In October 2014, Biotronik announced the first implantation of the Passeo-18 Lux drug-eluting balloon in the BIOLUX P-III all-comers registry. The purpose of the prospective, multicenter study is to collect and assess safety and efficacy data on the balloon for the treatment of obstructive disease of the infrainguinal arteries.
The Passeo-18 Lux design is based on that of the Passeo-18 uncoated balloon catheter, combined with a balloon coating containing a matrix of antiproliferative paclitaxel and butyryl trihexyl citrate, a biocompatible excipient to enable optimal drug transfer to the target lesion tissue. The primary endpoints of the study are freedom from clinically driven target lesion revascularization (TLR) at 12 months as well as freedom from major adverse events. This is measured as a composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and clinically driven TLR within 6 months after the procedure. Vascular Disease Management spoke with clinical investigator Gunnar Tepe, MD, head of the Institute of Diagnostic and Interventional Radiology at RoMed Clinic Rosenheim in Germany, about the study.
Q: Please describe your involvement in the study and your clinical experience with this balloon.
A: I am the coordinating clinical investigator of the BIOLUX P-III study. I have been involved in previous studies of Biotronik’s Passeo-18 Lux drug-eluting balloon. Our clinic was the highest enrolling site in the BIOLUX P-I study, which was a first-in-man, prospective, multicenter, 1:1 randomized controlled trial for the treatment of femoropopliteal arteries. We treated 22 patients during the BIOLUX P-I trial at our hospital.
A: The BIOLUX P-III study began enrollment at the end of October 2014. The goal is to enroll at least 700 patients in 55 sites from 19 countries in Europe, Australia, and Asia Pacific. Our clinic has enrolled 3 patients to date and hopes to enroll a total of 30 to 40 patients. Many members of the medical community are enthusiastic about drug-eluting balloons and we hope enrollment will proceed quickly.
Q: Could you describe the case of the first implantation?
A: Of the 3 patients implanted to date, 2 patients had below-the-knee (BTK) artery disease, and one had in-stent restenosis. All BTK lesions were proximal. I experienced no technical challenges: as hoped, Passeo-18 Lux behaved like a conventional balloon. Without intervention, the in-stent restenosis patient might not have been able to walk as far and the BTK artery disease patients might have faced amputation.
Q: What information are you most interested in collecting from this registry?
A: The BIOLUX P-III registry is particularly exciting for several reasons:
- Unlike other existing registries, it extends to below-the-knee arteries.
- It includes a diverse patient population with lesion characteristics not typically enrolled in clinical studies, such as long lesions and occlusions.
- As an “all-comers” registry, it will provide real-world evidence on the role of Passeo-18 Lux in treating peripheral artery disease in all of its complexity.
Q: What questions could this study answer for vascular specialists?
A: The study assesses the performance of Passeo-18 Lux in routine practice. It will help us understand the benefits of drug-eluting balloons in specific patient populations, locations, and lesion types.
Q: What other important point about the study and device should vascular specialists know?
A: Passeo-18 Lux is one of the few drug-eluting balloons on the market with an insertion aid so that physicians do not have to touch the balloon, improving ease of use. The balloon’s low profile sheath size (4 Fr/5 Fr compatibility) allows physicians to make a small puncture hole in the artery. Most importantly, the BIOLUX P-III study has a much larger patient population that previously studied. To truly know the drug-eluting balloon’s efficacy in the real world, we need robust data for as many patients as possible.