Thoraxcenter, Erasmus Medical Center, Ba-583, s Gravendijkwal 230, 3015 CE Rotterdam, The Netherlands.
Eur Heart J. 2010 May;31(9):1071-8. doi: 10.1093/eurheartj/ehp599. Epub 2010 Jan 29.
To investigate the clinical impact of the following observations in the randomized SPIRIT II and III trials: an incremental increase in in-stent neointima between 1 and 2 years with the everolimus-eluting stent (EES) but not with the paclitaxel-eluting stent (PES) in SPIRIT II; a tendency of lower stent thrombosis in EES than in PES among those who first discontinued a thienopyridine after 6 months.
A pooled analysis was performed using the 2-year clinical data from the SPIRIT II and III trials randomizing a total of 1302 patients with de novo coronary artery lesions either to EES or to PES. Inclusion and exclusion criteria were comparable between two trials. Major adverse cardiac event (MACE) was defined as cardiac death, myocardial infarction, or ischaemia-driven target lesion revascularization (TLR). At 2 years, MACE rates were 7.1% in EES vs. 12.3% in PES, respectively (log-rank P = 0.0014), without late increase in TLR. Among those who first discontinued a thienopyridine after 6 months, Academic Research Consortium (ARC) definite or probable stent thrombosis was 1.1% in EES vs. 1.3% in PES (P = 1.00).
The benefits of EES in reducing TLR were robust between 6 months and 2 years. No significant difference in the thrombosis rate among those who first stopped a thienopyridine after 6 months was observed.
在 SPIRIT II 和 III 随机试验中观察到以下结果：在 SPIRIT II 中，依维莫司洗脱支架（EES）在 1 至 2 年内支架内新生内膜呈递增趋势，但紫杉醇洗脱支架（PES）则没有；在 6 个月后首次停用噻吩吡啶的患者中，EES 的支架血栓形成倾向低于 PES。
对 SPIRIT II 和 III 试验的 2 年临床数据进行了汇总分析，共纳入了 1302 例患有新发冠状动脉病变的患者，这些患者被随机分为 EES 组或 PES 组。两项试验的纳入和排除标准相似。主要不良心脏事件（MACE）定义为心脏死亡、心肌梗死或缺血驱动的靶病变血运重建（TLR）。2 年时，EES 组的 MACE 发生率为 7.1%，PES 组为 12.3%（log-rank P = 0.0014），TLR 无晚期增加。在 6 个月后首次停用噻吩吡啶的患者中，学术研究联合会（ARC）确定或可能的支架血栓形成在 EES 组为 1.1%，在 PES 组为 1.3%（P = 1.00）。
EES 在降低 TLR 方面的益处从 6 个月到 2 年都是稳健的。在 6 个月后首次停用噻吩吡啶的患者中，血栓形成率没有显著差异。
