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. (Comparison of the Efficacy and the Safety of Zotarolimus-Eluting Stent Versus Sirolimus-Eluting Stent and PacliTaxel-Eluting Stent for Coronary Lesions; NCT00418067)
Bibliographical noteFunding Information:
Dr. S. J. Park reports receiving consulting fees from Cordis, lecture fees from Cordis, Medtronic, and Boston Scientific, and research grant support from Cordis and Medtronic . Dr. Y. H. Kim reports receiving lecture fees from Cordis. Dr. C. W. Lee reports receiving lectures fees from Medtronic. Dr. S. W. Park reports receiving research grant support from Medtronic . Dr. Seong reports receiving research grant support from Boston Scientific . Drs. Jeong and Yoon report receiving lecture fees from Cordis, Medtronic, and Boston Scientific. Drs. Yang and Lim report receiving lecture fees from Cordis and Medtronic. Dr. Chae reports receiving research grant support from Cordis . Dr. Choi reports receiving lecture fees from Cordis, Abbott Vascular, Medtronic, and Boston Scientific. Drs. Tahk and K. S. Kim report receiving lecture fees from Boston Scientific. Dr. H. S. Kim reports receiving consulting fees from Abbott Vascular. Drs. N. H. Lee, Cheong, Seung, Hur, Hong, and H. S. Park report receiving lecture fees from Cordis and Boston Scientific.
This study was supported by funds from the CardioVascular Research Foundation , Seoul, Korea, and Medtronic Vascular , Santa Rosa, California.
All Science Journal Classification (ASJC) codes
- Cardiology and Cardiovascular Medicine