Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Mustapha, JA; Brodmann, M; Geraghty, PJ; Saab, F; Settlage, RA; Jaff, MR; Lutonix BTK Study Investigators .
Drug-Coated vs Uncoated Percutaneous Transluminal Angioplasty in Infrapopliteal Arteries: Six-Month Results of the Lutonix BTK Trial.
J Invasive Cardiol. 2019; 31(8):205-211
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PubMed
- Co-Autor*innen der Med Uni Graz
- Brodmann Marianne
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- Abstract:
- We hypothesized that a drug-coated balloon (DCB) could improve treatment efficacy while maintaining safety when compared with percutaneous transluminal angioplasty (PTA) for the treatment of atherosclerotic infrapopliteal arterial lesions. A total of 442 patients with angiographically significant lesions were randomized (2:1) to DCB or PTA. The primary safety and efficacy endpoints were freedom from major adverse limb events and perioperative death (MALE-POD) at 30 days, and freedom from vessel occlusion, clinically driven target-lesion revascularization (CD-TLR), and above-ankle amputation measured at 6 months. Success was achieved if safety between groups was non-inferior (margin 12%), and efficacy was statistically significant either for the overall intention-to treat (ITT) or the proximal-segment DCB groups (ie, the proximal two-thirds of the below-knee arterial pathways). Freedom from MALE-POD for the DCB group (99.3%) was non-inferior to PTA (99.4%; non-inferiority P<.001). Proportional analysis of the primary efficacy endpoint was statistically significant for the proximal-segment DCB group (76%) vs PTA (62.9%; one-sided P<.01; Bayesian P-value for success of .0085) while not statistically significant for the overall ITT group (74.5% for DCB vs 63.5% for PTA; one-sided P=.02). Kaplan-Meier analyses demonstrated superior efficacy for DCB in both the overall ITT and proximal-segment groups at 6 months. Primary patency and CD-TLR, hypothesis-tested secondary endpoints, were also statistically better for the DCB group compared with PTA at 6 months (one-sided P<.025). DCB treatment for symptomatic infrapopliteal arterial lesions produced non-inferior safety at 30 days and a statistically significant difference in the primary efficacy endpoint when compared with PTA at 6 months.
- Find related publications in this database (using NLM MeSH Indexing)
- Aged -
- Angiography -
- Angioplasty - methods
- Coated Materials, Biocompatible -
- Female -
- Follow-Up Studies -
- Humans -
- Male -
- Paclitaxel - pharmacology
- Peripheral Arterial Disease - diagnosis
- Peripheral Arterial Disease - surgery
- Popliteal Artery - diagnostic imaging
- Popliteal Artery - surgery
- Prospective Studies -
- Time Factors -
- Treatment Outcome -
- Find related publications in this database (Keywords)
- drug-coated balloon angioplasty
- infrapopliteal disease
- paclitaxel-coated balloon
- percutaneous transluminal angioplasty
- peripheral artery disease
- peripheral vascular disease