Ramon L Varcoe1, Olaf Schouten2, Shannon D Thomas3, Andrew F Lennox4. 1. Department of Vascular Surgery, Prince of Wales Hospital, Sydney, Australia; Faculty of Medicine, University of New South Wales, Sydney, Australia; The Vascular Institute, Prince of Wales, Sydney, Australia. Electronic address: r.varcoe@unsw.edu.au. 2. Department of Vascular Surgery, Prince of Wales Hospital, Sydney, Australia; Department of Surgery, Reinier de Graaf Hospital, Delft, the Netherlands. 3. Department of Vascular Surgery, Prince of Wales Hospital, Sydney, Australia; Faculty of Medicine, University of New South Wales, Sydney, Australia; The Vascular Institute, Prince of Wales, Sydney, Australia. 4. Department of Vascular Surgery, Prince of Wales Hospital, Sydney, Australia; The Vascular Institute, Prince of Wales, Sydney, Australia.
Abstract
OBJECTIVES: The aim of this study was to investigate the midterm performance of an everolimus-eluting, bioresorbable vascular scaffold (Absorb, Abbott Vascular, Santa Clara, California) for the treatment of focal tibial and distal popliteal lesions. BACKGROUND: Drug-eluting stents are used below the knee to improve technical success and durability, but the ongoing presence of a permanent metal scaffold may have deleterious effects on the local vessel. METHODS: Tibial and distal popliteal angioplasty with scaffold placement was performed using an everolimus-eluting, bioresorbable scaffold (Absorb). Clinical and ultrasound follow-up was performed at 1, 3, 6, 12, and 24 months to detect binary restenosis and evaluate safety, restenosis, and clinical improvement. RESULTS: Thirty-eight limbs in 33 patients were treated for critical limb ischemia (68.4%) or severe claudication (31.6%). Fifty scaffolds were used to treat a total of 43 lesions, with a mean length of 19.2 ± 11.6 mm. During a mean follow-up period of 12.0 ± 3.9 months, 5 patients died, and all others were available for follow-up. Among the 38 treated limbs, clinical improvement was present in 30 (79%). Binary restenosis was detected in 3 of 50 scaffolds (6%). Using the Kaplan-Meier method, rates of primary patency were 96% and 84.6% at 12 and 24 months, respectively, and rates of freedom from clinically driven target lesion revascularization were 96% and 96% at 12 and 24 months, respectively. Complete wound healing occurred in 64% of those treated for tissue loss, with no major amputation and a limb-salvage rate of 100%. CONCLUSIONS: Twelve-month follow-up demonstrated excellent safety, patency, and freedom from target lesion revascularization using the Absorb bioresorbable vascular scaffold below the knee.
OBJECTIVES: The aim of this study was to investigate the midterm performance of an everolimus-eluting, bioresorbable vascular scaffold (Absorb, Abbott Vascular, Santa Clara, California) for the treatment of focal tibial and distal popliteal lesions. BACKGROUND: Drug-eluting stents are used below the knee to improve technical success and durability, but the ongoing presence of a permanent metal scaffold may have deleterious effects on the local vessel. METHODS: Tibial and distal popliteal angioplasty with scaffold placement was performed using an everolimus-eluting, bioresorbable scaffold (Absorb). Clinical and ultrasound follow-up was performed at 1, 3, 6, 12, and 24 months to detect binary restenosis and evaluate safety, restenosis, and clinical improvement. RESULTS: Thirty-eight limbs in 33 patients were treated for critical limb ischemia (68.4%) or severe claudication (31.6%). Fifty scaffolds were used to treat a total of 43 lesions, with a mean length of 19.2 ± 11.6 mm. During a mean follow-up period of 12.0 ± 3.9 months, 5 patients died, and all others were available for follow-up. Among the 38 treated limbs, clinical improvement was present in 30 (79%). Binary restenosis was detected in 3 of 50 scaffolds (6%). Using the Kaplan-Meier method, rates of primary patency were 96% and 84.6% at 12 and 24 months, respectively, and rates of freedom from clinically driven target lesion revascularization were 96% and 96% at 12 and 24 months, respectively. Complete wound healing occurred in 64% of those treated for tissue loss, with no major amputation and a limb-salvage rate of 100%. CONCLUSIONS: Twelve-month follow-up demonstrated excellent safety, patency, and freedom from target lesion revascularization using the Absorb bioresorbable vascular scaffold below the knee.
Authors: Leila Haghighat; Sophia Elissa Altin; Robert R Attaran; Carlos Mena-Hurtado; Christopher J Regan Journal: J Clin Med Date: 2018-04-14 Impact factor: 4.241