Medizinische Universität Graz - Research portal
Selected Publication:
SHR Neuro Cancer Cardio Lipid Metab Microb
Thieme, M; Lichtenberg, M; Brodmann, M; Cioppa, A; Scheinert, D.
Lutonix® 014 DCB global Below the Knee Registry Study: interim 6-month outcomes.
J CARDIOVASC SURG. 2018; 59(2): 232-236.
Doi: 10.23736/S0021-9509.18.10269-2
[OPEN ACCESS]
Web of Science
PubMed
FullText
FullText_MUG
- Co-authors Med Uni Graz
- Brodmann Marianne
- Altmetrics:
- Dimensions Citations:
- Plum Analytics:
- Scite (citation analytics):
- Abstract:
- The most common clinical presentation of peripheral artery disease (PAD) comprises intermittent claudication (IC), but about one third of patients will progress to critical limb ischemia (CLI), characterized by rest pain and/or tissue loss, which is the most severe limb manifestation of PAD. Paclitaxel-coated balloons are well established for the endovascular treatment of femoropopliteal lesions in patients with IC and CLI. This ongoing multicenter registry study is exploring the role of the Lutonix® 014 drug-coated balloon (DCB) in the treatment of below-the-knee (BTK) arteries and CLI. Three hundred fourteen (314) patients were enrolled from 26 sites and 12 countries. The real-world patients represent those undergoing intervention for BTK arteries with the Lutonix® 014 DCB. The study had both, primary safety and primary efficacy endpoints. The primary safety endpoint was freedom at 30 days from BTK major adverse limb event (MALE) + perioperative death (POD). Primary efficacy was freedom from clinically driven target lesion reintervention (fTLR) at 6 months. Additional secondary endpoints related to safety were reported. The interim 6 months' results showed freedom from MALE and POD at 30 days of 98.6% and at 6 months (180 days) of 96.0%. Primary efficacy of fTLR at 6 months (180 days) was 87.9%. Safety related secondary endpoints at 6 months (180 days) showed freedom from all of the following: all cause death of 91.2%, above ankle amputation 97.1%, reintervention for thrombosis 95.2%, reintervention for distal embolization 100.0%, and target vessel revascularization of 88.0%. There were no unexpected device or drug related events reported. The interim 6-month outcomes demonstrate the safety and efficacy of the Lutonix® 014 DCB for the treatment of BTK arteries.
- Find related publications in this database (using NLM MeSH Indexing)
- Aged -
- Aged, 80 and over -
- Amputation -
- Angioplasty, Balloon - adverse effects
- Angioplasty, Balloon - instrumentation
- Angioplasty, Balloon - mortality
- Coated Materials, Biocompatible -
- Equipment Design -
- Europe -
- Female -
- Humans -
- Intermittent Claudication - diagnosis
- Intermittent Claudication - mortality
- Intermittent Claudication - physiopathology
- Intermittent Claudication - therapy
- Ischemia - diagnosis
- Ischemia - mortality
- Ischemia - physiopathology
- Ischemia - therapy
- Limb Salvage -
- Lower Extremity - blood supply
- Male -
- Middle Aged -
- Peripheral Arterial Disease - diagnosis
- Peripheral Arterial Disease - mortality
- Peripheral Arterial Disease - physiopathology
- Peripheral Arterial Disease - therapy
- Prospective Studies -
- Registries -
- Risk Factors -
- Time Factors -
- Treatment Outcome -
- Vascular Access Devices -
- Vascular Patency -
- Find related publications in this database (Keywords)
- Angioplasty, balloon
- Atherosclerosis
- Device approval
- Paclitaxel