Martens Jasper M, Knippenberg Bob, Vos Jan-Albert, de Vries Jean-Paul P, Hansen Bettina E, van Overhagen Hans
Department of Radiology, Haga Teaching Hospital, The Hague, The Netherlands.
J Vasc Surg. 2009 Sep;50(3):687-9. doi: 10.1016/j.jvs.2009.04.073.
The Percutaneous transluminal Angioplasty and Drug eluting stents for Infrapopliteal lesions in critical limb ischemia (PADI) trial is a prospective, multicenter, randomized, controlled, double-arm study investigating the safety and efficacy of primary paclitaxel-eluting stent implantation vs primary percutaneous transluminal angioplasty (PTA) in infrapopliteal lesions in critical limb ischemia (CLI). PTA with provisional "bailout" stent implantation is currently an accepted treatment for arterial obstructions in CLI, including those in below-the-knee arteries. A drawback compared to open bypass surgery is the relatively high restenosis rate. One proposed method to reduce restenosis is the use of drug-eluting stents (DES), as these have shown good results in the coronary bed. Primary DES implantation for focal obstructions in infrapopliteal arteries in CLI potentially reduces restenosis compared to PTA alone and may subsequently prolong effect of treatment, allowing for better wound healing, and preventing recurrence of symptoms. In this article, we report on rationale, design, and progress of the PADI trial, which investigates the safety and efficacy of a paclitaxel-eluting stent system compared to PTA with provisional bare metal stent implantation.
下肢严重缺血病变经皮腔内血管成形术及药物洗脱支架置入术（PADI）试验是一项前瞻性、多中心、随机、对照、双臂研究，旨在调查在下肢严重缺血（CLI）的腘下病变中，原发性紫杉醇洗脱支架植入术与原发性经皮腔内血管成形术（PTA）的安全性和有效性。目前，PTA联合临时“补救”支架植入术是CLI动脉阻塞（包括膝下动脉阻塞）的一种公认治疗方法。与开放旁路手术相比，一个缺点是再狭窄率相对较高。一种减少再狭窄的方法是使用药物洗脱支架（DES），因为这些支架在冠状动脉床已显示出良好效果。与单独的PTA相比，CLI患者腘下动脉局灶性阻塞的原发性DES植入术可能降低再狭窄率，随后可能延长治疗效果，促进更好的伤口愈合，并预防症状复发。在本文中，我们报告了PADI试验的原理、设计和进展，该试验调查了紫杉醇洗脱支架系统与PTA联合临时裸金属支架植入术相比的安全性和有效性。
