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.