Biotronik announced the presentation of two studies on the performance of its drug-coated balloon (DCB) catheter Passeo-18 Lux at the Leipzig Interventional Course (LINC) 2022 (6–9 June, Leipzig, Germany).
The BIO REACT study was designed to better understand when and where a stent is needed following DCB for the treatment of femoropopliteal artery lesions in patients with peripheral arterial disease (PAD). Principal investigator Michael Lichtenberg (Arnsberg Vascular Center at Karolinen Hospital, Arnsberg, Germany) revealed the 12-month outcomes of this pilot study at LINC 2022.
While the use of intraoperative duplex ultrasound in this small cohort did not improve the identification of flow-limiting dissections, according to a company press release, the presented data showed that Biotronik Response Adapted Combination Therapy—combining Passeo-18 Lux DCB with Pulsar-18 T3 thin-strut stents when and where needed—is a safe and effective treatment of femoropopliteal lesions, while leaving less metal behind.
In the press release, Biotronik reports the following outcomes from BIO REACT:
- Twelve-month freedom from clinically driven target lesion revascularisation (fCD-TLR): 94.8%
- Twelve-month primary patency: 81.5%
- Twelve-month survival: 97.2%
- No major target limb amputation
“Identifying when to place a stent remains a complex issue, but the 12-month outcomes of the BIO REACT pilot study demonstrate that the Passeo-18 Lux DCB is an effective standalone therapy with a fCD-TLR rate of 94.0%,” Lichtenberg commented.
In another LINC presentation, Marianne Brodmann (Medical University Graz, Graz, Austria) reported the results of the Passeo-18 Lux DCB long lesion cohort, which combines the BIOLUX P-III all-comers registry’s long lesion subgroup and the BIOLUX P-III Spain study evaluating device performance in TASC C and D lesions >15cm.
In this pooled analysis, 159 patients with long and complex femoropopliteal lesions were treated with Passeo-18 Lux DCB. At 12 months, Biotronik reveals, the Passeo-18 Lux DCB showed good results in this real-world, challenging patient population (40.3% diabetes mellitus, 32.7% chronic limb-threatening ischaemia), 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.
The press release adds that, consistent with the results presented from the BIO REACT study, the Passeo-18 Lux DCB was shown to be an effective standalone treatment for complex lesions, with 60% of lesions not needing bailout stenting despite the long lesion length (mean lesion length, 24.9cm). “The treatment of long, complex TASC C and D femoropopliteal lesions with Passeo-18 Lux DCB as a standalone therapy is clearly shown to be safe and effective,” remarked Brodmann.
Biotronik advises that randomised controlled trials and all-comers registries have investigated safety and efficacy of Passeo-18 Lux DCB in the treatment of over 1,900 patients with PAD in the infrainguinal arteries.