光学相干断层成像术评价依维莫司洗脱支架置入后 3 个月的新生内膜覆盖率：ENDEAVOR OCT 试验。
Evaluation in 3 months duration of neointimal coverage after zotarolimus-eluting stent implantation by optical coherence tomography: the ENDEAVOR OCT trial.
机构信息
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea.
出版信息
JACC Cardiovasc Interv. 2009 Dec;2(12):1240-7. doi: 10.1016/j.jcin.2009.10.006.
OBJECTIVES
We performed this study to investigate the vascular response in early period after zotarolimus-eluting stent (ZES) (Endeavor Sprint, Medtronic CardioVascular, Minneapolis, Minnesota) implantation.
BACKGROUND
The ZES has different characteristics, with biocompatible polymer and rapid drug-elution, compared with the first-generation drug-eluting stents (DES).
METHODS
The ENDEAVOR OCT (Evaluation in 3 Months Duration of Neointimal Coverage after Zotarolimus-Eluting Stent Implantation by Optical Coherence Tomography) trial is a prospective, single-center study evaluating vascular healing patterns with optical coherence tomography (OCT) at 3 months after stent implantation. A total of 31 ZES in 30 patients underwent serial OCT at immediate post-intervention and 3 months. Neointimal growth and malapposition were analyzed at each stent strut of cross-sectional OCT images with 0.5-mm intervals.
RESULTS
The incidence of malapposition at post-intervention and 3 months was 6.0% and 0.2%, respectively. However, late acquired malapposition was not detected at 3 months. Of 31 stents, 27 stents (87.1%) were covered completely with neointima, but the remaining 4 stents had 2 (0.8%), 4 (0.9%), 4 (1.2%), and 6 (1.4%) uncovered struts. Overall mean percentage of covered stent struts was 99.9 +/- 0.4%. This finding was consistent among groups with acute coronary syndrome and stable angina pectoris (99.9 +/- 0.3% vs. 99.9 +/- 0.4%, p = 0.92). Intracoronary thrombus was documented in 1 stent (3.2%) among 31 stents.
CONCLUSIONS
Most of the stent struts were covered with neointima, and late acquired malapposition was not found at 3 months after ZES implantation. Therefore, the current study demonstrated that ZES might have a favorable in vivo vascular response at 3 months after stent implantation. (Evaluation of Zotarolimus Eluting Stent at 3 Months Using Optical Coherence Tomography [ENDEAVOR OCT]; NCT00815139).
目的
我们进行这项研究旨在探究在新型西罗莫司洗脱支架（ Endeavor Sprint，美敦力心血管，明尼苏达州明尼阿波利斯）植入早期的血管反应。
背景
与第一代药物洗脱支架（DES）相比，新型 ZES 具有生物相容性聚合物和快速药物洗脱的特点。
方法
ENDEAVOR OCT（光学相干断层扫描评价西罗莫司洗脱支架植入后 3 个月内新生内膜覆盖情况）试验是一项前瞻性、单中心研究，通过光学相干断层扫描（OCT）在支架植入后 3 个月评估血管愈合模式。共有 30 例患者的 31 个 ZES 进行了即刻介入后和 3 个月的连续 OCT 检查。在每一个支架的横断面 OCT 图像上以 0.5mm 的间隔分析新生内膜的生长和贴壁不良情况。
结果
即刻介入和 3 个月时贴壁不良的发生率分别为 6.0%和 0.2%。然而，在 3 个月时并未发现迟发性贴壁不良。31 个支架中，27 个支架（87.1%）完全被新生内膜覆盖，但其余 4 个支架有 2（0.8%）、4（0.9%）、4（1.2%）和 6（1.4%）个未覆盖的支架。总的来说，覆盖的支架支架比例为 99.9%±0.4%。这一发现在急性冠脉综合征和稳定性心绞痛患者中是一致的（99.9%±0.3% vs. 99.9%±0.4%，p=0.92）。31 个支架中有 1 个（3.2%）支架发现了冠状动脉内血栓。
结论
大多数支架支架被新生内膜覆盖，在 ZES 植入后 3 个月时未发现迟发性贴壁不良。因此，本研究表明，ZES 在支架植入后 3 个月时可能具有良好的体内血管反应。（光学相干断层扫描评价西罗莫司洗脱支架 3 个月的疗效[ENDEAVOR OCT]；NCT00815139）。
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