Abstract
The JET-RANGER study (NCT03206762) was a multicenter (11 U.S. centers), randomized trial, core-lab adjudicated and designed to demonstrate the superiority of Jetstream + paclitaxel-coated balloon (JET + PCB) versus percutaneous transluminal angioplasty (PTA) + PCB in treating femoropopliteal arterial disease. The 1- and 2-year outcomes have been recently published. The 3-year outcome data are presented in this report. The JET-RANGER trial initially had 47 patients with 48 lesions. Thirty-one in the JET-PCB arm and 16 in the PTA + PCB arm (2:1 randomization). At 3-year follow-ups, there were 20 patients in the JET-PCB arm and 14 patients in the PTA + PCB arm. Kaplan-Meier survival analysis was performed to estimate the freedom from target lesion revascularization (TLR) at 3 years. Bailout stenting was not considered a TLR in this analysis. Statistical significance was determined by a p -value < 0.05. Freedom from TLR was statistically similar between the two groups at 3 years between JET + PCB and PTA + PCB (freedom from TLR was 88.0 vs. 67.8%, respectively, p = 0.1380). There was also no significant difference in the change of ankle-brachial index (ABI) between the PTA + PCB and JET + PCB from baseline at 6 months ( p = 0.7890), 1 year ( p = 0.4070), 2 years ( p = 0.7410), and 3 years ( p = 0.8010). There was also no statistical difference between the JET + PCB and PTA + PCB arms for RCC improvement by one or more categories from baseline to 3 years ( p = 0.8949). There were no minor or major amputations for either arm throughout the 3-year follow-up. Five JET + PCB patients died before the 3-year specified window and none in the PTA + PCB arm ( p = 0.137). Two of the deaths were due to cancer and three due to cardiac causes. None were deemed related to the device or procedure. JET + PCB had similar freedom from TLR and improvement in ABI and RCC at 3-year follow-up with no difference in amputation or mortality between the 2 arms. A trend toward less TLR was seen in the JET + PCB arm.