloon catheter vs. the uncoated Passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries). JACC Cardiovasc Interv. 2015;8:1614–22.

    Article  Google Scholar 

  8. 8.

    Scheinert D, Schulte KL, Zeller T, Lammer J, Tepe G. Paclitaxel-releasing balloon in femoropopliteal lesions using a BTHC excipient. Twelve-month results from the BIOLUX P-I randomized Trial. J. Endovasc. Ther. 2015;22:14–211.

    Article  Google Scholar 

  9. 9.

    Tepe G, Zeller T, Moscovic M, Corpataux JM, Christensen JK, Keirse K, Nano G, Schroeder H, Binkert CA, Brodmann M. Paclitaxel-coated balloon for the treatment of infrainguinal disease: 12-month outcomes in the all-comers cohort of BIOLUX P-III global registry. J Endovasc Ther. 2020;27:304–15.

    Article  Google Scholar 

  10. 10.

    Colleran R, Joner M, Kufner S, Altevogt F, Neumann FJ, Abdel-Wahab M, Bohner J, Valina C, Richardt G, Zrenner B, Cassese S, Ibrahim T, Laugwitz KL, Schunkert H, Kastrati A, Byrne RA. Intracoronary stenting and angiographic results: optimizing treatment of drug eluting stent in-stent restenosis 3 and 4 (ISAR-DESIRE 3 and ISAR-DESIRE 4) investigators. Comparative efficacy of two paclitaxel-coated balloons with different excipient coatings in patients with coronary in-stent restenosis: a pooled analysis of the Intracoronary stenting and angiographic results: optimizing treatment of drug eluting stent in-stent restenosis 3 and 4 (ISAR-DESIRE 3 and ISAR-DESIRE 4) trials. Int J Cardiol. 2018;252:57–62.

    Article  Google Scholar 

  11. 11.

    Mustapha JA, Brodmann M, Geraghty PJ, Saab F, Settlage RA, Jaff MR. Lutonix BTK study investigators. Drug-coated vs uncoated percutaneous transluminal angioplasty in infrapopliteal arteries: six-month results of the Lutonix BTK trial. J Invasive Cardiol. 2019;31:205–11.

    PubMed  Google Scholar 

  12. 12.

    Mehrotra S, Paramasivam G, Mishra S. Paclitaxel-coated balloon for femoropopliteal artery disease. Curr Cardiol Rep. 2017;2017(19):10. https://doi.org/10.1007/s11886-017-0823-4.

    Article  Google Scholar 

  13. 13.

    Blessing E, Lugenbiel I, Holden A. The evidence to support the use of focal force balloon technology to improve outcomes in the treatment of lower extremity arterial occlusive disease. J Cardiovasc Surg (Torino). 2019;60:14–20.

    Google Scholar 

  14. 14.

    Bunte MC, Shishehbor MH. Next generation endovascular therapies in peripheral artery disease. Prog Cardiovasc Dis. 2018;60:593–9.

    Article  Google Scholar 

  15. 15.

    Aboyans V, Ricco JB, Bartelink MEL, Björck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debus S, Espinola-Klein C, Kahan T, Kownator S, Mazzolai L, Naylor AR, Roffi M, Röther J, Sprynger M, Tendera M, Tepe G, Venermo M, Vlachopoulos C, Desormais I, ESC Scientific Document Group. 2017 ESC Guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European Society for Vascular Surgery (ESVS): document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European Stroke Organization (ESO) the task force for the diagnosis and treatment of peripheral arterial diseases of the European Society of Cardiology (ESC) and of the European Society for vascular surgery (ESVS). Eur Heart J. 2018;39:763–816.

    Article  Google Scholar 

  16. 16.

    Herten M, Torsello GB, Schönefeld E, Stahlhoff S. Critical appraisal of paclitaxel balloon angioplasty for femoral-popliteal arterial disease. Vasc Health Risk Manag. 2016;12:341–56.

    CAS  Article  Google Scholar 

  17. 17.

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

    CAS  Article  Google Scholar 

  18. 18.

    Liistro F, Porto I, Angioli P, Grotti S, Ricci L, Ducci K, Falsini G, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Drug-eluting balloon in peripheral intervention for below the knee angioplasty evaluation (DEBATE-BTK): a randomized trial in diabetic patients with critical limb ischemia. Circulation. 2013;128:615–21.

    CAS  Article  Google Scholar 

  19. 19.

    Teichgräber U, Lehmann T, Thieme M, Wahl KU, Stelzner C, Bormann A, Götz L, Kroeßner T, Boden H, Maiwald L, Aschenbach R. Drug-coated balloon angioplasty of infrapopliteal lesions in patients with critical limb ischaemia: 1-year results of the APOLLO trial. Cardiovasc Interv Radiol. 2019;42:1380–90.

    Article  Google Scholar 

  20. 20.

    Zeller T, Baumgartner I, Scheinert D, Brodmann M, Bosiers M, Micari A, Peeters P, Vermassen F, Landini M, Snead DB, Kent KC, IN.PACT DEEP trial investigators. Drug-eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: 12-month results from the IN.PACT DEEP randomized trial. J Am Coll Cardiol. 2014;64:1568–76.

    Article  Google Scholar 

  21. 21.

    Lichtenberg M, Scheinert D. LUTONIX® DCB Interim 24 month outcomes from global BTK registry. LINC 2019. Accessed 10 July 2019.

  22. 22.

    Lichtenberg M, Scheinert D. Initial look at the global Lutonix DCB BTK registry study 12 month interim outcomes. Lutonix DCB BTK registry study. LINC 2019. Accessed 10 July 2019.

  23. 23.

    Conte MS, Geraghty PJ, Bradbury AW, Hevelone ND, Lipsitz SR, Moneta GL, Nehler MR, Powell RJ, Sidawy AN. Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemiae1-3. J Vasc Surg. 2009;50:1462–73.

    Article  Google Scholar 

  24. 24.

    Mustapha JA, Katzen BT, Neville RF, et al. Disease burden and clinical outcomes following initial diagnosis of critical limb ischemia in the Medicare population. JACC Cardiovasc Interv. 2018;11:1011–2.

    Article  Google Scholar 

  25. 25.

    Reinecke H, Unrath M, Freisinger E, et al. Peripheral arterial disease and critical limb ischaemia: still poor outcomes and lack of guideline adherence. Eur Heart J. 2015;36:932–8.

    Article  Google Scholar 

Download references

Acknowledgements

We thank Beatrix Doerr for her assistance in preparing this manuscript, reimbursed by BIOTRONIK AG.

Funding

This study was funded by BIOTRONIK AG, Buelach, Switzerland. The sponsor was involved in the design of the study, data collection and data analysis.

Author information

Affiliations

Authors

Contributions

GT wrote the paper. All other authors were involved in data collection and entry, critically reviewed the manuscript and provided approval of its current version.

Corresponding author

Correspondence to Gunnar Tepe.

Ethics declarations

Conflict of interest

All authors are clinical investigators of the BIOLUX P-III registry. Gunnar Tepe reports study support by B. Braun, BARD, Bayer, Biotronik, BSC, Gore, Medtronic, Phillips, Verian. Marianne Brodmann receives honoraria from Abbott Vascular, Biotronik, Philips-Spectranetics, Medtronic, Daiichi Sankyo, Bayer Healthcare and BD Bard, acts as a consultant for Boston Scientific Corp., Medtronic, Spectranetics, Intact Vascular, Shockwave, Bayer, Vesper Medical and BD Bard, and receives study support by 480 biomedical, BD Bard, Biotronik, Medtronic, Philips, Shockwave, Med Alliance, Intact Vascular and B. Braun. Christoph Binkert acts as a consultant for Merit Medical and receives research support by Philips/ Profound and Abbott. The other authors declare that they have no conflict of interest.

Ethics Approval

All procedures performed 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.

Informed Consent

Informed consent was obtained from all individual participants included in the study.

Consent for Publication

For this type of study consent for publication is not required.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplementary file1 (DOCX 157 kb)

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Tepe, G., Wang, J., Corpataux, JM. et al. BIOLUX P-III Passeo-18 Lux All-Comers Registry: 24-Month Results in Below-the-Knee Arteries. Cardiovasc Intervent Radiol 44, 10–18 (2021). https://doi.org/10.1007/s00270-020-02586-3

Download citation

Keywords

  • Peripheral artery disease
  • Below-the-knee
  • BTK
  • Infrapopliteal
  • Critical limb ischemia
  • Drug-coated balloon
  • Paclitaxel
  • Angioplasty