ORIGINAL ARTICLE  GLOBAL PERSPECTIVES ON DRUG ELUTING BALLOON TECHNOLOGY AND SCIENCE Free

The Journal of Cardiovascular Surgery 2018 February;59(1):45-50

DOI: 10.23736/S0021-9509.17.10261-2

Copyright © 2017 EDIZIONI MINERVA MEDICA

lingua: Inglese

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