|
|
 | |||||||||||||||||||||||||||||||||||||||||||||||||
 | |||||||||||||||||||||||||||||||||||||||||||||||||
| |||||||||||||||||||||||||||||||||||||||||||||||||
Background Drug-eluting stents reduce restenosis in coronary arteries, but clinical trials have failed to prove their efficacy in peripheral arteries. We investigated the use of paclitaxel-coated angioplasty balloons and paclitaxel dissolved in the angiographic contrast medium during angioplasty of the leg.
Methods In a small, multicenter trial, we randomly assigned 154 patients with stenosis or occlusion of a femoropopliteal artery to treatment with standard balloon catheters coated with paclitaxel, uncoated balloons with paclitaxel dissolved in the contrast medium, or uncoated balloons without paclitaxel (control). The primary end point was late lumen loss at 6 months.
Results The mean (±SD) age of the patients was 68±8 years, 24% were smokers, and 49% had diabetes. Twenty-seven percent of the lesions were total occlusions, and 36% were restenotic lesions. The mean lesion length was 7.4±6.5 cm. There were no significant differences in baseline characteristics between the groups. There were no adverse events attributable to the paclitaxel-coated balloons. At 6 months, the mean late lumen loss was 1.7±1.8 mm in the control group, as compared with 0.4±1.2 mm (P<0.001) in the group treated with paclitaxel-coated balloons and 2.2±1.6 mm (P=0.11) in the group treated with paclitaxel in the contrast medium. The rate of revascularization of target lesions at 6 months was 20 of 54 (37%) in the control group, 2 of 48 (4%) in the group treated with paclitaxel-coated balloons (P<0.001 vs. control), and 15 of 52 (29%) in the group treated with paclitaxel in the contrast medium (P=0.41 vs. control); at 24 months, the rates increased to 28 of 54 (52%), 7 of 48 (15%), and 21 of 52 (40%), respectively.
Conclusions Use of paclitaxel-coated angioplasty balloons during percutaneous treatment of femoropopliteal disease is associated with significant reductions in late lumen loss and target-lesion revascularization. No significant benefit is seen with the use of a paclitaxel-containing contrast medium. (ClinicalTrials.gov number, NCT00156624
[ClinicalTrials.gov]
.)
Source Information
From the Radiologische Klinik, Diagnostische und Interventionelle Radiologie, Eberhard-Karls-Universität, Tübingen (G.T., S.H., C.D.C.); Angiologie, Herz-Zentrum Bad Krozingen, Bad Krozingen (T.Z., U. Schwarzwälder); Radiologie, Charité, Universitätsmedizin, Berlin (T.A., A.O., U. Speck); and the Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Homburg/Saar (B.S.) — all in Germany; and C2RM, Lille, France (J.-P.B.).
Address reprint requests to Dr. Tepe at Diagnostische und Interventionelle Radiologie, Eberhard-Karls-Universität Tübingen, Hoppe-Seyler-Str. 3, D-72076 Tübingen, Germany, or at gunnar-tepe{at}med.uni-tuebingen.de.
Related Letters:
Local Paclitaxel Delivery in Peripheral Vascular Disease
Schillinger M., Minar E., Diehm N., Baumgartner I., Jüni P., Tepe G., Zeller T., Albrecht T.
Extract |
Full Text |
PDF
N Engl J Med 2008;
358:2406-2407, May 29, 2008.
Correspondence
This article has been cited by other articles:
HOME | SUBSCRIBE | SEARCH | CURRENT ISSUE | PAST ISSUES | COLLECTIONS | PRIVACY | TERMS OF USE | HELP | beta.nejm.org Comments and questions? Please contact us. The New England Journal of Medicine is owned, published, and copyrighted © 2009 Massachusetts Medical Society. All rights reserved. |
Previous
