July 12, 2022 — Biotronik announced the presentation of two studies on the performance of its drug-coated balloon catheter Passeo-18 Lux to this year LINC Congress in Leipzig, Germany. The BIO REACT study was designed to better understand when and where a stent is needed after a drug-coated balloon for the treatment of femoropopliteal artery injury in patients with peripheral arterial disease (PAD).1Dr. Michael LichtenbergChief Physician of the Arnsberg Vascular Center at Karolinen Hospital, Germany, revealed the 12-month results of this pilot study. Although the use of intraoperative ultrasound-Doppler in this small cohort did not improve the identification of flow-limiting dissections, the presentation data showed that the suitable combination therapy Biotronik REsponse – combining Passeo-18 Lux DCB to Pulsar-18 T3 thin strut stents when and where needed – is a safe and effective treatment for femoropopliteal lesions, while leaving less metal behind.
BIO REACT results at a glance:
12 months free of clinical target lesion revascularization (fCD-TLR): 94.8%
Primary patency at 12 months: 81.5%
Survival at 12 months: 97.2%
No major amputation of the target limb
“Identifying when to place a stent remains a complex issue, but 12-month results from the BIO REACT pilot study demonstrate that Passeo-18 Lux DCB is an effective stand-alone therapy with an fCD-TLR rate of 94.0%” , lead researcher Dr. Michael Lichtenberg commented on the results.
In another CLIC presentation, Ao.Univ.-Prof. Dr.med.univ Marianne Brodman, Medical University of Graz, Austria, reported the results of the Passeo-18 Lux DCB Long Lesion cohort, which combines the long lesion subset of the BIOLUX P-III all-comers registry and the BIOLUX P-III Spain study evaluating device performance in TASC C and D lesions > 15 cm. 2,3 In this pooled analysis, 159 patients with long and complex femoropopliteal lesions were treated with Passeo-18 Lux DCB. At 12 months, Passeo-18 Lux DCB showed good results in this real and challenging patient population (40.3% diabetes mellitus, 32.7% critical limb ischemia), with 84.4% fCD -TLR, 83.9% freedom from major adverse events, 98.6% freedom from major target limb amputation and 93.3% amputation-free survival. Consistent with results presented in the BIO REACT study, Passeo-18 Lux DCB was found to be an effective stand-alone treatment for complex lesions, with 60% of lesions not requiring a salvage stent despite the long length of the the lesion (average length of the lesion, 24.9 cm). “The treatment of long and complex TASC C and D femoropopliteal lesions with Passeo-18 Lux DCB as a stand-alone therapy has clearly been shown to be safe and effective,” Prof. Brodmann commented on the results.
“At Biotronik, we are proud to support the first study to ever assess the added value of intraoperative DUS over angiography alone in femoropopliteal disease, another example of our commitment to scientific research and better understanding. treatment of peripheral arterial disease,” noted Dr. Alexander Uhl, President Vascular Intervention at Biotronik. “The results of this study, in addition to the presented pooled analysis of the performance of Passeo-18 Lux DCB in long lesions, further add to the body of evidence supporting the safety and efficacy of this device.”
Randomized controlled trials and all-comers registries have studied the safety and effectiveness of Passeo-18 Lux DCB in treating over 1,900 patients with PAD in the infrainguinal arteries. Recently, compelling data on long-term performance and safety were presented at the Charing Cross Symposium in London, England.
For more information: www.biotronik.com
1. Pilot study on BIO REsponse adapted combination therapy. https://clinicaltrials.gov/ct2/show/NCT03547986.
2. BIOLUX P-III All-Comers Passeo-18 Lux Register. https://clinicaltrials.gov/ct2/show/NCT02276313.
3. BIOLUX P-III SPAIN All-Comers Registry. https://clinicaltrials.gov/ct2/show/NCT03052296.