Update on PADI trial: percutaneous transluminal angioplasty and drug-eluting stents for infrapopliteal lesions in critical limb ischemia.
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.
Martens
Jasper M
JM
Department of Radiology, Haga Teaching Hospital, The Hague, The Netherlands. j.m.martens@hagaziekenhuis.nl
Knippenberg
Bob
B
Vos
Jan-Albert
JA
de Vries
Jean-Paul P
JP
Hansen
Bettina E
BE
van Overhagen
Hans
H
D000800:Angioplasty, Balloon / Q000295:instrumentation*; D001157:Arterial Occlusive Diseases / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003251:Constriction, Pathologic; D016638:Critical Illness; D054855:Drug-Eluting Stents; D006801:Humans; D007511:Ischemia / Q000175:diagnosis / Q000209:etiology / Q000628:therapy*; D035002:Lower Extremity / Q000098:blood supply*; D008670:Metals; D009426:Netherlands; D017239:Paclitaxel / Q000008:administration & dosage*; D011150:Popliteal Artery / Q000473:pathology; D011446:Prospective Studies; D011474:Prosthesis Design; D012107:Research Design; D055502:Secondary Prevention; D015607:Stents; D016896:Treatment Outcome
D002317:Cardiovascular Agents; D008670:Metals; D017239:Paclitaxel