BIOLUX AV trial demonstrates safety and efficacy of Passeo-18 Lux DCB in treatment of dysfunctional haemodialysis access

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Passeo-18 Lux DCB

Recent data from the investigator-initiated, randomised controlled trial (RCT), BIOLUX AV, showed that the treatment of patients with dysfunctional haemodialysis access with BIOTRONIK‘s Passeo-18 Lux drug-coated balloon (DCB), is safe and effectively prevents access failure.

Patients (n=120) with dysfunctional haemodialysis access 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 Eric Therasse (Centre Hospitalier de l’Université de Montréal, Montréal, Canada) at LINC 2021 (The Leipzig Interventional Course, 25–29 January, online) and published in the Journal of Vascular and Interventional Radiology, showed that, in comparison with uncoated balloon PTA, DCB angioplasty was associated with a significantly lower haemodialysis access 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 using DCBs in haemodialysis access 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 haemodialysis access circuit failure (mean estimate [95% confidence interval], 267 vs. 209 days; p=0.009) and haemodialysis access target lesion failure (mean estimate [95% confidence interval], 294 vs. 218 days; p=0.001).
  • Serious adverse events related to haemodialysis access 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).

“DCBs with paclitaxel have demonstrated variable results to prevent haemodialysis access restenosis in a few RCTs, and, until recently, their effectiveness was unclear,” explained Therasse, BIOLUX AV principal investigator. The study investigators hypothesised 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 haemodialysis access restenosis rate at the treated site.

“Our results show the clinical benefit of DCBs to prevent haemodialysis access failure. Both haemodialysis access circuit and haemodialysis access target lesion failures were significantly reduced in the DCB group,” summarised Therasse.


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