Six-month results of the Lutonix arteriovenous (AV) Global registry were recently published in the Journal of Vascular and Interventional Radiology (JVIR). The data confirm that the Lutonix 035 drug-coated balloon (DCB) catheter (BD) is safe and effective in real-world patients with dysfunctional arteriovenous fistulas (AVFs) or AV grafts (AVGs).
The multicentre, prospective Lutonix AV Global registry enrolled 320 patients from 12 countries in 25 sites across Europe and Asia. A total of 392 lesions were treated with the Lutonix DCB. Both de novo and restenotic lesions were included, and lesions were located in every part of the circuit, from the cannulation zone to central venous outflow. In-stent restenostic lesions were also treated.
Writing in JVIR, authors Dimitrios Karnabatidis (Patras University Hospital, Patras, Greece) and colleagues detail that the primary safety endpoint—freedom from serious adverse events involving the access circuit through 30 days—was achieved in 95.5% of patients, while target lesion primary patency was 73.9% at six months, per Kaplan-Meier analysis
In addition, they report that access circuit primary patency was 71% at six months, and that target lesion primary patency for stenosis of AVFs was 78.1%.
Finally, the authors relay that subgroup analysis showed significantly improved target lesion primary patency when DCB was dilated for ≥120 seconds (p=0.007), and that target lesion primary patency was significantly better when predilation occurred compared with cases where only DCB angioplasty was performed (77% vs. 48.6%; p=0.0005).