JOURNAL TOOLS |
Publishing options |
eTOC |
To subscribe |
Submit an article |
Recommend to your librarian |
ARTICLE TOOLS |
Publication history |
Reprints |
Permissions |
Cite this article as |
Share |
YOUR ACCOUNT
YOUR ORDERS
SHOPPING BASKET
Items: 0
Total amount: € 0,00
HOW TO ORDER
YOUR SUBSCRIPTIONS
YOUR ARTICLES
YOUR EBOOKS
COUPON
ACCESSIBILITY
ORIGINAL ARTICLE GLOBAL PERSPECTIVES ON DRUG ELUTING BALLOON TECHNOLOGY AND SCIENCE Free access
The Journal of Cardiovascular Surgery 2018 February;59(1):45-50
DOI: 10.23736/S0021-9509.17.10261-2
Copyright © 2017 EDIZIONI MINERVA MEDICA
language: English
Treatment of femoropopliteal atherosclerotic lesions using the ranger paclitaxel-coated balloon catheter: 12-month results from an all-comers registry
Michael LICHTENBERG 1 ✉, Peter von BILDERLING 2, Jürgen RANFT 3, Kathrin NIEMÖLLER 3, Holger GRELL 4, Lucas BRINER 5, Françoise SAUCY 5, Tienush RASSAF 6, Frank BREUCKMANN 7
1 Klinik für Angiologie, Klinikum Arnsberg, Arnsberg, Germany; 2 Gefäßpraxis im Tal, München, Germany; 3 Klinik für Innere Medizin III, Knappschaftskrankenhaus Bottrop, Bottrop, Germany; 4 Abteilung Radiologie, Neuroradiologie, Sonographie und Nuklearmedizin, Krankenhaus der Barmherzigen Brüder Trier, Trier, Germany; 5 Department of Vascular Surgery, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland; 6 West German Heart and Vascular Center Essen, Department of Cardiology and Vascular Medicine, University Duisburg-Essen, Essen, Germany; 7 Department of Cardiology, Arnsberg Medical Center, Arnsberg, Germany
BACKGROUND: The aim of this study was to evaluate 12-month effectiveness of the endovascular treatment of femoropopliteal (FP) atherosclerotic lesions with the Ranger drug-coated balloon (DCB) in a real-world setting.
METHODS: In this prospective, observational, multicenter trial (ClinicalTrials.gov Identifier: NCT02462005) 172 consecutive patients with 226 de novo, restenosed, or reoccluded native superficial femoral and/or popliteal artery lesions were treated with the Ranger paclitaxel-coated balloon angioplasty. Mean lesion length was 129 mm (5-400 mm). Fifty-nine (26%) of 226 lesions were moderately or heavily calcified. Provisional stenting was conducted in 55 (22%) of 226 lesions. Main effectiveness outcomes were procedural success, 6- and 12-month hemodynamic or clinical improvement, and primary patency based and clinically driven target lesion revascularization (TLR) at 6 and 12 months.
RESULTS: Procedural success (<30% residual stenosis and no major adverse event within 30 days) was achieved in 126 (73%) of 172 patients with DCB alone and in all patients if bailout procedures were included. Primary patency was 91.0% at 6 months and 84.1% at 12 months. Freedom TLR was 92.4% at 6 months and 89.2% at 12 months. ABI, pain-free walking distance and Rutherford category improved significantly (P<0.001) after 6 and 12 months.
CONCLUSIONS: Results suggest that angioplasty with the Ranger paclitaxel-coated balloon with provisional stenting is efficacious for the treatment of a broad range of femoropopliteal atherosclerotic lesions. No safety concerns arose.
KEY WORDS: Endovascular procedures - Plaque, atherosclerotic - Angioplasty, balloon - Paclitaxel