Department of Cardiology, Academic Medical Center, University of Amsterdam, The Netherlands.
Circ Cardiovasc Interv. 2009 Aug;2(4):339-47. doi: 10.1161/CIRCINTERVENTIONS.108.831800.108.831800. Epub 2009 Jul 22.
This article reports the 2-year clinical, angiographic, and intravascular ultrasound outcomes of the everolimus-eluting stent (EES) compared with the paclitaxel-eluting stent (PES) in the randomized SPIRIT II trial.
This was a prospective, single-blind clinical trial in which a total of 300 patients with de novo native coronary artery lesions were randomized to either EES or PES in a 3:1 fashion. Clinical follow-up was planned at 2 years in all patients. A subset of 152 patients underwent serial angiographic and intravascular ultrasound analyses at 6 months and 2 years. After 2 years, target lesion failure (cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization) rates were 6.6% and 11% in EES and PES, respectively (P=0.31). At 6 months, a significant reduction in angiographic in-stent late loss and percentage volume obstruction measured by intravascular ultrasound was observed in the EES group. However, at 2-year follow-up, a late increased intimal hyperplasia growth after implantation of an EES was observed. There were no significant differences between EES and PES for in-stent late loss (EES, 0.33+/-0.37 mm versus PES, 0.34+/-0.34 mm; P=0.84) and percentage volume obstruction (EES, 5.18+/-6.22% versus PES, 5.80+/-6.31%; P=0.65) at 2 years. The incidence of stent thrombosis was low and comparable in both groups (EES, 0.9%; PES, 1.4%).
Although the previously reported angiographic and clinical superiority of the EES has vanished over time, this report confirms and extends the previously demonstrated noninferiority in terms of in-stent late loss of the EES when compared with the PES up to 2-year follow-up. There were no significant differences between EES and PES in clinical, angiographic and intravascular ultrasound outcomes at 2 years.
本文报道了依维莫司洗脱支架（EES）与紫杉醇洗脱支架（PES）在 SPIRIT II 随机临床试验中的 2 年临床、血管造影和血管内超声结果。
这是一项前瞻性、单盲临床试验，共 300 例初发的原发性冠状动脉病变患者以 3:1 的比例随机分为 EES 或 PES 组。所有患者均计划在 2 年时进行临床随访。其中 152 例患者在 6 个月和 2 年时进行了连续血管造影和血管内超声分析。2 年后，EES 和 PES 组的靶病变失败（心脏死亡、心肌梗死和缺血驱动的靶病变血运重建）发生率分别为 6.6%和 11%（P=0.31）。在 6 个月时，EES 组的血管造影支架内晚期丢失和血管内超声测量的百分比体积阻塞显著减少。然而，在 2 年随访时，观察到 EES 植入后内膜增生的晚期增长。EES 和 PES 组在支架内晚期丢失（EES，0.33+/-0.37 mm 对 PES，0.34+/-0.34 mm；P=0.84）和百分比体积阻塞（EES，5.18+/-6.22%对 PES，5.80+/-6.31%；P=0.65）方面无显著差异。两组支架血栓形成发生率均较低且相似（EES，0.9%；PES，1.4%）。
尽管 EES 的先前报道的血管造影和临床优势随着时间的推移已经消失，但本报告证实并扩展了之前的研究结果，即在 2 年随访时，EES 的支架内晚期丢失与 PES 相比无显著差异。EES 和 PES 组在 2 年时的临床、血管造影和血管内超声结果无显著差异。
