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THE JOURNAL OF CARDIOVASCULAR SURGERY

Rivista di Chirurgia Cardiaca, Vascolare e Toracica


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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


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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

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Publication History

Issue published online: November 28, 2017
Article first published online: October 3, 2017
Manuscript accepted: October 2, 2017
Manuscript received: October 1, 2017

Per citare questo articolo

Lichtenberg M, von Bilderling P, Ranft J, Niemöller K, Grell H, Briner L, et al. Treatment of femoropopliteal atherosclerotic lesions using the ranger paclitaxel-coated balloon catheter: 12-month results from an all-comers registry. J Cardiovasc Surg 2018;59:45-50. DOI: 10.23736/S0021-9509.17.10261-2

Corresponding author e-mail

klichte@gmx.net