Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg.
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].).
Tepe
Gunnar
G
Radiologische Klinik, Diagnostische und Interventionelle Radiologie, Eberhard-Karls-Universität, Tübingen, Germany. gunnar-tepe@med.uni-tuebingen.de
Zeller
Thomas
T
Albrecht
Thomas
T
Heller
Stephan
S
Schwarzwälder
Uwe
U
Beregi
Jean-Paul
JP
Claussen
Claus D
CD
Oldenburg
Anja
A
Scheller
Bruno
B
Speck
Ulrich
U
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon / Q000009:adverse effects; D001157:Arterial Occlusive Diseases / Q000188:drug therapy* / Q000473:pathology / Q000628:therapy; D003287:Contrast Media; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000473:pathology*; D005500:Follow-Up Studies; D006801:Humans; D007866:Leg / Q000098:blood supply; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000473:pathology*; D011859:Radiography; D055502:Secondary Prevention; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
D003287:Contrast Media; D017239:Paclitaxel