Interventional Cardiology and Peripheral Vascular Disease, South Baldwin Regional Medical Center, Foley, Alabama.
Interventional Cardiology and Peripheral Vascular Disease, Cardiovascular Institute of the South, Houma, Louisiana.
Catheter Cardiovasc Interv. 2020 Aug;96(2):393-401. doi: 10.1002/ccd.28739. Epub 2020 Feb 4.
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.
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.
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.
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.
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.
本研究旨在探讨使用新型局部输送紫杉醇的药物输送导管治疗下肢动脉病变的安全性和可行性。
球囊血管成形术目前是治疗膝下疾病的金标准；然而，经皮血管再通手术后，再狭窄仍然是一个巨大的挑战。
Occlusion Perfusion Catheter for Optimal Delivery of Paclitaxel for the Prevention of Endovascular Restenosis (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 个参与中心招募了 35 名患者。1、3 和 6 个月的安全性终点是无血栓形成、目标肢体的主要截肢和目标肢体相关死亡。主要疗效终点是 6 个月时的初始通畅率和免于临床驱动的靶病变血运重建。
所有患者均能很好地耐受手术，无不良手术事件报告。35 名患者的平均病变长度为 112±81.2mm，病变长度范围为 20-286mm。6 个月随访时，初始通畅率为 89.3%，免于临床驱动的靶病变血运重建率为 96.4%。在 1、3 和 6 个月的随访期间，无患者出现血栓形成、目标肢体的主要截肢和目标肢体相关死亡。
这项多中心研究的结果表明，使用闭塞灌注导管可以安全有效地治疗下肢动脉病变。
