Wake Forest University Health Sciences, Winston-Salem, NC, USA.
Am J Cardiol. 2011 Mar 15;107(6):833-40. doi: 10.1016/j.amjcard.2010.10.069. Epub 2011 Jan 19.
The safety and efficacy of the XIENCE V everolimus-eluting stent (EES) compared to the Taxus Express(2) paclitaxel-eluting stent (PES) has been demonstrated through 2 years in the SPIRIT II and III randomized clinical trials, but limited longer-term data have been reported. In the SPIRIT III trial, 1,002 patients with up to 2 lesions in 2 coronary arteries were randomized 2:1 to EESs versus PESs at 65 United States sites. At completion of 3-year follow-up, treatment with EES compared to PES resulted in a significant 30% decrease in the primary clinical end point of target vessel failure (cardiac death, myocardial infarction, or ischemic-driven target vessel revascularization, 13.5% vs 19.2%, hazard ratio 0.70, 95% confidence interval 0.50 to 0.96, p = 0.03) and a 43% decrease in major adverse cardiovascular events, cardiac death, myocardial infarction, or ischemic-driven target lesion revascularization (9.1% vs 15.7%, hazard ratio 0.57, 95% confidence interval 0.39 to 0.83, p = 0.003). In a landmark analysis, major adverse cardiovascular events were decreased to a similar extent with EES compared to PES 0 through 1 year and 1 year through 3 years (hazard ratio 0.56, 95% confidence interval 0.35 to 0.90; hazard ratio 0.59, 95% confidence interval 0.31 to 1.11, respectively). In conclusion, patients treated with EES rather than PES in the SPIRIT III trial had significantly improved event-free survival at 3 years. From 1 year to 3 years hazard curves continued to diverge in favor of EES, consistent with an improving long-term safety and efficacy profile of EES compared to PES, with no evidence of late catchup.
在 SPIRIT II 和 III 随机临床试验中，与紫杉醇洗脱支架（PES）相比，XIENCE V 依维莫司洗脱支架（EES）的安全性和疗效已在 2 年内得到证实，但报告的长期数据有限。在 SPIRIT III 试验中，1002 例患者在 2 条冠状动脉中最多有 2 个病变，在 65 个美国地点以 2:1 的比例随机分配至 EES 组或 PES 组。在 3 年随访结束时，与 PES 相比，EES 治疗可使主要临床终点（靶血管失败）显著降低 30%（心脏死亡、心肌梗死或缺血驱动的靶血管血运重建，13.5% vs. 19.2%，风险比 0.70，95%置信区间 0.50 至 0.96，p=0.03），主要不良心血管事件（心脏死亡、心肌梗死或缺血驱动的靶病变血运重建）降低 43%（9.1% vs. 15.7%，风险比 0.57，95%置信区间 0.39 至 0.83，p=0.003）。在里程碑式分析中，EES 与 PES 相比，0 至 1 年和 1 年至 3 年的主要不良心血管事件发生率降低程度相似（风险比 0.56，95%置信区间 0.35 至 0.90；风险比 0.59，95%置信区间 0.31 至 1.11）。总之，在 SPIRIT III 试验中接受 EES 治疗的患者在 3 年内的无事件生存率显著提高。从 1 年到 3 年，风险曲线继续向有利于 EES 的方向发散，与 EES 相比 PES 的长期安全性和疗效持续改善一致，没有后期追赶的迹象。
