用包利塔塞尔涂层气球进行喷流动脉切除术:前性随机JET-RANGER研究的3年结果
Nicolas W Shammas1, Gail Shammas1, Sue Jones-Miller1
1Midwest Cardiovascular Research Foundation, Cardiovascular Research, Davenport, Iowa.
概括
在JET-RANGER研究中,没有发现Jetstream + 帕克利塔塞尔涂层气球 (JET+PCB) 和皮肤透光血管造形术 + 帕克利塔塞尔涂层气球 (PTA+PCB) 在3年内对于股骨动脉疾病的目标损伤再血管化 (TLR) 的自由有显著差异.
科学领域:
- 血管外科 血管外科
- 干预心脏病学 干预心脏病学
- 医疗器械 医疗器械
背景情况:
- 雌雄关节动脉疾病在治疗和肢体救援方面带来了重大挑战.
- 涂有帕克利塔塞尔的气球 (PCB) 用于改善外周动脉疾病的结果.
- JET-RANGER研究旨在评估这种患者群体中的新型设备.
研究的目的:
- 为了比较Jetstream + 帕克利塔塞尔涂层气球 (JET+PCB) 与皮肤透光血管整形 + 帕克利塔塞尔涂层气球 (PTA+PCB) 在治疗股骨动脉疾病的3年结果.
- 评估目标损伤再血管化 (TLR) 的自由度,脚-手臂指数 (ABI) 的变化以及拉瑟福分类 (RCC) 评分.
主要方法:
- 一个多中心的随机试验 (JET-RANGER研究) 涉及47名患有48个病变的患者.
- 患者被随机分配到JET+PCB或PTA+PCB手臂,比例为2:1.
- 使用Kaplan-Meier生存分析来确定3年后没有TLR,统计学意义为p < 0.05.
主要成果:
- 在JET+PCB (88.0%) 和PTA+PCB (67.8%) 组 (p=0.1380) 中,3年后无TLR的情况相似.
- 在3年后,在两组之间ABI或RCC改善的变化中没有观察到显著差异.
- 两只手臂都没有截肢;然而,在JET+PCB手臂报告了五例死亡 (两例癌症,三例心脏病),与设备或手术无关.
结论:
- 在3年随访后,JET+PCB在无TLR,ABI和RCC改善方面表现出与PTA+PCB相似的疗效.
- 该研究发现,两种治疗手臂之间截肢或死亡率没有显著差异.
- 在JET+PCB手臂中观察到较少TLR的趋势,需要进一步调查.
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