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.
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).
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.
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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.
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We thank Beatrix Doerr for her assistance in preparing this manuscript, reimbursed by BIOTRONIK AG.
This study was funded by BIOTRONIK AG, Buelach, Switzerland. The sponsor was involved in the design of the study, data collection and data analysis.
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.
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 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
- Peripheral artery disease
- Critical limb ischemia
- Drug-coated balloon