TCT-575 Different Vessel Healing Patterns Following Delivery of Everolimus and Paclitaxel Eluted from Biodegradable Polymer Coated Stents Implanted in Porcine Coronary Arteries

Abstract

Background:The role of percutaneous coronary intervention (PCI) in the treatment of multivessel coronary artery disease (CAD) is still controversial and widely discussed. More liberal use of drug-eluting stents (DES) increased proportion of those patients undergoing PCI procedure, raising a need for more clinical evidence. The recent reported COMPARE II trial showed similar results of Biolimus-eluting Nobori stent (BES) and Everolimus-eluting Xience/Promus stent (EES) at 1-year in an all comers population. We aim to compare safety and efficacy outcomes in patients with multivessel CAD (a pre-specified study subset) treated with BES and EES in COMPARE II trial. Methods: COMPARE II trial is a large randomized, multicentre, non-inferiority trial with total of 2707 patients enrolled at 12 sites across Europe, randomized in 1:2 ratio to the treatment with BES and EES with similar 12 months dual antiplatelet therapy. Primary endpoint was the composite of cardiac death (CD), non-fatal myocardial infarction (MI) and target vessel revascularization (TVR). Results: Total of 683 patients with multivessel CAD have been enrolled in COMPARE II trial, 453 of which in BES and 230 in EES arm. There were no significant differences in baseline characteristics such as age (64.3 vs. 63.7; pϭ0.4), male gender (78.2% vs. 78.7%; pϭ0.9), or presence of diabetes mellitus (23.0% vs. 25.7%; pϭ0.4) in BES and EES arms respectively. The lesion length and reference diameters were also similar. At 12 months, rate of CD (1.1% vs 1.3%; pϭ1.0), MI (4.4% vs 5.7%; pϭ0.5), target lesion revascularization (4.2% vs 2.6%; pϭ0.4), TVR (5.7% vs 3.9; pϭ0.4), target lesion failure (6.8% vs 7.4%; pϭ0.9) and composite of CD, non-fatal MI and TVR (8.6% vs 9.1%; pϭ0.9) were similar in BES and EES arms, Definite and propable stent thrombosis rate up to 12-months was also not different (1.1% in BES vs 1.3% in EES arm; pϭ1.0). Conclusions: Although this substudy was not powered to detect differences between the two stents, the BES with biodegradable polymer, was found as safe and effective as the EES even in this challenging patients population. This adds valuable evidence about clinical outcomes with contemporary DES.Background: With the introduction of drug eluting stents (DES) in this decade, treatment of patients with STEMI with these devices has emerged as a rational PCI alternative. In spite of the unquestionable benefits of DES in terms of reduction of restenosis and TVR, specific concerns have arisen with regard to their short-and long-term safety. We aim to assess short-and long-term outcomes in STEMI patients treated with Nobori, DES with biodegradable polymer. Methods: NOBORI 2 and eNOBORI are two large, prospective, single-arm, multicenter, registries that enrolled 3067 and 7750 patients respectively, out of which 248 and 703 were STEMI patients. All adverse events were adjudicated by an independent clinical event committee in NOBORI 2, while adjudication in eNOBORI (including stent thrombosis) is ongoing. The primary endpoint was Target Lesion Failure...