Biotronik has announced the presentation of two-year results from the investigator-initiated BIOPACT randomised controlled trial (RCT) by principal investigator Koen Deloose (AZ Sint-Blasius Hospital, Dendermonde, Belgium) at the Paris Vascular Insights (PVI) 2023 congress (8–10 November, Paris, France). The randomised controlled non-inferiority trial evaluated the safety and efficacy of the Passeo-18 Lux drug-coated balloon (DCB) catheter compared to the IN.PACT Admiral DCB (Medtronic), and showed excellent results for both balloons through 24 months.
The prospective, multicentre, core-lab adjudicated non-inferiority trial enrolled 302 patients in Austria, Belgium, France and Switzerland with Rutherford Class 2–4 disease. Patients were randomised 1:1 to either the Passeo-18 Lux DCB or IN.PACT Admiral DCB for the treatment of stenotic, non-stented restenotic or occlusive lesions in the femoropopliteal artery. Baseline patient and lesion characteristics were comparable across both arms.
As presented at PVI, the rate of clinically driven target lesion revascularisation (CD-TLR) for the Passeo-18 Lux DCB was noninferior to the IN.PACT Admiral DCB at 12 months, which was maintained at 24 months (93.3%, Passeo-18 Lux DCB vs. 94.6%, IN.PACT Admiral DCB at 24 months; p=0.0048).
Survival was also equivalent at 24 months, with a 95% rate of overall survival for both devices, and there were no major target limb amputations in either arm.
“The two-year results of the BIOPACT RCT have continued to demonstrate the noninferiority of the safety and efficacy of the Passeo-18 Lux DCB to the IN.PACT Admiral DCB, and they show persistent excellence of both devices,” said Deloose. “This study is critically needed to fill the gap of head-to-head data for peripheral DCBs to keep the most effective treatments accessible to our patients.”
The Passeo-18 Lux DCB has a paclitaxel dose of 3µg/mm2 and uses a Butyryl-tri-hexyl citrate excipient (IN.PACT Admiral DCB: 3.5µg/mm2 and urea excipient). The lower-profile Passeo-18 Lux DCB is on an 0.018″ platform and is 4-French compatible for diameters of 2–4mm and 5-French compatible for diameters of 5–7mm. In comparison, the IN.PACT Admiral DCB is 5-French compatible only for its 4mm diameter, and is 6-French or 7-French compatible for its diameters of 5–7mm.
“We are delighted to see confirmation of the continued performance and safety of our Passeo-18 Lux DCB in this important RCT, which will support our access in key new markets,” said Stuart Perks, vice president marketing vascular intervention at Biotronik.
A press release details that the BIOPACT RCT study will continue collecting follow-up data at 36, 48 and 60 months, which will be shared upon completion of each follow-up period.
