A universal drug delivery catheter for the treatment of infrapopliteal arterial disease using liquid therapy
A universal drug delivery catheter for the treatment of infrapopliteal arterial disease using liquid therapy
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DOI：
10.1002/ccd.28739
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发表时间：
2020-02-04
影响因子：
2.3
通讯作者：
Walker, Craig
中科院分区：
文献类型：
--
作者：
Bunch, Frank;Nair, Pradeep;Walker, Craig
目的本研究的目的是探讨使用新型药物输送导管局部输送液体紫杉醇治疗腘窝下病变的安全性和可行性。背景球囊血管成形术是目前治疗膝下疾病的金标准。然而，在这些经皮血运重建手术之后，再狭窄仍然是一个巨大的挑战。 方法 用于最佳输送紫杉醇的闭塞灌注导管预防血管内再狭窄 (COPPER-A) 研究 - 膝下队列是一项前瞻性、非随机、多中心、可行性和安全性研究，在 11 个参与地点招募了 35 名患者。第 1、3 和 6 个月的安全终点是无血栓形成、目标肢体大截肢和目标肢体相关死亡。疗效终点是主要通畅性和 6 个月时不进行临床驱动的靶病灶血运重建。 结果 所有患者对手术的耐受性良好，没有不良手术事件的报告。接受治疗的 35 名患者的平均病灶长度为 112 +/- 81.2 mm，病灶长度范围为 20-286 mm。 6 个月随访时，初次通畅率为 89.3%，无需进行临床驱动的靶病变血运重建的率为 96.4%。在1、3和6个月的随访间隔中，没有患者出现血栓形成、目标肢体大截肢和目标肢体相关死亡。结论这项多中心研究的结果表明，使用闭塞灌注导管用液体紫杉醇可以安全有效地治疗腘下动脉。
Objective The objective of this study was to investigate the safety and feasibility of treating infrapopliteal lesions using a novel drug delivery catheter locally delivering liquid paclitaxel.Background Balloon angioplasty is currently the Gold Standard to treat below-the-knee disease; however, restenosis continues to be a great challenge following these percutaneous revascularization procedures.Methods The Occlusion Perfusion Catheter for Optimal Delivery of Paclitaxel for the Prevention of Endovascular Restenosis (COPPER-A) study-Below-the-Knee Cohort was a prospective, nonrandomized, multicenter, feasibility, and safety study that enrolled 35 patients at 11 participating sites. The safety endpoints at 1, 3, and 6 months were freedom from thrombosis, major amputation in the target limb and target limb related death. The efficacy endpoints were primary patency and freedom from clinically driven target lesion revascularization at 6 months.Results All patients tolerated the procedure well with no reports of adverse procedural events. Thirty-five patients were treated with a mean lesion length of 112 +/- 81.2 mm with the lesion length range of 20-286 mm. At 6-month follow-up, primary patency was 89.3% and freedom from clinically driven target lesion revascularization was 96.4%. No patients demonstrated thrombosis, major amputation in the target limb and target limb related death at the 1-, 3- and 6-months follow-up intervals.Conclusions The results of this multi-center study demonstrated that infrapopliteal arteries can be safely and effectively treated with liquid paclitaxel using the occlusion perfusion catheter.