A Polylactide Bioresorbable Scaffold Eluting Everolimus for Treatment of Culprit Lesions in ST-Segment Elevation Myocardial Infarction Patients: 3-Year Follow-up

Background: The first experiences with bioresorbable vascular scaffold (BRS) in STEMI patients showed that the implantation of this device during primary PCI (PPCI) is feasible and associated with encouraging early and mid-term efficacy outcomes. Since no long-term data are currently available, we sought to evaluate the 3-year outcomes following BRS implantation in the STEMI setting.

Methods: A multicenter prospective cohort analysis was performed on consecutive STEMI patients who underwent PPCI with BRS (ABSORB BVS) implantation (within the RAI Registry: NCT02298413). End-point of this analysis was the occurrence of a device oriented composite end-point (DOCE: cardiac death, target vessel myocardial infarction [TV-MI], ischemia-driven target lesion revascularization [ID-TLR]) at 36 months follow-up.

Results: Between December 2012 and February 2014, 1,232 STEMI patients underwent PPCI at the participating centers. Of these, 74 (6.0%) received a BRS, 18 (24.3%) of them were multiple and overlapping. Mean patient age was 54.4±10.5 years. Final TIMI 3 flow was obtained in 73 (98.6%) cases. Within 30 days follow-up 2 (2.7%) patients experienced a non fatal TV-MI due to sub-acute BRS thrombosis. Between 30 days and 36 months we reported: 1 (1.3%) non fatal TV-MI due to very late BRS thrombosis (16 months after the index procedure) and 2 (2.7%) ID-TLR (within 12 months). All the events were successfully managed with re-PCI. The DOCE at 36 months follow-up occurred in 6.7% of patients (5/74).

Conclusions: Our long-term follow-up in consecutive STEMI patients treated with BRS implantation shows that DOCE rate is relatively low. Larger studies are needed to better assess the potential influence of a pre-specified BRS implantation strategy on early, late and very late BRS failures in the challenging and appealing STEMI setting.