Shammas Nicolas W, Shammas Gail, Jones-Miller Sue
Midwest Cardiovascular Research Foundation, Cardiovascular Research, Davenport, Iowa.
Int J Angiol. 2024 Oct 3;34(1):56-59. doi: 10.1055/s-0044-1791546. eCollection 2025 Mar.
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 -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, = 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 ( = 0.7890), 1 year ( = 0.4070), 2 years ( = 0.7410), and 3 years ( = 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 ( = 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 ( = 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.
JET-RANGER研究（NCT03206762）是一项多中心（美国11个中心）随机试验，由核心实验室判定，旨在证明Jetstream紫杉醇涂层球囊（JET+PCB）对比经皮腔内血管成形术（PTA）+PCB治疗股腘动脉疾病的优越性。1年和2年的研究结果最近已发表。本报告展示了3年的研究结果。JET-RANGER试验最初纳入了47例患者的48处病变。JET-PCB组31例，PTA+PCB组16例（随机分组比例为2:1）。在3年随访时，JET-PCB组有20例患者，PTA+PCB组有14例患者。采用Kaplan-Meier生存分析来估计3年时靶病变血运重建（TLR）的无事件生存率。在本分析中，补救性支架置入不被视为TLR。通过P值<0.05确定统计学显著性。JET+PCB组和PTA+PCB组在3年时TLR的无事件生存率在统计学上相似（TLR的无事件生存率分别为88.0%和67.8%，P=0.1380）。PTA+PCB组和JET+PCB组在6个月（P=0.7890）、1年（P=0.4070）、2年（P=0.7410）和3年（P=0.8010）时，踝肱指数（ABI）自基线的变化也无显著差异。JET+PCB组和PTA+PCB组从基线到3年时RCC改善一个或多个等级也无统计学差异（P=0.8949）。在整个3年随访期间，两组均未发生小截肢或大截肢。5例JET+PCB组患者在3年指定观察期前死亡，PTA+PCB组无死亡（P=0.137）。其中2例死亡归因于癌症，3例归因于心脏原因。均认为与器械或手术无关。JET+PCB组在3年随访时TLR的无事件生存率、ABI和RCC改善情况相似，两组在截肢或死亡率方面无差异。JET+PCB组有TLR减少的趋势。
