TCT-650 Impact of the New BioMime™ Sirolimus-Eluting Stent in Comlex Patients of Daily Practice – Preliminary Results of the MeriT-2 Study

Abstract

Background:Overlapping first generation drug eluting stents (DES) have been demonstrated in preclinical models to show evidence of a persistent inflammatory response, fibrin deposition and delayed endothelialisation. The SIRTAX (Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization) Trial (nϭ1012) associated the implantation of overlapping first generation DES with impaired angiographic and adverse 3-year clinical outcomes, including death or myocardial infarction (MI). Methods: Patient level data from 5 controlled studies of the RESOLUTE Global Clinical Program evaluating the RESOLUTE zotarolimus-eluting stent (R-ZES) were pooled (nϭ5130). Enrolment criteria encompassed more complex patients, including acute MI, long lesions, unprotected left main, bifurcations, total occlusions, bypass grafts & visible thrombus. The position of the R-ZES in relation to the previous implanted stents during the index or staged procedures were reported by the study site as either 'separate,' 'abutting' or 'overlapping.' Comparisons of clinical outcomes -using propensity score adjustment of baseline anatomical and clinical characteristics -were undertaken between patients implanted with at least one overlapping DES against patients with no overlapping DES (Kaplan Meier analyses). Results: 644 of 5130 study patients (12.6%) underwent overlapping DES implantation. Baseline characteristics indicated that the implantation of overlapping DES compared to non-overlapping DES (nϭ4486) were performed more frequently in the RCA and in more complex coronary lesions. Thirty day, 1 & 2 year clinical outcomes indicated comparable all-cause death (2 year overlap vs. non overlap: 5.1% vs. 3.5%, pϭ0.13), cardiac death (3.0% vs. 2.1%, pϭ0.36), MACE (13.3% vs. 10.7%, pϭ0.19), target lesion (10.9% vs. 9.0%, pϭ0.41) & target vessel (12.8% vs. 10.6%, pϭ0.25) failure, and stent thrombosis (ARC definite/probable 1.4% vs. 0.9%, pϭ0.16). Conclusions: The adverse clinical outcomes associated with 1st generation DES were not apparent with 2nd generation DES. Overlapping second generation DES (compared to the non overlap) is safe & effective with comparable 2 year clinical outcomes, including repeat revascularisation.