iVascular reflect on the Luminor drug-coated balloon (DCB) in below-the-knee (BTK) outcomes obtained in the BIBLIOS trial one-year follow-up presented at the Paris Vascular Insights (PVI) 2023 (8–10 November, Paris, France).
BIBLIOS is a prospective, single-arm, multicentre study conducted in eight sites across Belgium, Italy and Spain.
A total of 150 subjects with critical limb-threatening ischemia (CLTI) Rutherford class 5 undergoing a significant degree of stenosis <70% or chronic total occlusion in P3 to the ankle-joint level lesions were enrolled with a follow-up of 12 months.
The efficacy primary endpoint of BIBLIOS is freedom from major adverse limb events (fMALE) at six months, defined as the absence of above-ankle target limb amputation or major reintervention to the target lesion(s). The primary safety endpoint is freedom from MALE at 30 days. Key secondary endpoints include target vessel functional flow assessment, freedom from clinical driven target lesion revascularisation (CD-TLR), amputation free survival, limb salvage, procedural success and wound healing status and time.
Koen Deloose (AZ Sint Blasius, Dendermonde, Belgium), the study’s principal investigator, highlighted that: “BIBLIOS’ objective is to confirm the safety and efficacy of Luminor in BTK in a well-defined study. Patient selection and wound care protocol are mandatory with this type of patients and illness. In BIBLIOS we tried to overcome some of the flaws in BTK trials/treatment: strategy, treatment, protocols and follow-up.”
12-month data of 150 subjects confirmed the excellent safety and efficacy of Luminor in BTK: at 1-year freedom from CD-TLR achieved was 86.6%. Freedom from MALE (95.6%) was maintained during the 12-month follow-up.
During his presentation at PVI, Deloose concluded: “These results showed that Luminor is a great option for the treatment of infrapopliteal lesions in patients with CLTI. It’s effective, it’s safe, and it’s available in all guidewire compatibilities and with small diameters”.
