Objectives: The aim of this study was to evaluate very long-term results after unrestricted everolimus-eluting bioresorbable scaffolds (BRS) implantation.
Background: Previous randomized studies mainly included selected patients differing from those seen during daily routine and long-term data from all-comers registries are sparse.
Methods: Consecutive patients undergoing BRS implantation were included in this observational, single center study. Clinical follow-up was conducted up to 5 years. Endpoint of interest was the composite of target lesion failure (TLF), including target-vessel myocardial infarction and target lesion revascularization and cardiac death. Furthermore, ARC-defined scaffold thrombosis (ScT) were assessed.
Results: A total of 176 patients with a median age of 64 (55 - 72) years were analyzed, of which 59.6% presented an acute coronary syndrome. A total of 183 mainly complex lesions (55.8%) were treated. At 5 years, the rate for TLF was 21.6%. Definite or probable ScT rate was 4.1%. The rate of ScT within the first year was 2.8% and afterwards 1.2%. Notably, no ScT was seen later than 2 years.
Conclusions: Although this real-world registry displays high rates of clinical events during long-term follow-up, no ScT was seen after 2 years.
Keywords: ACS/NSTEMI; acute myocardial infarction/STEMI; bioabsorbable devices/polymers; bioabsorbable stent; coronary artery disease; drug-eluting stent.
© 2020 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals, Inc.