Scott Trerotola presented the first release of eight-month data from the Lutonix AV IDE trial at the Leipzig Interventional Course (LINC; 24–27 January, Leipzig, Germany) and showed that drug-coated balloons (Lutonix 035 AV from Bard) are linked with a significantly higher target lesion patency and far fewer reinterventions to maintain this opening in a wide variety of failing arteriovenous fistulas than standard angioplasty.
Commenting on the significance of the data, Trerotola (University of Pennsylvania Medical Center, Philadelphia, USA) said: “This is the first trial in the 51 years since fistulas have been created to look at an intervention for lesions within native fistulas in a prospective, randomised, multicentre fashion. A lot of things [different technologies] have been tried; this is the first one that has worked.” See video interview.
The Lutonix AV study is a prospective, global, multicentre, randomised, controlled study designed to evaluate the safety and effectiveness of the Lutonix 035 AV drug-coated balloon catheter compared to a standard percutaneous transluminal angioplasty catheter in treating patients presenting with clinical and haemodynamic abnormalities in native arteriovenous fistulae located in the upper extremity. The investigators randomised 285 patients at 23 clinical sites and Trerotola noted that this was the trial incorporated a wide variety of lesions and fistula types.
The primary safety endpoint was freedom from any serious adverse events involving the arteriovenous access circuit through 30 days. The primary effectiveness endpoint was target lesion primary patency at six months.
The results at 240 day demonstrated that the procedure, when the drug-coated balloon was used, was as safe as the control procedure, percutaneous transluminal angioplasty. “The target lesion primary patency, showing the effect of the drug, was 61.6% for the drug-coated balloon as compared to 49.4% for percutaneous transluminal angioplasty (p=0.02). The number of interventions required to maintain target lesion patency at 240 days was 66 in the drug-coated balloon group and 94 in the plain angioplasty group (p=0.024) meaning that there were 29.8% fewer interventions required to maintain target lesion patency in the drug-coated balloon arm than the control arm,” Trerotola told delegates.
Interestingly, the 180-day target lesion primary patency was not significantly different between the two treatment groups and a convergence of curves were seen at that point. As this was the primary endpoint, Trerotola noted that it was not met, but clarified that this was a “statistical blip” as the curves continue to clearly diverge by the 240-day mark.
“The most important finding is that starting at about 60 days, there is a divergence in the curves with a sustained benefit that reaches statistical significance at 240 days for the drug-coated balloon compared to the control arm. In addition to that, the number of interventions to maintain target lesion patency was significantly fewer than in the control arm,” Trerotola added in an interview with Interventional News.
There were 141 patients who were treated with the drug-coated balloon and 144 who were treated with plain balloon angioplasty. The patients were evenly matched in both groups with baseline demographics between the two groups being similar. There were over 95% in both groups being hypertensive and around 60–65% being diabetic. Fistulae that were treated reflected an American population and were in the upper arm, antecubital fossa and forearm. The treated vessel locations included the cephalic vein, basilic vein, median cubital vein and subclavian vein.
With regard to lesion characteristics, there were 30.5% de novo lesions and 2.8% tandem lesion in the group treated with drug-coated balloon and 27.1 de novo lesions and 7% tandem lesions in the group treated with plain balloon angioplasty. The target lesion length was 28.4±15.09mm in the drug-coated balloon group and 29.5±18.69 in the plain balloon angioplasty group.
The Lutonix AV study is a two-year study and data will be accrued for this period. Trerotola is scheduled to present the nine-month results at the Society of Interventional Radiology’s annual scientific meeting in March.