Treatment of femoropopliteal atherosclerotic lesions using the ranger paclitaxel-coated balloon catheter: 12-month results from an all-comers registry.

Details

Serval ID
serval:BIB_CF48490F2FC3
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Treatment of femoropopliteal atherosclerotic lesions using the ranger paclitaxel-coated balloon catheter: 12-month results from an all-comers registry.
Journal
The Journal of cardiovascular surgery
Author(s)
Lichtenberg M., von Bilderling P., Ranft J., Niemöller K., Grell H., Briner L., Saucy F., Rassaf T., Breuckmann F.
ISSN
1827-191X (Electronic)
ISSN-L
0021-9509
Publication state
Published
Issued date
02/2018
Peer-reviewed
Oui
Volume
59
Number
1
Pages
45-50
Language
english
Notes
Publication types: Clinical Trial ; Journal Article ; Multicenter Study ; Observational Study
Publication Status: ppublish
Abstract
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.
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.
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.
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.

Keywords
Aged, Angioplasty, Balloon/methods, Atherosclerosis/diagnostic imaging, Atherosclerosis/therapy, Female, Femoral Artery/diagnostic imaging, Follow-Up Studies, Germany, Hemodynamics, Humans, Male, Paclitaxel/administration & dosage, Peripheral Arterial Disease/diagnostic imaging, Peripheral Arterial Disease/therapy, Platelet Aggregation Inhibitors/therapeutic use, Popliteal Artery/diagnostic imaging, Prospective Studies, Registries, Stents, Switzerland, Treatment Outcome, Ultrasonography, Doppler, Duplex, Vascular Patency
Pubmed
Web of science
Create date
26/10/2017 8:32
Last modification date
20/08/2019 16:49
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