Midwest Cardiovascular Research Foundation, Davenport, IA, USA.
Atlantic Imaging, Galloway, NJ, USA.
J Endovasc Ther. 2021 Feb;28(1):107-116. doi: 10.1177/1526602820951916. Epub 2020 Sep 4.
To report the results of a study evaluating JetStream atherectomy for the treatment of in-stent restenosis (ISR).
The JetStream XC atherectomy device, a rotational cutter with aspiration capacity, was evaluated in a prospective, multicenter study (JET-ISR) of 60 patients (mean age 70.2±10.8 years; 40 men) with femoropopliteal ISR ( identifier NCT02730234). Lesion length was 19.9±13.5 cm; 33 (55%) were chronic total occlusions and 26 (45%) were TransAtlantic Inter-Society Consensus class D. No drug-bearing device was allowed, and stenting was performed only for bailout. Lesion characteristics and stent integrity were evaluated by an independent core laboratory. The primary endpoint was target lesion revascularization (TLR) at 6 months with bailout stenting considered as TLR. Secondary endpoints included TLR (without bailout stenting) and clinical patency (no restenosis or TLR) at 1 year. The Kaplan-Meier method was employed to evaluate time-to-event endpoints; estimates are given with 95% confidence interval (CI).
Bailout stenting was required in 6 of 60 limbs (10%). There were no stent fractures or deformities after atherectomy + adjunctive angioplasty reported by the core laboratory. Kaplan-Meier estimates of freedom from TLR at 6 months and 1 year were 79.3% (95% CI 68.9% to 89.8%) and 60.7% (95% CI 47.8% to 73.6%), respectively. When bailout stenting at the index procedure was not considered a TLR event, freedom from TLR estimates at 6 months and 1 year were 89.3% (95% CI 81.2% to 97.4%) and 66.8% (95% CI 54.3% to 74.2%), respectively. Clinical patency rates at 6 months and 1 year were 77.5% (31/40) and 51.7% (15/29), respectively.
JetStream atherectomy using the XC device and no drug-eluting devices is feasible, with good clinical patency and 1-year freedom from TLR.
报告一项评估 JetStream 旋切术治疗支架内再狭窄（ISR）的研究结果。
在一项前瞻性、多中心研究（JET-ISR）中，对 60 例（平均年龄 70.2±10.8 岁；40 例男性）股腘 ISR 患者（标识符 NCT02730234）使用 JetStream XC 旋切装置（一种带抽吸能力的旋转切割器）进行了评估。病变长度为 19.9±13.5cm；33 例（55%）为慢性完全闭塞，26 例（45%）为 TransAtlantic Inter-Society Consensus 分级 D。不允许使用载药装置，支架置入仅用于紧急情况。通过独立核心实验室评估病变特征和支架完整性。主要终点为 6 个月时的靶病变血运重建（TLR），紧急情况下的支架置入被视为 TLR。次要终点包括 1 年时的 TLR（无紧急情况下的支架置入）和临床通畅率（无再狭窄或 TLR）。采用 Kaplan-Meier 方法评估时间相关终点；估计值给出了 95%置信区间（CI）。
60 条肢体中有 6 条（10%）需要紧急支架置入。核心实验室报告旋切+辅助血管成形术后无支架断裂或变形。6 个月和 1 年时 TLR 无事件生存率的 Kaplan-Meier 估计值分别为 79.3%（95%CI 68.9%至 89.8%）和 60.7%（95%CI 47.8%至 73.6%）。当指数操作中不考虑紧急情况下的支架置入为 TLR 事件时，6 个月和 1 年时 TLR 无事件生存率的估计值分别为 89.3%（95%CI 81.2%至 97.4%）和 66.8%（95%CI 54.3%至 74.2%）。6 个月和 1 年时的临床通畅率分别为 77.5%（31/40）和 51.7%（15/29）。
使用 XC 装置的 JetStream 旋切术且不使用药物洗脱装置是可行的，具有良好的临床通畅率和 1 年无 TLR 生存率。
