Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Sachar, R; Soga, Y; Ansari, MM; Kozuki, A; Lopez, L; Brodmann, M; Schroë, H; Ramanath, VS; Diaz-Cartelle, J; Zeller, T, , RANGER, II, SFA, Investigators.
1-Year Results From the RANGER II SFA Randomized Trial of the Ranger Drug-Coated Balloon.
JACC-CARDIOVASC INTE. 2021; 14(10): 1123-1133.
Doi: 10.1016/j.jcin.2021.03.021
Web of Science
PubMed
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FullText_MUG
- Co-Autor*innen der Med Uni Graz
- Brodmann Marianne
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- Abstract:
- OBJECTIVES: This study sought to evaluate the safety and effectiveness of the Ranger drug-coated balloon (DCB) (paclitaxel dose density 2 μg/mm2) for treating superficial femoral artery or proximal popliteal artery lesions. BACKGROUND: Paclitaxel-coated balloon treatment prevents reinterventions, but dose and coating characteristics differ among balloons and necessitate discrete confirmation of safety and effectiveness. METHODS: Patients with symptomatic lower limb ischemia (Rutherford classification 2 to 4) were randomized 3:1 to treatment with the Ranger DCB or standard percutaneous transluminal angioplasty (PTA). Twelve-month primary target lesion patency, freedom from major adverse events (i.e., target lesion revascularization, major amputations, death within 1 month of the index procedure), and patient outcomes were analyzed. RESULTS: Mean lesion length was 82.5 ± 48.9 mm for the Ranger DCB group (n = 278) and 79.9 ± 49.3 mm for the control group (n = 98). Ranger DCB was superior to PTA (82.9% [n = 194 of 234] vs. 66.3% [n = 57 of 86]) with observed 12-month primary patency rates yielding a difference of 16.6% (95% confidence interval: 5.5% to 27.7%; p = 0.0013). Noninferior freedom from major adverse events (94.1% [n = 241 of 256] vs. 83.5% [n = 76 of 91]) was demonstrated with a difference of 10.6% (95% confidence interval: 2.5% to 18.8%; noninferiority p < 0.0001). Primary patency rate curves showed significant separation by Kaplan-Meier analysis (log-rank p = 0.0005), with rates of 89.8% and 74.0% estimated at day 365 for the Ranger DCB and PTA cohorts, respectively. CONCLUSIONS: The low-dose Ranger DCB demonstrated significantly better effectiveness than standard PTA through 1 year and a good safety profile. (Ranger™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty [RANGER II SFA]; NCT03064126).
- Find related publications in this database (using NLM MeSH Indexing)
- Angioplasty, Balloon - adverse effects
- Coated Materials, Biocompatible - administration & dosage
- Femoral Artery - diagnostic imaging
- Humans - administration & dosage
- Paclitaxel - adverse effects
- Peripheral Arterial Disease - diagnostic imaging, therapy
- Pharmaceutical Preparations - administration & dosage
- Popliteal Artery - diagnostic imaging
- Prospective Studies - administration & dosage
- Time Factors - administration & dosage
- Treatment Outcome - administration & dosage
- Vascular Patency - administration & dosage
- Find related publications in this database (Keywords)
- drug-coated balloon
- paclitaxel
- peripheral arterial disease
- superficial femoral artery
- vascular patency