Four-year outcomes of a single-center experience with coronary everolimus-eluting bioresorbable scaffolds.

Abstract

BACKGROUND\nBioresorbable scaffolds (BRS) have been introduced to overcome the limitations of drug-eluting stents and the ABSORB (Everolimus-eluting BRS, Abbott Vascular, Santa Clara, CA) was the most extensively tested. Nevertheless, major RCTs reported higher rates of target lesion failures and BRS thrombosis at 3 years follow-up, bringing to the withdrawing of the device from the market. It has been suggested that a better lesions selection and an optimized implantation technique could mitigate the displayed adverse results.\n\n\nMETHODS\nConsecutive patients undergoing BRS implantation were included in this observational, single center study. Clinical follow-up was conducted up to 4 years. Endpoint of interest was the target lesion failure (TLF), a composite outcome including cardiac death, target vessel myocardial infarction and target lesion revascularization.\n\n\nRESULTS\nA total of 62 patients with a mean age of 55±8.5 years were analysed of which 70.9% presented with an acute coronary syndrome and 59.6% with myocardial infarction. A total of 100 lesions were treated and 51.6% were complex (B2/C). Predilatation was performed in all the case, post-dilatation in 74.1%. All the target vessel reference diameter (RVD) were > 2.5 mm (average RVD 3.2 ± 0.24 mm). At 4 years, the rate for TLF was 6.9%. Subgroups analysis did not show significative differences among groups although consistently higher event rates were found for RVD < 2.5 mm (12.6 vs 6.4% p 0.5), BRS overlapping (11.8 vs 5% p 0.2) and Ticagrelor instead of Clopidogrel on top of Cardioaspirin (9.1 vs 3% p 0.2).\n\n\nCONCLUSIONS\nThis small-sized real-world registry displays lower rates of clinical events during long-term follow-up in respect to previous studies. The avoidance of implantation in small vessels, inclusion of acute myocardial infarction and extensive performance of BRS post-dilatation could explain the observed better results. Long term outcomes of the ongoing ABSORB IV trial are needed to confirm this data.