Sabine Steiner, Andrea Willfort-Ehringer, Horst Sievert, Volker Geist, Michael Lichtenberg, Costantino Del Giudice, Antoine Sauguet, Juan Diaz-Cartelle, Claudia Marx, Armin Ströbel, Ingolf Schult, Dierk Scheinert
- Objectives: The authors sought to evaluate the performance of the Ranger paclitaxel-coated balloon versus uncoated balloon angioplasty for femoropopliteal lesions at 12 months.
Background: Drug-coated balloons (DCBs) are a promising endovascular treatment option for peripheral artery disease of the femoropopliteal segment, and each unique device requires dedicated clinical study.
Methods: The prospective, randomized RANGER SFA (Comparison of the Ranger™ Paclitaxel-Coated PTA Balloon Catheter and Uncoated PTA Balloons in Femoropopliteal Arteries) study (NCT02013193) enrolled 105 patients with symptomatic lower limb ischemia (Rutherford category 2 to 4) and stenotic lesions in the nonstented femoropopliteal segment at 10 European centers. Seventy-one patients (mean age 68 ± 8 years, n = 53 men) were enrolled in the Ranger DCB arm, and 34 patients (mean age 67 ± 9 years, n = 23 men) were assigned to the control group. Twelve-month analysis included patency, safety, and clinical outcomes and quality-of-life assessments.
Results: The DCB group had a greater primary patency rate at 12 months (Kaplan-Meier estimate 86.4% vs. 56.5%), with a significantly longer time to patency failure (log-rank p < 0.001). The estimated freedom from target lesion revascularization rate was 91.2% in the DCB group and 69.9% in the control group at 12 months, with a significantly longer time to reintervention (p = 0.010). No target limb amputations or device-related deaths occurred in either group.
Conclusions: Twelve-month results show that patency was maintained longer after Ranger DCB treatment than after conventional balloon angioplasty, and this result was associated with a low revascularization rate and good clinical outcomes.
MetadatenAuthor: | Sabine Steiner, Andrea Willfort-Ehringer, Horst SievertGND, Volker Geist, Michael Lichtenberg, Costantino Del Giudice, Antoine Sauguet, Juan Diaz-Cartelle, Claudia Marx, Armin Ströbel, Ingolf Schult, Dierk Scheinert |
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URN: | urn:nbn:de:hebis:30:3-534165 |
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DOI: | https://doi.org/10.1016/j.jcin.2018.01.276 |
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ISSN: | 1876-7605 |
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ISSN: | 1936-8798 |
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Pubmed Id: | https://pubmed.ncbi.nlm.nih.gov/29730375 |
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Parent Title (English): | JACC Cardiovascular interventions |
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Publisher: | Elsevier ; American College of Cardiology |
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Place of publication: | New York, NY |
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Document Type: | Article |
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Language: | English |
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Year of Completion: | 2018 |
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Date of first Publication: | 2018/05/02 |
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Publishing Institution: | Universitätsbibliothek Johann Christian Senckenberg |
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Contributing Corporation: | RANGER SFA Investigators |
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Release Date: | 2020/04/27 |
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Tag: | drug-coated balloon; drug-eluting balloon; femoropopliteal segment; late lumen loss; paclitaxel; patency; peripheral artery disease; peripheral vascular diseases; popliteal artery; restenosis; stenosis; superficial femoral artery |
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Volume: | 11 |
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Issue: | 10 |
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Page Number: | 8 |
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First Page: | 934 |
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Last Page: | 941 |
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Note: | This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
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HeBIS-PPN: | 465976875 |
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Institutes: | Medizin / Medizin |
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Dewey Decimal Classification: | 6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit |
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Sammlungen: | Universitätspublikationen |
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Licence (German): | Creative Commons - Namensnennung-Nicht kommerziell - Keine Bearbeitung 4.0 |
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