Bard’s Lutonix drug-coated balloon tested in hemodialysis arteriovenous fistulae
Paclitaxel-coated balloons have the potential to reduce restenosis in arterial applications and in small trials in hemodialysis access, according to Dr. Scott Trerotola, who presented data from a trial of C. R. Bard‘s (NYSE:BCR) Lutonix DCB at VIVA this year.
The multicenter trial evaluated the Lutonix drug-device combo in hemodialysis arteriovenous fistulae. The study enrolled 285 patients with dysfunctional AVF and all of them received percutaneous transluminal angioplasty of the lesion responsible for access dysfunction.
After PTA, researchers treated the lesions with either a paclitaxel-coated balloon or an uncoated balloon.
The study’s endpoints included postintervention target lesion primary patency at 6, 9, 12, 18 and 24 months, as well as safety.
The primary safety endpoint was met and did not differ between groups, the team reported. The six-month efficacy endpoint was not met – patients who received the DCB had a TLPP rate of 71% compared to 63% for the control group.
However, the team noted that at the end of the six-month window, the TLPP rate was superior for the DCB group compared to the control group – 64% and 53%, respectively.
At six months, interventions to maintain target lesion patency were fewer for the DCB group than the control group. After 18 months, the team reported a 37% improvement in TLPP for the DCB group compared to the control group.