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Long‐term results of a prospective, single‐arm evaluation of everolimus‐eluting bioresorbable vascular scaffolds in infrapopliteal arteries
Author(s) -
Varcoe Ramon L.,
Menting Theo P.,
Thomas Shan D.,
Lennox Andrew F.
Publication year - 2021
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.29327
Subject(s) - medicine , restenosis , everolimus , prospective cohort study , claudication , revascularization , confidence interval , target lesion , thrombosis , surgery , stent , critical limb ischemia , urology , vascular disease , myocardial infarction , arterial disease , percutaneous coronary intervention
Objectives The aim of this study was to perform a long‐term evaluation of an everolimus eluting, bioresorbable vascular scaffold (BVS) in the treatment of de novo atherosclerotic disease within crural arteries. Methods A prospective, single‐arm study was performed enrolling patients with chronic lower limb ischemia between 2013 and 2018. Results Fifty‐five limbs in 48 patients (56% male; mean age 82.1 ± 8.0 years, range 65–97) were treated for critical limb ischemia (72.7%) or severe claudication (27.3%). Seventy‐one scaffolds were used to treat 61 lesions with a mean length of 20.1 ± 10.8 mm. During a mean follow‐up period of 35.2 ± 20.4 months, 22 (45.8%) patients had died. No late or very‐late scaffold thrombosis was observed. Overall, clinical improvement was observed in 90.9% and a limb‐salvage rate of 100% was observed. Binary restenosis was detected in 11/71(15.5%) scaffolds. Primary patency and freedom from clinically driven target lesion revascularization rates at 12, 24, 36, 48, and 60 months were 90.8% (95% confidence interval 80.7–95.8), 90.8% (80.7–95.8), 79.7% (65.8–88.4), 76.3% (61.1–86.2), 72.3% (55.5–83.4) and 97.2% (89.2–99.3), 97.2% (89.2–99.3), 90.7% (78.7–96.1), 90.7% (78.7–96.1), and 90.7% (78.7–96.1), respectively. Conclusions This long‐term study shows excellent rates of patency and freedom from target lesion revascularization using the absorb BVS below‐the‐knee. This proof of concept study lays the foundation for the next generation of BVS to be evaluated in infrapopliteal arteries.