Published Online
on September 8, 2008

A more recent version of this article appeared on September 23, 2008

This Article Full Text (PDF) CME: Take the course for this article: Circulation: September 23, 2008, Volume 118, Number 13 Correction Correction (v118,pe670) All Versions of this Article: 118/13/1358    most recent CIRCULATIONAHA.107.735985v1 Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Werk, M. Articles by Ricke, J. Search for Related Content PubMed PubMed Citation Articles by Werk, M. Articles by Ricke, J. Pubmed/NCBI databases Compound via MeSH Substance via MeSH Medline Plus Health Information Angioplasty Peripheral Arterial Disease Hazardous Substances DB TAXOL Related Collections Restenosis Restenosis Peripheral vascular disease Other Treatment Related Article

Submitted on August 23, 2007
Accepted on June 10, 2008

Inhibition of Restenosis in Femoropopliteal Arteries. Paclitaxel-Coated Versus Uncoated Balloon: Femoral Paclitaxel Randomized Pilot Trial

Michael Werk MD^*, Soenke Langner MD, Bianka Reinkensmeier MS, Hans-Frank Boettcher MD, Gunnar Tepe MD, Ulrich Dietz MD, Norbert Hosten MD, Bernd Hamm MD, Ulrich Speck PhD, and Jens Ricke MD

From Charité, Universitätsmedizin Berlin, Berlin (M.W., B.R., H.-F.B., B.H., U.S.); Universitätsklinikum Greifswald der Ernst-Moritz-Arndt-Universität, Greifswald (S.L., N.H.); Radiologische Klinik Universitätsklinikum Tübingen, Tübingen (G.T.); Deutsche Klinik für Diagnostik, Kardiologie, Wiesbaden (U.D.); and Klinik für Radiologie und Nuklearmedizin der Otto-von-Guericke-Universität Magdeburg, Magdeburg (J.R.), Germany.

^* To whom correspondence should be addressed. E-mail: m.werk{at}mlk-berlin.de.

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.

Methods and 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 (4 of 45 versus 14 of 42 patients; P=0.007). 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.

Key words: angioplasty • balloon • catheters • claudication • restenosis

Related Article:

Clinical Summaries
Circulation 2008 118: 1307-1308. [Extract] [Full Text]

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