Midwest Cardiovascular Research Foundation, Davenport, IA, USA.
Vasc Health Risk Manag. 2023 Mar 11;19:133-137. doi: 10.2147/VHRM.S403177. eCollection 2023.
The JET-RANGER study (NCT03206762) was a multicenter (11 US centers) randomized trial, core lab adjudicated, designed to demonstrate the superiority of Jetstream + Paclitaxel coated balloon (JET+PCB) versus angioplasty (PTA) + PCB in treating femoropopliteal (FP) arterial disease. The one-year primary endpoint of JET-RANGER has been recently published. The 2-year outcome data are presented in this report.
There were 43 patients who completed the 1-year follow-up. Two were lost to follow-up and one died prior to the 2-year follow-up, resulting in 40 patients. Fifteen patients were randomized to PTA+PCB and 25 patients to JET +PCB. Kaplan Meier Survival analysis was performed to estimate the freedom from TLR. Bailout stenting was not considered a TLR in this analysis. Statistical significance was determined by a p-value < 0.05.
Freedom from TLR was similar between the 2 groups at 2 years. There was also no significant difference in the change of ABI between the PTA + PCB and JET + PCB from baseline at 6-months, (p-value = 0.7890), 1-year (p-value = 0.4070), and 2-year (p-value=0.7410). There was also no statistical difference between the JET + PCB and PTA + PCB arms for RCC improvement by one or more category, (p-value= 1.000). There were no minor or major amputations for either arm throughout the 2-year follow up. One JET + PCB patient died before the 2-year specified window.
JET + PCB had similar freedom from TLR and improvement in ABI and RCC at 2-year follow-up when compared to PTA + PCB with no difference in amputation or mortality between the 2 arms.
NCT03206762.
JET-RANGER 研究（NCT03206762）是一项多中心（美国 11 个中心）随机试验，由核心实验室裁决，旨在证明 Jetstream+紫杉醇涂层球囊（JET+PCB）在治疗股腘动脉疾病方面优于经皮腔内血管成形术（PTA）+PCB。JET-RANGER 的一年主要终点最近已经公布。本报告介绍了 2 年的结果数据。
有 43 名患者完成了 1 年的随访。2 人失访，1 人在 2 年随访前死亡，因此有 40 名患者。15 名患者被随机分配到 PTA+PCB 组，25 名患者被分配到 JET+PCB 组。采用 Kaplan-Meier 生存分析估计 TLR 无复发率。在这项分析中，紧急支架置入术不被视为 TLR。统计学意义由 p 值<0.05 确定。
两组患者在 2 年时 TLR 无复发率相似。在 6 个月（p 值=0.7890）、1 年（p 值=0.4070）和 2 年（p 值=0.7410）时，PTA+PCB 和 JET+PCB 组之间的 ABI 变化也没有显著差异。JET+PCB 和 PTA+PCB 组的 RCC 改善一个或多个等级的比例也没有统计学差异（p 值=1.000）。在整个 2 年的随访过程中，两支手臂均无小截肢或大截肢。一名 JET+PCB 患者在 2 年规定的窗口期前死亡。
与 PTA+PCB 相比，JET+PCB 在 2 年随访时 TLR 无复发率和 ABI 和 RCC 改善情况相似，两支手臂之间的截肢率或死亡率没有差异。
NCT03206762。
