Karl-Ludwig Schulte1, Ernst Pilger2, Sebastian Schellong3, Kong Ten Tan4, Frederic Baumann5, Ralf Langhoff6, Giovanni Torsello7, Thomas Zeller8, Klaus Amendt9, Marianne Brodmann. 1. Vascular Center Berlin, SGK Behandlungszentrum, Berlin, Germany k-l.schulte@gefaesszentrum.berlin. 2. Department of Angiology, Medical University Graz, Austria. 3. Internal Medicine, Dresden-Friedrichstadt Hospital, Dresden, Germany. 4. Department of Medical Imaging, UHN Toronto General Hospital, Toronto, Ontario, Canada. 5. Miami Cardiac and Vascular Institute, Baptist Hospital, Miami, FL, USA. 6. Department of Angiology, St. Gertrauden Krankenhaus, Berlin, Germany. 7. Department of Vascular and Endovascular Surgery, University of Münster, Germany. 8. Department of Angiology, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Germany. 9. Internal Medicine, Diakonissenkrankenhaus Mannheim, Germany.
Abstract
PURPOSE: 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). METHODS: 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. RESULTS: 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. CONCLUSION:Primary self-expanding nitinol stenting did not show statistically different clinical outcomes compared to angioplasty with bailout stenting for infrapopliteal lesions.
RCT Entities:
PURPOSE: 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). METHODS: 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. RESULTS: 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. CONCLUSION: Primary self-expanding nitinol stenting did not show statistically different clinical outcomes compared to angioplasty with bailout stenting for infrapopliteal lesions.
Authors: Marie D Gerhard-Herman; Heather L Gornik; Coletta Barrett; Neal R Barshes; Matthew A Corriere; Douglas E Drachman; Lee A Fleisher; Francis Gerry R Fowkes; Naomi M Hamburg; Scott Kinlay; Robert Lookstein; Sanjay Misra; Leila Mureebe; Jeffrey W Olin; Rajan A G Patel; Judith G Regensteiner; Andres Schanzer; Mehdi H Shishehbor; Kerry J Stewart; Diane Treat-Jacobson; M Eileen Walsh Journal: Circulation Date: 2016-11-13 Impact factor: 29.690
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Authors: Charlie C-T Hsu; Gigi Nc Kwan; Dalveer Singh; John A Rophael; Chris Anthony; Mieke L van Driel Journal: Cochrane Database Syst Rev Date: 2018-12-08
Authors: Marie D Gerhard-Herman; Heather L Gornik; Coletta Barrett; Neal R Barshes; Matthew A Corriere; Douglas E Drachman; Lee A Fleisher; Francis Gerry R Fowkes; Naomi M Hamburg; Scott Kinlay; Robert Lookstein; Sanjay Misra; Leila Mureebe; Jeffrey W Olin; Rajan A G Patel; Judith G Regensteiner; Andres Schanzer; Mehdi H Shishehbor; Kerry J Stewart; Diane Treat-Jacobson; M Eileen Walsh Journal: Circulation Date: 2016-11-13 Impact factor: 29.690