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

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

A Correction to this article was published on 11 May 2021

This article has been updated

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

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Availability of Data and Material

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

Change history

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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

Authors and Affiliations

  1. Institut für Diagnostische und Interventionelle Radiologie, RoMed Klinikum Rosenheim, Pettenkoferstr. 10, 83022, Rosenheim, Germany

    Gunnar Tepe

  2. Department of Vascular Surgery, Singapore General Hospital, Singapore, Singapore

    John Wang

  3. Department of Thoracic and Vascular Surgery, Lausanne University Hospital, Lausanne, Switzerland

    Jean-Marc Corpataux

  4. Department of Diagnostic Radiology, Tan Tock Seng Hospital, Singapore, Singapore

    Uei Pua

  5. Radiology Institute, Kantonsspital Winterthur, Winterthur, Switzerland

    Christoph A. Binkert

  6. Department of Angiology, Institute of Cardiovascular Diseases, Kosice, Slovakia

    Matej Moscovic

  7. Klinik für Gefäßchirurgie, Helios Klinikum München West, Munich, Germany

    Reza Ghotbi

  8. Department of Vascular Surgery, Regional Hospital Heilig Hart, Tienen, Belgium

    Koen Keirse

  9. Interventional Radiology, University Hospital Geelong, Geelong, Australia

    Donald Robertson

  10. Division of Angiology, Department of Internal Medicine, Medical University Graz, Graz, Austria

    Marianne Brodmann

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  1. Gunnar Tepe
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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.

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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.

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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.

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

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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

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