Biotronik’s Passeo-18 Lux Paclitaxel DCB Studied in Subgroup Analyses of BIOPACT RCT

July 13, 2023—Biotronik announced the 1-year subgroup results from the investigator-initiated BIOPACT randomized controlled trial (RCT) evaluating the safety and efficacy of the company’s Passeo-18 Lux drug-coated balloon (DCB) catheter compared to the In.Pact Admiral DCB (Medtronic).

The findings showed “excellent” results for both balloons through 12 months across a variety of subcohorts, noted the company.

The study’s principal investigator Koen Deloose, MD, presented the results at LINC 2023, the Leipzig Interventional Course held June 6-9 in Leipzig, Germany. Dr. Deloose is Head of the Department of Vascular Surgery, AZ Sint Blasius Hospital in Dendermonde, Belgium.

According to Biotronik, the prospective, multicenter, core-lab adjudicated noninferiority study was composed of 302 patients with Rutherford class 2-4 disease who were enrolled in Austria, Belgium, France, and Switzerland. The patients were randomized 1:1 to either the Passeo-18 Lux DCB or In.Pact Admiral DCB for the treatment of stenotic, nonstented restenotic or occlusive lesions in the femoropopliteal artery.

The primary safety endpoint was a composite of freedom from device- and procedure-related death through 30 days postindex procedure and freedom from major target limb amputation and clinically driven target vessel revascularization through 12 months post-index procedure.

As summarized in Biotronik’s press release, there were no statistically significant differences in the Passeo-18 Lux DCB versus the In.Pact Admiral DCB for the full data set and across subgroups:

• Diabetes: 94.7% vs 95.2% (diabetic patients); 97.1% vs 95.6% (nondiabetic patients)
• Lesion length: 95.9% vs 90% (target lesions ≥ 100 mm); 96.7% vs 97.9% (target lesions < 100 mm)
• Calcium: 98.1% vs 96.8% (severely calcified lesions); 92.9% vs 89.7% (none/moderately calcified lesions)
• Bailout stenting: 100% vs 100% (with bailout stenting); 96.1% vs 95% (without bailout stenting)
• Occlusions: 100% vs 100% (in occlusions); 95.8% vs 94.7% (in stenoses)

“Interestingly, we found that across all variations and cohorts, there was no statistically significant difference in safety, primary patency, or clinically driven target lesion revascularization,” commented Dr. Deloose in Biotronik’s press release. “There is a scarcity of randomized head-to-head data, especially in the DCB space, so the more data we have available, the more answers we have.”

The company noted that 1-year results from the full cohort of the BIOPACT RCT showed comparable results between treatment arms, with a freedom from clinically driven target lesion revascularization rate of 97.2% for Passeo-18 Lux DCB and 97% for In.Pact Admiral DCB (P = .0002). Dr. Deloose presented the full cohort results at the Paris Vascular Insights 2022 congress.

The BIOPACT study will continue collecting follow-up data at 24, 36, 48, and 60 months, which will be shared upon completion of each follow-up period. The 24-month full-cohort results will be announced later this year, advised the company.

According to Biotronik, the Passeo-18 Lux DCB has a paclitaxel dose of 3.0 µg/mm² and uses a butyryl-tri-hexyl citrate excipient. The In.Pact Admiral DCB has a dose of 3.5 µg/mm² and a urea excipient. The lower-profile Passeo-18 Lux DCB is on an 0.018-inch platform and is 4-F compatible for diameters of 2 to 4 mm and 5-F compatible for diameters of 5 to 7 mm. The In.Pact Admiral DCB is 5-F compatible only for its 4-mm diameter, and is 6- or 7-F compatible for its diameters of 5 to 7 mm.

The company announced the launch of Passeo-18 Lux DCB in Europe in January 2014 after receiving CE Mark approval. In the United States, the Passeo-18 Lux DCB is not available for sale or use, advised Biotronik.