Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease

• Published in: The New England journal of medicine Vol. 373; no. 2; pp. 145 - 153
• Main Authors: Rosenfield, Kenneth, Jaff, Michael R, White, Christopher J, Rocha-Singh, Krishna, Mena-Hurtado, Carlos, Metzger, D. Christopher, Brodmann, Marianne, Pilger, Ernst, Zeller, Thomas, Krishnan, Prakash, Gammon, Roger, Müller-Hülsbeck, Stefan, Nehler, Mark R, Benenati, James F, Scheinert, Dierk
• Format: Journal Article
• Language: English
• Published: United States Massachusetts Medical Society 09.07.2015
• Subjects: Aged; Amputation; Angioplasty; Angioplasty, Balloon - adverse effects; Angioplasty, Balloon - instrumentation; Arteriosclerosis; Balloon treatment; Cardiovascular diseases; Coatings; Death; Diabetes Complications - therapy; Diabetes mellitus; Drug dosages; Female; Femoral Artery - diagnostic imaging; Humans; Ischemia; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Paclitaxel - administration & dosage; Pain; Patients; Peripheral Arterial Disease - mortality; Peripheral Arterial Disease - therapy; Popliteal Artery - diagnostic imaging; Radiography; Restenosis; Safety; Single-Blind Method; Smoking; Stents; Thrombosis; Vascular diseases; Vascular Patency; Vein & artery diseases; Veins & arteries; United States > US; Massachusetts
• ISSN: 0028-4793; 1533-4406; 1533-4406
• DOI: 10.1056/NEJMoa1406235

In this trial, patients with femoropopliteal artery disease were assigned to standard angioplasty or treatment with a paclitaxel-coated balloon. At 12 months, primary patency was seen more frequently with the drug-coated balloon than with standard angioplasty. Atherosclerotic disease in the femoral and popliteal (femoropopliteal) arteries compromises perfusion to the legs and feet. Although treatment with percutaneous transluminal angioplasty is effective in initially restoring blood flow, restenosis from vessel recoil and neointimal hyperplasia occur in more than 60% of patients within 1 year after the procedure. 1 Stents act as scaffolds to prevent recoil and reduce the incidence of restenosis, 2 – 9 but the permanent presence of an intravascular prosthesis may limit subsequent therapeutic options. Stent fracture, although infrequent, can have negative consequences. 10 – 13 Results with drug-eluting stents in peripheral vessels have varied, 14 – 18 although a recent study showed . . .