BIBLIOS study first results on BTK lesions presented at linc

iVascular presented for the first time Luminor in BTK outcomes obtained in the BIBLIOS trial at LINC 2022 (Leipzig Interventional Course) and its first preliminary results on below-the-knee lesions.

BIBLIOS study is a prospective, single-arm, multicentre study conducted in 8 sites across Belgium, Italy and Spain. A total of 150 subjects with critical limb ischemia (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 period of 12 months.

Dr. Koen Deloose (AZSint Blasius, Belgium), the study’s principal investigator remarks: “Until now, DCBs in BTK haven’t achieved the same outcomes as in femoropopliteal, because the necessity is different. It’s important to accurately define the type of patients included and have a wound care protocol well established. This is the main point of BIBLIOS trial.”

The efficacy primary endpoint of BIBLIOS is freedom from major adverse limb events (MALE) at 6 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 clinically driven target lesion revascularization (CD-TLR), amputation-free survival, limb salvage, procedural success and wound healing status and time.

The 12-month preliminary data of 100 subjects presented at LINC 2022 by Dr. Deloose, confirmed the excellent safety and efficacy of Luminor DCB in BTK: Freedom of peri-operative death and freedom of MALE at 30 days were 98% and 99%, respectively. Also, those values were maintained at 6 months. At 1-year freedom from CD-TLR achieved was 88.0%

In his presentation, Dr.Deloose highlighted: “These results showed that Luminor clinical performance and safety profiles are very good for the treatment of infrapopliteal lesions in patients with critical limb ischemia. Final results of the primary endpoint including all enrolled patients (n=150) will be presented upon completion of 12-month follow-up in 2023”.

01/11/2022