Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial.
BACKGROUND
The success of percutaneous intervention in peripheral arterial disease is limited by restenosis. The aim of the present pilot study was to evaluate a novel method of local drug delivery.


RESULTS
This randomized multicenter study with blinded reading enrolled 87 patients in Rutherford class 1 to 4 with occlusion or hemodynamically relevant stenosis, restenosis, or in-stent restenosis of femoropopliteal arteries. Treatment was performed by either conventional uncoated or paclitaxel-coated balloon catheters. The primary end point was late lumen loss at 6 months. Secondary end points included restenosis rate, ankle brachial index, Rutherford class, target lesion revascularization, and tolerance up to >18 months. Before intervention, there were no significant differences in lesion characteristics such as reference diameter (5.3+/-1.1 versus 5.2+/-1.0 mm), degree of stenosis (84+/-11% versus 84+/-16%), proportion of restenotic lesions (36% versus 33%), and mean lesion length (5.7 cm [0.8 to 22.6 cm] versus 6.1 cm [0.9 to 19.3 cm]) between treatment groups. The 6-month follow-up angiography performed in 31 of 45 and 34 of 42 patients showed less late lumen loss in the coated balloon group (0.5+/-1.1 versus 1.0+/-1.1 mm; P=0.031). The number of target lesion revascularizations was lower in the paclitaxel-coated balloon group than in control subjects (3 of 45 versus 14 of 42 patients; P=0.002). Improvement in Rutherford class was greater in the coated balloon group (P=0.045), whereas the improvement in ankle brachial index was not different. The difference in target lesion revascularizations between treatment groups was maintained up to >18 months. No adverse events were assessed as related to balloon coating.


CONCLUSIONS
In this pilot trial, paclitaxel balloon coating caused no obvious adverse events and reduced restenosis in patients undergoing angioplasty of femoropopliteal arteries.
Werk
Michael
M
Charité, Universitätsmedizin Berlin, Martin-Luther-Krankenhaus, Department of Radiology, Berlin, Germany. m.werk@mlk-berlin.de
Langner
Soenke
S
Reinkensmeier
Bianka
B
Boettcher
Hans-Frank
HF
Tepe
Gunnar
G
Dietz
Ulrich
U
Hosten
Norbert
N
Hamm
Bernd
B
Speck
Ulrich
U
Ricke
Jens
J
D000368:Aged; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000379:methods*; D020099:Coated Materials, Biocompatible; D018572:Disease-Free Survival; D016503:Drug Delivery Systems; D005260:Female; D005263:Femoral Artery; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D017239:Paclitaxel; D016491:Peripheral Vascular Diseases / Q000628:therapy*; D010865:Pilot Projects; D011150:Popliteal Artery; D012008:Recurrence; D016896:Treatment Outcome
D020099:Coated Materials, Biocompatible; D017239:Paclitaxel