St. Vincent Heart Center of Indiana, Indianapolis, Indiana, USA.
J Interv Cardiol. 2012 Dec;25(6):565-75. doi: 10.1111/j.1540-8183.2012.00766.x. Epub 2012 Sep 23.
This 2-year follow-up of the XIENCE V USA study examines both the long-term safety and effectiveness of the everolimus-eluting coronary stent system (EECSS) in real-world patients.
The safety and effectiveness of EECSS at 1 year in real-world clinical settings have been demonstrated in XIENCE V USA trial with low rates of target lesion revascularization (TLR), cardiac death, myocardial infarction (MI), and stent thrombosis (ST). Data on whether efficacy is maintained after 1 year and the event rate of very late stent thrombosis (VLST) between 1 and 2 years have not yet been reported.
XIENCE V USA is a prospective, multicenter, single-arm, FDA required condition of approval study designed to examine the safety and effectiveness of EECSS in an all-inclusive, consecutively enrolled population from real-world clinical settings. Clinical end-point events, including ST, cardiac death, MI, and revascularization were adjudicated by an independent Clinical Events Committee.
Four thousand eight hundred and seventy-three (96.4%) out of 5,054 participants (1,875 standard-risk; 3,059 extended-risk) reached 2-year follow-up. The 2-year rate of Academic Research Consortium (ARC)-defined definite and probable ST was 0.96% (95% CI 0.70-1.28) in the overall population and 0.34% (95% CI 0.12-0.74) and 1.33% (95% CI 0.95-1.81) in the standard-risk and extended-risk cohorts, respectively. The rate of VLST was 0.06% in the overall population, 0.0% in the standard-risk, and 0.10% in the extended-risk cohorts. The 2-year composite rate of cardiac death and ARC-defined MI was 8.9% (95% CI 8.08-9.70) in the overall population and 5.6% (95% CI 4.61-6.78) and 10.8% (95% CI 9.71-11.94) in the standard-risk and extended-risk cohorts, respectively.
Low event rates observed at 1 year were maintained through 2 years. Despite the increased number of patients who discontinued dual antiplatelet therapy by 2 years, the ST rate remained consistently low, and <1% at 2 years due to low VLST occurrence. These results demonstrate continued safety and effectiveness of the XIENCE V everolimus-eluting stent in a highly complex, real-world patient population through 2 years.
本项对 XIENCE V USA 研究的 2 年随访旨在评估依维莫司洗脱冠状动脉支架系统（EECSS）在真实世界患者中的长期安全性和有效性。
XIENCE V USA 试验中，EECSS 在 1 年时的安全性和有效性已得到证实，其靶病变血运重建（TLR）、心源性死亡、心肌梗死（MI）和支架血栓形成（ST）发生率较低。但目前尚未报道 1 年后的疗效是否仍能维持，以及 1 至 2 年内非常晚期支架血栓形成（VLST）的发生率。
XIENCE V USA 是一项前瞻性、多中心、单臂、FDA 要求的批准后研究，旨在评估 EECSS 在真实世界临床环境中涵盖所有患者的安全性和有效性。临床终点事件（包括 ST、心源性死亡、MI 和血运重建）由独立的临床事件委员会裁定。
在 5054 例参与者中，4873 例（1875 例标准风险；3059 例扩展风险）达到 2 年随访。总体人群中，学术研究联合会（ARC）定义的明确和可能 ST 的 2 年发生率为 0.96%（95%CI 0.70-1.28），标准风险和扩展风险队列的发生率分别为 0.34%（95%CI 0.12-0.74）和 1.33%（95%CI 0.95-1.81）。总体人群、标准风险人群和扩展风险人群的 VLST 发生率分别为 0.06%、0.0%和 0.10%。总体人群的 2 年复合心脏死亡和 ARC 定义的 MI 发生率为 8.9%（95%CI 8.08-9.70），标准风险和扩展风险队列的发生率分别为 5.6%（95%CI 4.61-6.78）和 10.8%（95%CI 9.71-11.94）。
1 年时观察到的低事件率在 2 年内得以维持。尽管到 2 年时停用双联抗血小板治疗的患者数量增加，但 ST 率仍保持较低水平，2 年时 <1%，这主要归因于 VLST 发生率较低。这些结果表明，在 2 年时，依维莫司洗脱 XIENCE V 支架在高度复杂的真实世界患者人群中仍保持安全性和有效性。
