SPIRIT III 试验的 5 年随机对照研究结果：依维莫司洗脱 XIENCE V 支架与紫杉醇洗脱 Taxus 支架的比较——治疗初发的 native 冠状动脉病变患者的 XIENCE V 依维莫司洗脱冠状动脉支架系统的临床评估。
5-year results of a randomized comparison of XIENCE V everolimus-eluting and TAXUS paclitaxel-eluting stents: final results from the SPIRIT III trial (clinical evaluation of the XIENCE V everolimus eluting coronary stent system in the treatment of patients with de novo native coronary artery lesions).
机构信息
Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York.
Wake Medical Center, Raleigh, North Carolina.
出版信息
JACC Cardiovasc Interv. 2013 Dec;6(12):1263-6. doi: 10.1016/j.jcin.2013.07.009. Epub 2013 Nov 13.
OBJECTIVES
This study sought to evaluate the long-term safety and efficacy of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in patients with obstructive coronary artery disease.
BACKGROUND
The use of EES compared to PES has been shown to result in improved clinical outcomes in patients undergoing PCI. However, there have been concerns regarding the durability of these benefits over longer-term follow-up.
METHODS
SPIRIT III was a prospective, multicenter trial in which 1,002 patients were randomized 2:1 to EES versus PES. Endpoints included ischemia-driven target vessel failure (TVF) (death, myocardial infarction (MI), or ischemia-driven target vessel revascularization [TVR]), the pre-specified primary endpoint), target lesion failure (TLF) (cardiac death, target-vessel MI, or ischemia-driven target lesion revascularization [TLR]), major adverse cardiac events (MACE) (cardiac death, MI, or ischemia-driven TLR), their individual components and stent thrombosis.
RESULTS
Five-year follow-up was available in 91.9% of patients. Treatment with EES versus PES resulted in lower 5-year Kaplan-Meier rates of TVF (19.3% vs. 24.5%, p = 0.05), TLF (12.7% vs. 19.0%, p = 0.008), and MACE (13.2% vs. 20.7%, p = 0.007). EES also resulted in reduced rates of all-cause death (5.9% vs. 10.1%, p = 0.02), with nonsignificantly different rates of MI, stent thrombosis, and TLR, and no evidence of late catch-up of TLR over time.
CONCLUSIONS
At 5 years after treatment, EES compared to PES resulted in durable benefits in composite safety and efficacy measures as well as all-cause mortality. Additionally, the absolute difference in TLR between devices remained stable over time without deterioration of effect during late follow-up.
目的
本研究旨在评估在患有阻塞性冠状动脉疾病的患者中，依维莫司洗脱支架（EES）和紫杉醇洗脱支架（PES）的长期安全性和疗效。
背景
与 PES 相比，EES 的使用已被证明可改善接受 PCI 的患者的临床结局。然而，人们一直担心这些益处在长期随访中是否具有持久性。
方法
SPIRIT III 是一项前瞻性、多中心试验，共纳入 1002 例患者，以 2:1 的比例随机分配至 EES 组或 PES 组。终点包括缺血驱动的靶血管失败（TVF）（死亡、心肌梗死（MI）或缺血驱动的靶血管血运重建[TVR]）（主要终点）、靶病变失败（TLF）（心源性死亡、靶血管 MI 或缺血驱动的靶病变血运重建[TLR]）、主要不良心脏事件（MACE）（心源性死亡、MI 或缺血驱动的 TLR）、其各自的组成部分和支架血栓形成。
结果
91.9%的患者获得了 5 年随访。与 PES 相比，EES 治疗的 5 年 Kaplan-Meier 率的 TVF（19.3%比 24.5%，p=0.05）、TLF（12.7%比 19.0%，p=0.008）和 MACE（13.2%比 20.7%，p=0.007）较低。EES 还降低了全因死亡率（5.9%比 10.1%，p=0.02），MI、支架血栓形成和 TLR 的发生率无显著差异，且 TLR 随时间的推移无晚期追赶现象。
结论
治疗后 5 年，与 PES 相比，EES 在复合安全性和疗效指标以及全因死亡率方面具有持久的益处。此外，两种器械之间 TLR 的绝对差异在整个研究期间保持稳定，且晚期随访中无疗效恶化。
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