BIOLUX AV Trial Evaluates Biotronik’s Passeo-18 Lux DCB in Treatment of Dysfunctional Hemodialysis Access

February 1, 2021—Biotronik announced that recent data from the investigator-initiated, BIOLUX AV randomized controlled trial (RCT) showed that the treatment of patients with dysfunctional hemodialysis access (HA) with the company’s Passeo-18 Lux drug-coated balloon (DCB) is safe and effective in the prevention of HA failure.

The 1-year data showed that in comparison with percutaneous transluminal angioplasty (PTA) using an uncoated balloon, DCB angioplasty was associated with a significantly lower HA failure rate and need for reintervention.

The findings were presented by Professor Eric Therasse, MD, at LINC 2021, the Leipzig Interventional Course held as a virtual event January 25-29. Additionally, Prof. Therasse et al published the study online ahead of print in Journal of Vascular and Interventional Radiology.

According to the company, the study enrolled 120 patients with dysfunctional HA who underwent initial high-pressure balloon angioplasty. The patients were randomly assigned for a second angioplasty using either the Passeo-18 Lux DCB or a plain PTA balloon. Patients were initially followed up for 1 year, and quantitative angiography was performed 6 months after angioplasty.

The investigators found that serious adverse events related to HA were less frequent after DCB treatment than after plain PTA.

Prof. Therasse, the study’s Principal Investigator, also stressed as with previous studies using DCBs in HA lesions, this study did not demonstrate a significant increase in mortality in the DCB group.

As summarized by Biotronik, key results from the BIOLUX AV trial included the following:

• At 12 months, the Kaplan-Meier patency estimate in the DCB arm was 62.6% versus 35.2% for the plain PTA group (P = .001).
• In comparison with plain PTA, DCB angioplasty was associated with significantly greater time to HA circuit failure (mean estimate [95% CI], 267 vs 209 days; P = .009) and HA target lesion failure (mean estimate [95% CI], 294 vs 218 days; P = .001).
• Serious adverse events related to HA were less frequent after DCB than after plain PTA.
• Survival after DCB and plain PTA were not significantly different at 12-month follow-up and through a median follow-up of approximately 3 years (1,103 days; P = .31). This is the only arteriovenous RCT reporting mortality data up to 3-year follow-up.

“DCBs with paclitaxel have demonstrated variable results to prevent HA restenosis in a few RCTs, and, until recently, their effectiveness was unclear,” explained Prof. Therasse in Biotronik’s press release. “The study investigators hypothesized that differences in paclitaxel dosages and excipients of DCBs may be responsible for these variable results and that, in comparison to plain PTA, the paclitaxel-coated balloon technology used in the Passeo-18 Lux would significantly decrease the HA restenosis rate at the treated site.”

Prof. Therasse concluded, “Our results show the clinical benefit of DCBs to prevent HA failure. Both HA circuit and HA target lesion failures were significantly reduced in the DCB group.” Prof. Therasse is from the Department of Radiology, Radio-Oncology and Nuclear Medicine at the University of Montreal in Montreal, Canada.