Findings Presented From Biotronik's Lower Limb Clinical Trials

April 26, 2018—Biotronik announced the latest results of three lower limb clinical trials—BIOLUX P-III, BIOFLEX PEACE, and BIOLUX 4EVER—which were presented at the Charing Cross International Symposium held April 24–27 in London, United Kingdom.

Professor Marianne Brodmann, MD, presented 12-month results of the full cohort of BIOLUX P-III, which was composed of 882 patients treated with the Passeo-18 Lux drug-coated balloon (DCB). The initial all-comers cohort of 700 patients was expanded to include complex subgroups such as those with TASC C/D and below-the-knee (BTK) lesions. The all-comers cohort data were presented at LINC 2018: the Leipzig Interventional Course, held January 30 to February 2 in Leipzig, Germany.

The company stated that despite a severely diseased population, with 17.1% BTK lesions, 42.6% critical limb ischemia (CLI; including Rutherford class 6), and 47.6% of patients with diabetes, the freedom from clinically driven target lesion revascularization (TLR) rate was 93.5% at 12 months, with 84.3% primary patency. “Passeo-18 Lux consistently shows a benefit in a high-risk population,” concluded Prof. Brodmann in the company's announcement.

Gunnar Tepe, MD, presented 12-month results of the BIOLUX P-III BTK subgroup. This subgroup included 150 patients including those with CLI (76.7%), of which 26.7% were Rutherford class 6. The company stated that the 12-month results were encouraging for both safety and efficacy, with a low major target limb amputation rate of 7.8% (Kaplan-Meier estimate) and a freedom from clinically driven TLR rate of 92.4%.

Michael Lichtenberg, MD, presented the complete 24-month study results from the BIOFLEX PEACE all-comers registry, which investigated the Pulsar-18 self-expanding bare-metal stent (BMS) in femoropopliteal lesions in 160 patients. At 24 months, the Pulsar-18 stent achieved a favorable Kaplan-Meier primary patency rate of 78.4% and freedom from clinically driven TLR rate of 89.3%. In addition, Dr. Lichtenberg presented the DCB plus stent subgroup analysis showing a favorable outcome for very complex lesions.

Finally, Koen Deloose, MD, presented findings on the long-term benefits of combination therapy in the BIOLUX 4EVER study of full-lesion coverage with Passeo-18 Lux followed by the Pulsar-18 BMS in 120 patients. Dr. Deloose advised that the 24-month outcomes for the full cohort demonstrated primary patency of 83.5% and freedom from TLR of 86.1%.