BIOLUX AV Randomized Controlled Trial Demonstrates Safety and Efficacy of Passeo-18 Lux DCB in Treatment of Dysfunctional Hemodialysis Access

Recent data from the investigator-initiated, randomized controlled trial (RCT), BIOLUX AV, showed that the treatment of patients with dysfunctional hemodialysis access (HA), with BIOTRONIK's Passeo^®-18 Lux^TM drug-coated balloon (DCB)*, is safe and effectively prevents HA failure**.

Patients (N = 120) with dysfunctional HA underwent initial high-pressure balloon angioplasty and were randomly assigned for a second angioplasty using either the Passeo-18 Lux DCB or a plain percutaneous transluminal angioplasty (PTA) balloon. Patients were initially followed-up for one year, and quantitative angiography was performed six months after angioplasty.

The one-year data, presented by Prof. Eric Therasse at LINC 2021,¹ the Leipzig Interventional Course, and published in the Journal of Vascular and Interventional Radiology,² showed that, in comparison with uncoated balloon PTA, DCB angioplasty was associated with a significantly lower HA failure rate and need for reintervention.

Serious adverse events related to HA were less frequent after DCB treatment than after plain PTA. The study principal investigator also stressed that this study, as with previous ones^3,4 using DCBs in HA lesions, did not demonstrate a significant increase in mortality in the DCB group.

Key results from the BIOLUX AV trial publication:

• At 12 months, the Kaplan-Meier patency estimate in the DCB arm was 62.6% vs 35.2% for the plain PTA group (P = 0.001).
• In comparison with plain PTA, DCB angioplasty was associated with significantly greater time to HA circuit failure (mean estimate [95% confidence interval], 267 vs 209 days; P = 0.009) and HA target lesion failure (mean estimate [95% confidence interval], 294 vs 218 days; P = 0.001).
• 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 three years (1,103 days; P = 0.31). This is the only AV 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. Eric Therasse, BIOLUX AV principal investigator and Professor at the Department of Radiology, Radio-Oncology and Nuclear Medicine at the University of Montreal, Canada. 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.

"Our results show the clinical benefit of DCBs to prevent hemodialysis access failure. Both hemodialysis access circuit and hemodialysis access target lesion failures were significantly reduced in the DCB group," summarized Prof. Eric Therasse.

"The BIOLUX AV study contributes to a growing body of evidence exploring Passeo-18 Lux, along with other DCBs improving the treatment of dysfunctional HA," commented Dr. Alexander Uhl, President Vascular Intervention at BIOTRONIK. 

References:

1. Therasse, E. Safety and efficacy of drug eluting balloon angioplasty of dialysis fistula: 12-month outcomes from a randomized clinical trial with Passeo-18 Lux. Presented at: LINC 2021. January 29, 2021.

2. Therasse, E, Caty V, Gilbert P, et al. Safety and efficacy of paclitaxel-eluting balloon angioplasty for dysfunctional hemodialysis access: a randomized trial comparing with angioplasty alone. J Vasc Interv Radiol. 2020; https://doi.org/10.1016/j.jvir.2020.10.030.

3. Lookstein RA, Haruguchi H, Ouriel K, et al. Drug-coated balloons for dysfunctional dialysis arteriovenous fistulas. N Engl J Med. 2020; 383:733–742.

4. Morena-Sánchez T, Moreno-Ramírez M, Machancoses FH, et al. Efficacy of paclitaxel balloon for hemodialysis stenosis fistulae after one year compared to high-pressure balloons: a controlled, multicenter, randomize trial. Cardiovasc and Interv Radiol. 2020;43:382-390.