Division of Cardiology, Department of Internal Medicine, Kangwon National University School of Medicine; Chuncheon-South Korea.
Cardiovascular Center, Korea University Guro Hospital; Seoul-South Korea.
Anatol J Cardiol. 2020 Apr;23(5):268-276. doi: 10.14744/AnatolJCardiol.2020.80845.
There is a scarcity of comparative studies between Endeavor Resolute®-zotarolimus-eluting stent (R-ZES) and Resolute Integrity®-ZES (I-ZES) during long-term follow-up periods. Although the stent alloy and the polymer of these two ZESs are similar, the platform and the design of these two stents are different. This study was conducted to compare the efficacy and safety of these two different ZESs in the all-comer Korean patients who underwent percutaneous coronary intervention (PCI) during a 3-year follow-up period.
This study was performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki. In this single-center, retrospective, and all-comer patients' cohort study, a total of 889 patients who underwent PCI with R-ZES (n=394) or I-ZES (n=495) were enrolled. The primary endpoint was the occurrence of major adverse cardiac events (MACEs) defined as all-cause death, nonfatal myocardial infarction (MI), any repeat revascularization including target lesion revascularization (TLR), target vessel revascularization (TVR), and non-TVR, and the secondary endpoint was stent thrombosis (ST) at 3 years.
To adjust for any potential confounders, the propensity score-adjusted multivariable analysis was performed using the logistic regression model (C-statistics=0.689). The cumulative incidence rates of MACEs [adjusted hazard ratio (aHR), 1.341; 95% confidence interval (CI), 0.615-2.922; p=0.461], all-cause death, nonfatal MI, any repeat revascularization, and ST (aHR, 2.090; 95% CI, 0.163-26.77; p=0.571) were similar between the two groups during the 3-year follow-up period.
R-ZES and I-ZES demonstrated comparable efficacy and safety after PCI during a 3-year follow-up period. However, these results can perhaps be more precisely defined by other large and long-term follow-up studies in the future. (Anatol J Cardiol 2020; 23: 268-76).
在长期随访期间， Endeavor Resolute®-佐他莫司洗脱支架（R-ZES）和 Resolute Integrity®-ZES（I-ZES）之间缺乏比较研究。尽管这两种 ZES 的支架合金和聚合物相似，但这两种支架的平台和设计不同。本研究旨在比较这两种不同的 ZES 在接受经皮冠状动脉介入治疗（PCI）的全患者韩国患者中的疗效和安全性在 3 年的随访期间。
本研究符合 1964 年《赫尔辛基宣言》规定的伦理标准。在这项单中心、回顾性和全患者队列研究中，共纳入 889 例接受 R-ZES（n=394）或 I-ZES（n=495）PCI 的患者。主要终点是主要不良心脏事件（MACE）的发生，定义为全因死亡、非致死性心肌梗死（MI）、任何重复血运重建，包括靶病变血运重建（TLR）、靶血管血运重建（TVR）和非 TVR，次要终点是 3 年内支架血栓形成（ST）。
为了调整任何潜在的混杂因素，使用逻辑回归模型进行了倾向评分调整的多变量分析（C 统计量=0.689）。MACE 的累积发生率[调整后的危险比（aHR），1.341；95%置信区间（CI），0.615-2.922；p=0.461]、全因死亡、非致死性 MI、任何重复血运重建和 ST（aHR，2.090；95%CI，0.163-26.77；p=0.571）在 3 年随访期间，两组之间相似。
在 3 年随访期间，R-ZES 和 I-ZES 经 PCI 后显示出相似的疗效和安全性。然而，这些结果或许可以通过未来其他大型和长期随访研究更精确地定义。
