Park DW， Kim YH， Yun SC， Kang SJ， Lee SW， Lee CW， Park SW， Seong IW， Lee JH， Tahk SJ， Jeong MH， Jang Y， Cheong SS， Yang JY， Lim DS， Seung KB， Chae JK， Hur SH， Lee SG， Yoon J， Lee NH， Choi YJ， Kim HS， Kim KS， Kim HS， Hong TJ， Park HS， Park SJ.
Department of Cardiology， Center for Medical Research and Information， University of Ulsan College of Medicine， Asan Medical Center， Seoul， Korea.
Abstract
OBJECTIVES: The aim of this study was to evaluate the relative efficacy and safety of zotarolimus-eluting stents (ZES) in comparison with the established and widely used sirolimus- (SES) and paclitaxel-eluting stents (PES) in routine clinical practice.
BACKGROUND: Whether ZES might provide similar clinical and angiographic outcomes in a broad spectrum of patients compared with SES or PES is undetermined.
METHODS: We performed a single-blind， multicenter， prospectively randomized trial to compare ZES with SES and PES in 2，645 patients undergoing percutaneous coronary intervention. The primary end point was a composite of major adverse cardiac events (MACE) (death， myocardial infarction， and ischemia-driven target vessel revascularization) at 12 months. A noninferiority comparison (ZES vs. SES) and a superiority comparison (ZES vs. PES) were performed for the primary end point.
RESULTS: Baseline clinical and angiographic characteristics were similar in the 3 groups. At 12 months， the ZES group showed noninferior rates of MACE compared with the SES group (10.2% vs. 8.3%， p for noninferiority = 0.01， p for superiority = 0.17) and significantly fewer MACE than the PES group (10.2% vs. 14.1%， p for superiority = 0.01). The incidence of death or myocardial infarction was similar among the groups (ZES vs. SES vs. PES， 5.8% vs. 6.9% vs. 7.6%， respectively， p = 0.31). The incidence of stent thrombosis was significantly lower in the SES group (ZES vs. SES vs. PES， 0.7% vs. 0% vs. 0.8%， respectively， p = 0.02).
CONCLUSIONS: In this large-scale， practical randomized trial， the use of ZES resulted in similar rates of MACE compared with SES and in fewer MACE compared with PES at 12 months.