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Schulte, KL; Pilger, E; Schellong, S; Tan, KT; Baumann, F; Langhoff, R; Torsello, G; Zeller, T; Amendt, K; Brodmann, M; EXPAND Investigators.
Primary Self-EXPANDing Nitinol Stenting vs Balloon Angioplasty With Optional Bailout Stenting for the Treatment of Infrapopliteal Artery Disease in Patients With Severe Intermittent Claudication or Critical Limb Ischemia (EXPAND Study).
J Endovasc Ther. 2015; 22(5):690-697 Doi: 10.1177/1526602815598955
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Co-authors Med Uni Graz
Brodmann Marianne
Pilger Ernst
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Abstract:
To compare primary placement of a self-expanding nitinol stent to percutaneous transluminal angioplasty (PTA) with bailout stenting in infrapopliteal arteries of patients with severe intermittent claudication or critical limb ischemia (CLI). In the EXPAND trial (ClinicalTrials.gov; identifier NCT00906022), 92 patients (mean age 72.9±9.5 years; 62 men) undergoing treatment for infrapopliteal stenosis in 11 European centers were randomized 1:1 to either self-expanding nitinol stenting with the Astron Pulsar/Pulsar-18 nitinol stent or PTA with bailout stenting. The primary endpoint was sustainable clinical improvement after 12 months, defined as a ≥1-category increase for Rutherford category 3 patients or a ≥2-category increase for CLI patients (Rutherford categories 4/5) compared with baseline. Furthermore, target lesion revascularization (TLR), mortality, and amputation were assessed after 12 months. Sustained clinical improvement at 1 year was observed in 74.3% of the patients treated with primary stenting and in 68.6% of the patients treated with PTA and bailout stenting (p>0.05). Kaplan-Meier estimates of freedom from TLR (76.6% and 77.6%), mortality (7.4% vs 2.1%), and amputation [8.9% (major 6.7%) vs 13.2% (major 8.7%)] at 1 year were not significantly different. Primary self-expanding nitinol stenting did not show statistically different clinical outcomes compared to angioplasty with bailout stenting for infrapopliteal lesions. © The Author(s) 2015.
Find related publications in this database (using NLM MeSH Indexing)
Aged -
Aged, 80 and over -
Alloys -
Amputation -
Angioplasty, Balloon - adverse effects
Angioplasty, Balloon - instrumentation
Angioplasty, Balloon - mortality
Critical Illness -
Disease Progression -
Disease-Free Survival -
Endovascular Procedures - adverse effects
Endovascular Procedures - instrumentation
Endovascular Procedures - mortality
Europe -
Female -
Humans -
Intermittent Claudication - diagnosis
Intermittent Claudication - mortality
Intermittent Claudication - physiopathology
Intermittent Claudication - therapy
Ischemia - diagnosis
Ischemia - mortality
Ischemia - physiopathology
Ischemia - therapy
Kaplan-Meier Estimate -
Limb Salvage -
Male -
Middle Aged -
Peripheral Arterial Disease - diagnosis
Peripheral Arterial Disease - mortality
Peripheral Arterial Disease - physiopathology
Peripheral Arterial Disease - therapy
Popliteal Artery - physiopathology
Prospective Studies -
Prosthesis Design -
Recurrence -
Risk Assessment -
Risk Factors -
Stents -
Time Factors -
Treatment Outcome -
Vascular Patency -

Find related publications in this database (Keywords)
peripheral artery disease
bailout stenting
primary stenting
infrapopliteal lesions
nitinol stent
self-expanding stent
critical limb ischemia
below-the-knee interventions
mortality
amputation
target lesion revascularization
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