Division of Cardiology, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, South Korea (Y.J.Y., J.-W.L., S.G.A., S.-H.L., J.Y.).
Division of Cardiology, Inha University Hospital, Inha University College of Medicine, Incheon, South Korea (K.S.P.).
Circ Cardiovasc Interv. 2020 Mar;13(3):e008525. doi: 10.1161/CIRCINTERVENTIONS.119.008525. Epub 2020 Mar 12.
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).
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.
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%]; <0.001; BES versus ZES: absolute risk difference -1.7% [upper limit of 1-sided 95% CI: -3.6%]; <0.001).
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.
比较 Xience 依维莫司洗脱支架（EES）和 Resolute 佐他莫司洗脱支架（ZES）与 BioMatrix 依维莫司洗脱支架（BES）的相关数据有限。
这项开放标签、随机、非劣效性试验纳入了韩国 15 个中心的所有患者，以 1:1:1 的比例随机接受 BES、EES 或 ZES 治疗。主要终点是 24 个月时的以器械为导向的复合终点，包括心源性死亡、靶血管心肌梗死和临床指征靶病变血运重建。BES 与 EES 和 ZES 的比较均采用意向治疗分析，非劣效性边界分别为 3.8%。
由于招募缓慢和低事件发生率，该试验在计划入组的 2580 例患者中的 1935 例（75%）入组后提前终止。在随机接受 EES（n=638）、BES（n=634）或 ZES（n=639）的 1911 例患者中，24 个月时以器械为导向的复合终点发生率分别为 3.6%、2.2%和 3.9%（BES 与 EES：绝对风险差异-1.4%[单侧 95%CI 的上限：-3.2%]；<0.001；BES 与 ZES：绝对风险差异-1.7%[单侧 95%CI 的上限：-3.6%]；<0.001）。
在所有患者中，BES 在 24 个月随访时的以器械为导向的复合终点方面不劣于 EES 或 ZES。然而，由于该研究的提前终止，对这些结果的解释应谨慎。注册：网址：https://www.clinicaltrials.gov；唯一标识符：NCT01397175。
