BD Reports Results from AV Fistula Cohort of Lutonix AV Global Registry

May 21, 2025—BD (Becton, Dickinson and Company) announced post hoc analysis results from the arteriovenous (AV) fistula cohort of the Lutonix Global AV Registry. The registry assessed the safety and effectiveness of the company’s Lutonix 035 drug-coated balloon (DCB) in a real-world setting at 25 sites across Europe and Asia (N = 320).

According to the company, the reported post hoc analysis findings from the AV fistula cohort (n = 124) included an estimated 6-month target lesion primary patency (TLPP) rate of 87.7% with predilation and inflation times of > 2 minutes for the Lutonix 035 DCB in the treatment of dysfunctional AV fistulas. TLPP was defined as the interval following the index procedure until clinically driven reintervention of the target lesion or access thrombosis.

The data were presented at CiDA 2024, the Controversies in Dialysis Access meeting held October 3-5 in Washington, DC, and at EVA 2024, the Endo Vascular Access meeting held June 14-15 in Patras, Greece.

As summarized in the BD press release, TLPP was 85.1% at 6 months for patients treated with the Lutonix 035 DCB (Kaplan-Meier [K-M] estimate; 92 evaluable patients).

The primary safety endpoint—defined as freedom from localized or systemic serious adverse events involving the AV access circuit through 30 days—was 94.9% for those patients treated with the Lutonix 035 DCB who did not have any such event.

BD further reported that subgroup analyses observed higher estimated 6-month TLPP rates with greater vessel preparation pressure or longer Lutonix 035 DCB inflation times, as follows:

• TLPP of 86.7% for patients treated with a vessel preparation pressure of ≥ 25 atm versus 84.8% when < 25 atm was used (based on K-M estimates; 15 and 109 evaluable patients, respectively).
• TLPP of 80.0%, 83.3%, and 87.5% for patients treated with the Lutonix 035 DCB with inflation times of 0 to 60 seconds, 61 to 120 seconds, and 121 to 180 seconds, respectively (based on K-M estimates; 15, 46, and 62 evaluable patients, respectively).
• TLPP of 87.7% for patients who had predilation and Lutonix 035 DCB inflation times > 120 seconds (based on K-M estimates; 15 and 62 evaluable patients, respectively).

The company noted that the cohort (49.0% White, 46.9% Asian) represented a challenging patient population characterized by multiple comorbid conditions such as diabetes (34.7%) and hypertension (70.2%), making their medical care complex. Properly managing vessel preparation pressure and DCB inflation times are potential factors in maintaining patency rates warranting further study, concluded the study.