RANGER II SFA: Low-dose paclitaxel-coated balloon superior to PTA at 1 year
LAS VEGAS — A low-dose paclitaxel-coated balloon was superior to percutaneous transluminal angioplasty for treatment of femoropopliteal disease, according to results from a prespecified interim 1-year analysis from the RANGER II SFA trial presented at VIVA 19.
The PCB (Ranger, Boston Scientific), which has a paclitaxel dose density of 2 µg/mm2, had a higher rate of primary patency at 1 year compared with PTA (82% vs. 68.8%; P = .013), Ravish Sachar, MD, physician-in-chief for Heart and Vascular Services at the University of North Carolina – Rex Hospital, said at a press conference. He said the Kaplan-Meier estimates of 1-year primary patency were 89.2% in the PCB group and 72.9% in the PTA group (log-rank P = .0022).
The prespecified primary endpoint analysis included the first 306 patients from the cohort of 376 patients with peripheral artery disease in the femoropopliteal segment.
“There are three PCBs on the market right now, and there is a range of what we expect for 1-year patency associated with them,” Sachar told Cardiology Today. “This device came out at the top of that range, but accomplishes it with a smaller-profile balloon — with a platform of 0.018 in. compared with 0.035 in. — which makes deliverability a bit easier. This adds another tool to our toolbox with drug dosing in the lower end of the range of devices that are available currently.”
In other results, the rate of target lesion revascularization at 1 year was lower in the PCB group compared with the PTA group (6% vs. 19.9%; P = .0018).
“This device is at the lower end of the range of dose and the higher end of the range of outcomes,” Sachar said in an interview. “That combined with the deliverability is going to be very intriguing to a lot of physicians.”
All-cause mortality at 1 year did not differ between the groups (PCB group, 2.3%; PTA group, 2.5%; P > .99), Sachar said.
In a pharmacokinetics substudy of 12 patients with a mean lesion length of 154.2 mm, 11 of them had paclitaxel levels in venous plasma that were unmeasurable approximately 1 hour after deployment and removal of the PCB, Sachar said during a presentation.
“If you’re exposing someone to a lower dose of the drug but getting similar outcomes, that may be a driving factor for usage,” Sachar told Cardiology Today.
In addition, the rate of freedom from major adverse events at 1 year was numerically higher in the PCB group (PCB group, 93.5%; PTA group, 82.1%; P for noninferiority < .0001), he said.
Sustained clinical improvement 1 year was achieved in 86.1% of the PCB group and 76.6% of the PTA group (P = .055), he said.
Full 1-year data will be presented in the future, Sachar said.
Patients were Rutherford class 2, 3 or 4 and had stenosis in the superficial femoral or proximal popliteal arteries of at least 70%. They were randomly assigned on a 3:1 basis to receive the PCB or PTA. The PCB cohort had a mean age of 71 years, had 38% women and had 42.2% of its patients had diabetes. The PTA cohort had a mean age of 69 years, had 32% women and 43.9% of its patients had diabetes.
The PCB is not yet available for commercial use in the United States but is under review by the FDA. – by Erik Swain
Sachar R, et al. Late-Breaking Clinical Trials. Presented at: VIVA 19; Nov. 4-7, 2019; Las Vegas.
Disclosure: The study was funded by Boston Scientific. Sachar reports he serves on an advisory board and has conducted clinical trials for Boston Scientific.