Background:There is limited data comparing the Xience everolimus-eluting stent (EES) and the Resolute zotarolimus-eluting stent (ZES) with the BioMatrix biolimus-eluting stent (BES).Methods:This open-label, randomized, noninferiority trial enrolled all-comer patients to be randomly treated with either BES, EES, or ZES in a 1:1:1 ratio in 15 centers across South Korea. The primary end point was a device-oriented composite outcome consisting of cardiac death, target-vessel myocardial infarction, and clinically indicated target lesion revascularization at 24 months. The BES was compared with the EES and the ZES by intention-to-treat analyses with a noninferiority margin of 3.8%, respectively.Results:Because of slow recruitment and low event rates, this trial was prematurely terminated after enrollment of 1935 (75%) of the intended 2580 patients. Of the 1911 patients randomized to either EES (n=638), BES (n=634), or ZES (n =639), the rate of device-oriented composite outcome was 3.6%, 2.2%, and 3.9%, respectively, at 24 months (BES versus EES: absolute risk difference −1.4% [upper limit of 1-sided 95% CI: −3.2%]; P_{for noninferiority} <0.001; BES versus ZES: absolute risk difference −1.7% [upper limit of 1-sided 95% CI: −3.6%]; P_{for noninferiority} <0.001).Conclusions:The BES was noninferior to either the EES or the ZES in all-comer patients for device-oriented composite outcome at the 24-month follow-up. However, caution is advised regarding interpretation of these results due to the premature termination of this study.Registration:URL: https://www.clinicaltrials.gov; Unique identifier: NCT01397175.

中文翻译：

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全聚合物患者Everolimus和Zotarolimus洗脱冠状动脉支架与Biolimus洗脱支架的随机比较

背景：将Xience依维莫司洗脱支架（EES）和Resolute佐他莫司洗脱支架（ZES）与BioMatrix Biolimus洗脱支架（BES）进行比较的数据有限。方法：这项开放标签，随机，非劣效性试验纳入了所有受试者在韩国15个中心中按1：1：1的比例随机接受BES，EES或ZES治疗的新患者。主要终点是面向设备的复合结果，包括心脏死亡，靶血管心肌梗塞和临床指征的24个月靶病变血运重建。通过意向性治疗分析将BES与EES和ZES进行了比较，其非劣性边际分别为3.8％。结果：由于招募缓慢和事件发生率低，该试验在1935年招募后就提前终止（75％ ）的预期2580名患者。P_{为非劣效性}<0.001；BES与ZES：绝对风险差异为-1.7％[单面95％CI的上限：-3.6％]；P_{为非劣效性（} <0.001）。结论：在24个月的随访中，对于以器械为导向的复合结果，所有患者的BES均不劣于EES或ZES。但是，由于本研究过早终止，因此在解释这些结果时应谨慎行事。注册：URL：https://www.clinicaltrials.gov; 唯一标识符：NCT01397175。