TITLE: Single-Center Prospective Pilot Study of Sirolimus Drug-Coated Balloon Angioplasty in Maintaining the Patency of Thrombosed Arteriovenous Graft.

PURPOSE: To investigate the use of a sirolimus drug-coated balloon (DCB) in the management of a thrombosed arteriovenous graft (AVG).

MATERIALS AND METHODS: A single-center prospective pilot study was conducted between October 2018 and October 2019. Twenty patients (age = 67.0 years ± 10; male = 35%; mean time on dialysis = 31 months) with thrombosed upper limb AVG were enrolled. After successful pharmacomechanical thrombectomy and adequate treatment of the graft vein junction, sirolimus DCB angioplasty was performed at the graft vein junction. The patients were followed-up for 6 months, and all adverse events occurring during the study period were recorded.

RESULTS: The primary circuit patency rates at 3 and 6 months were 76% and 65%, respectively, while the assisted-primary circuit patency rates at 3 and 6 months were 82% and 65%, respectively. The 3- and 6-month secondary circuit patency rates were 88% and 76%, respectively. Using Kaplan-Meier analyses, the estimated mean primary, assisted-primary, and secondary patencies were 285 days (95% confidence interval (CI) = 194-376 days), 319 days (95% CI = 221-416 days), and 409 days (95% CI = 333-485 days). No adverse event directly related to sirolimus DCB use was observed.

CONCLUSIONS: The results of this pilot study suggest that the application of sirolimus DCB at the graft vein junction after the successful thrombectomy of AVG may be a feasible option to improve patency outcomes.

SOURCE: Tan CW, Tan RY, Pang SC, et al. Single-Center Prospective Pilot Study of Sirolimus Drug-Coated Balloon Angioplasty in Maintaining the Patency of Thrombosed Arteriovenous Graft. J Vasc Interv Radiol. 2021. 32(3): 369-375. 

目的：研究西罗莫司药物涂层球囊（DCB）在血栓性动静脉移植物（AVG）管理中的应用。

材料与方法：于2018年10月至2019年10月进行了单中心前瞻性研究。研究入选了20名血栓性上肢AVG患者（年龄= 67.0±10岁；男性= 35％；平均透析时间= 31个月）。在成功进行了药物机械血栓切除术并适当治疗了移植物静脉连接处之后，在移植物静脉连接处进行了西罗莫司DCB血管成形术。对患者进行了6个月的随访，并记录了研究期间发生的所有不良事件。

结果：3个月和6个月时的初次通路通畅率分别为76％和65％，而3个月和6个月时的辅助初期通路通畅率分别为82％和65％。 3个月和6个月的二期通路通畅率分别为88％和76％。使用Kaplan-Meier分析，估计的平均初期，辅助初期和二期通畅为285天（95％置信区间（CI）= 194-376天），319天（95％置信区间= 221-416天）和409天（95％CI = 333-485天）。没有观察到与西罗莫司DCB使用直接相关的不良事件。

结论：这项初步研究的结果表明，西罗莫司DCB在成功行AVG血栓切除术后移植物静脉连接处的应用可能是改善通畅结局的可行选择。

启发：移植物静脉连接处的问题一直是困扰我们，药物球囊提供了一个可行的选择，效果还待提高！