TCT-411 Risk and timing of clinical events according to diabetic status of patients treated with Everolimus-Eluting Bioresorbable Vascular Scaffolds vs. Everolimus-Eluting stent: 2-Year results from a propensity score matched comparison of ABSORB EXTEND and SPIRIT trials

Abstract

CONCLUSION Preliminary analysis of intracoronary imaging at 4 months post-implantation suggests that there is improved vascular healing with BP-EES compared to BRS, as indicated by the presence of greater inflammation with BRS with CAS imaging. Four month results from the full patient cohort will be available for presentation for the first time at TCT 2016.BACKGROUND There are limited data dedicated to clinical outcomes of diabetic patients treated with bioresorbable scaffolds (BRS) at 2-year horizon. The aim of the present analysis is to compare the occurrence of clinical events in diabetics treated with the Absorb bioresorbable vascular scaffold (Absorb BVS; Abbott Vascular, Santa Clara, CA) versus everolimus-eluting metal stents (EES; XIENCE V; Abbott Vascular, Santa Clara, CA)METHODS The present study included 812 patients in the ABSORB EXTEND study in which a total of 215 diabetic patients were treated with Absorb BVS. In addition, 882 diabetic patients treated with EES in pooled data from the SPIRIT clinical program were used for comparison by applying propensity score matching using 29 different variables (217 pairs). The primary endpoint was ischemic driven (ID) major adverse cardiac events (ID-MACE), including cardiac death, myocardial infarction (MI), and ID target lesion revascularization (ID-TLR). RESULTSAfter 2 years, the ID MACE rate was 6.5% in the Absorb BVS vs. 8.9% in the XIENCE group (p¼0.40). There was no difference for allcause death (HR:0.73 [0.29,1.85]; p¼0.5028); cardiac death (HR 0.72 [0.19,2.70]; p¼0.63); all MI (HR:1.25 [0.47,3.36];p¼0.65); TVR (HR:0.95 [0.44,2.05]; p¼0.89) or definite/probable device thrombosis (HR: 1.43 [0.24,8.58]; p¼0.69).The diabetes status had impact on clinical outcomes for both devices, with higher MACE rate among insulin-requiring diabetics. The comparison between Absorb BVS and Xience V along time showed that for non-insulin treated diabetics there was no ID-MACE difference between the BRS and the EES from 0-30 days (P¼1.00); from 0-365 days (P¼0.71) and 0-730 days (P¼0.75). Also for insulinrequiring diabetics there was no ID-MACE difference from 0-30 days (P¼1.00); from 0-365 days (P¼1.00) and 0-730 days (P¼1.00).CONCLUSION In this largest ever patient-level pooled comparison on the treatment of diabetic patients with BRS out to two years, individuals treated with the Absorb BVS had similar rate of MACE as compared with diabetics treated with EES. CATEGORIES CORONARY: Bioresorbable Vascular Scaffolds TCT-412Long-term clinical outcomes after implantation of everolimuseluting bioresorbable vascular scaffold in patients with acute myocardial infarction. 24-month clinical follow-up of the BVS STEMI First Study

Long‐term clinical results of bioresorbable absorb scaffolds using the PSP‐technique in patients with and without diabetes

“…Patients suffering from coronary artery disease and diabetes mellitus have a well‐documented high risk of ischemic and thrombotic events . Preliminary data with use of BVS in diabetic patients showed encouraging results similar to patients without diabetes mellitus . This hope was probably nurtured by the idea of minimizing possible triggers for permanent vascular inflammation with the “leave nothing behind” strategy of bioresorbable scaffolding.…”