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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
Web of Science
PubMed
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FullText_MUG
- Co-authors Med Uni Graz
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Brodmann Marianne
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Pilger Ernst
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- Abstract:
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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.
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Aged -
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Aged, 80 and over -
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Alloys -
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Amputation -
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Angioplasty, Balloon - adverse effects
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Angioplasty, Balloon - instrumentation
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Angioplasty, Balloon - mortality
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Critical Illness -
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Disease Progression -
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Disease-Free Survival -
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Endovascular Procedures - adverse effects
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Endovascular Procedures - instrumentation
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Endovascular Procedures - mortality
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Europe -
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Female -
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Humans -
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Intermittent Claudication - diagnosis
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Intermittent Claudication - mortality
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Intermittent Claudication - physiopathology
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Intermittent Claudication - therapy
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Ischemia - diagnosis
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Ischemia - mortality
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Ischemia - physiopathology
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Ischemia - therapy
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Kaplan-Meier Estimate -
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Limb Salvage -
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Male -
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Middle Aged -
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Peripheral Arterial Disease - diagnosis
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Peripheral Arterial Disease - mortality
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Peripheral Arterial Disease - physiopathology
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Peripheral Arterial Disease - therapy
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Popliteal Artery - physiopathology
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Prospective Studies -
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Prosthesis Design -
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Recurrence -
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Risk Assessment -
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Risk Factors -
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Stents -
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Time Factors -
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Treatment Outcome -
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Vascular Patency -
- Find related publications in this database (Keywords)
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peripheral artery disease
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bailout stenting
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primary stenting
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infrapopliteal lesions
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nitinol stent
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self-expanding stent
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critical limb ischemia
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below-the-knee interventions
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mortality
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amputation
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target lesion revascularization