New-generation drug-eluting stents in various patient populations

Abstract

Objectives:The aim of this study was to assess the 3-year safety and efficacy of treating all-comer patients with 3 contemporary drug-eluting stents (DES). Background:The BIO-RESORT (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population) (TWENTE III) randomized trial (NCT01674803) found similar 1-year safety and efficacy for the 2 biodegradablepolymer DES (i.e., ultrathin-strut cobalt-chromium Orsiro sirolimus-eluting stent [SES] and very-thin-strut platinum-chromium Synergy everolimus-eluting stent) compared with the durable-polymer thin-strut cobalt-chromium Resolute Integrity zotarolimuseluting stent (ZES). Two-year follow-up suggested that the SES might reduce repeat revascularizations beyond 1 year compared with the ZES.Methods: A total of 3,514 all-comer patients were treated at 4 centers for coronary intervention. The main clinical endpoint, target vessel failure, was a composite of safety (cardiac death or target vessel-related myocardial infarction) and efficacy (target vessel revascularization). Secondary endpoints included the individual components of target vessel failure and stent thrombosis.Results: Three-year follow-up data were available for 3,393 of 3,514 patients (96.6%).Target vessel failure occurred in 8.5% with SES and 10.0% with ZES (p log-rank = 0.22) and in 8.8% with everolimus-eluting stents (vs. ZES, p log-rank = 0.32). Rates of cardiac death, target vessel myocardial infarction, and target vessel revascularization were similar between stent groups. Landmark analyses found no statistically significant betweenstent difference in repeat revascularization between 1 and 3 years. Definite or probable stent thrombosis rates were low (SES, 1.1%; everolimus-eluting stent, 1.1%; ZES, 0.9%) and similar with all 3 DES. Conclusions: Despite substantial differences in stent backbone and polymer coating, all 3 DES showed favorable 3-year safety and efficacy in all comers, without significant between-stent differences. Further follow-up is required to definitely answer the question of whether one stent might improve clinical outcomes at a later stage. * This is the number of patients treated with drug-eluting stents during the period of study enrollment, irrespective of in-or exclusion criteria. Clinical endpoints, monitoring, and event adjudicationClinical endpoints were pre-specified, according to definitions of the Academic Research Consortium. 16,17 The main composite endpoint target vessel failure (TVF) assessed device efficacy and patient safety, including cardiac death, target-vessel related myocardial infarction (MI), or clinically indicated target vessel revascularization. Secondary endpoints were prespecified and included target lesion revascularization (TLR) and stent thrombosis, as well as individual components of several composite endpoints. The secondary composite endpoints were target lesion failure (TLF), comprising cardiac 03 Ultrathin-and very thin-strut biodegradable-polymer versus thin-strut durable-polymer drug-eluting stents fo...