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XIENCE V依维莫司药物洗脱支架与TAXUS药物洗脱支架的5年结果对比:来自SPIRIT III随机试验的最终结果

Five-Year Results of a Randomized Comparison of XIENCE V Everolimus-Eluting and TAXUS Paclitaxel-Eluting Stents: Final Results From the SPIRIT III Trial

来源:爱思唯尔 发布时间:2013-12-31
期刊: JACC: Cardiovascular Interventions2013年11月期卷

Objectives

We 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 vs PES. Endpoints included ischemia-driven target vessel failure (TVF: death, myocardial infarction, (MI) or ischemia-driven target vessel revascularization [TVR]), the prespecified 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 vs. 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 non-significantly 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.

 

主要结论:与TAXUS药物洗脱支架相比,XIENCE V依维莫司药物洗脱支架在安全性和疗效的复合指标以及全因死亡率方面均有持续获益。

 

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