生物可吸收聚合物涂层雷帕霉素洗脱支架置入后 6、12 和 24 个月的连续光学相干断层扫描评估
Serial Optical Coherence Tomography Evaluation at 6, 12, and 24 Months After Biolimus A9-Eluting Biodegradable Polymer-Coated Stent Implantation.
机构信息
Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Hyogo, Japan.
Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Hyogo, Japan.
出版信息
Can J Cardiol. 2015 Aug;31(8):980-8. doi: 10.1016/j.cjca.2015.02.036. Epub 2015 Mar 5.
BACKGROUND
The Nobori (Terumo Corporation, Tokyo, Japan) is a biolimus A9-eluting stent (BES) featured with a biodegradable polymer coated on the abluminal side only. We previously reported that favourable vessel healing was achieved at 6-12 months after BES implantation. However, detailed long-term vessel reaction after BES deployment is unclear.
METHODS
Twenty-two BESs were serially evaluated using optical coherence tomography (OCT) at 6, 12, and 24 months after stenting. Average neointimal thickness, uncovered struts, and neointimal unevenness score (each cross-section as maximum neointimal thickness in 1 cross section divided by the average neointimal thickness of the same cross-section) were manually measured. In addition, we evaluated the percentage of struts with peri-strut low-intensity area (a region around stent struts that homogenously showed less intensity than the surrounding tissue, which suggests fibrin deposition or impaired neointima maturation), thrombi, and atherogenic neointimas (neointimas containing a diffuse border and poor-signal region with invisible struts due to marked signal attenuation).
RESULTS
Serial OCT observation revealed a small gradual increase in neointimal thickness from 6 to 24 months (73 ± 24 μm; 81 ± 26 μm; and 108 ± 35 μm, respectively, P = 0.001) with a nonsignificant decrease in the lumen area (6.36 ± 1.98 mm(2); 6.18 ± 2.04 mm(2); and 5.87 ± 2.06 mm(2); P = 0.72). Frequency of uncovered struts (3.89 ± 3.91%; 1.55 ± 1.63%; and 0.23 ± 0.67%; P = 0.001), neointimal unevenness score (1.95 ± 0.18% to 1.86 ± 0.19% to 1.78 ± 0.17; P = 0.012), percentage of thrombi (5%, 0%, and 0%; P = 0.37) and peri-strut low-intensity area (6.8%, 5.1%, and 1.6%; P = 0.017) decreased from 6 to 12 and 24 months. Atherogenic neointima was not observed in the event-free OCT cohort.
CONCLUSIONS
The Nobori stent achieved acceptable long-term vessel healing, mostly without adverse vessel reactions.
背景
Nobori（Terumo 公司，东京，日本）是一种载有生物可降解聚合物的雷帕霉素洗脱支架（BES），仅在血管腔面涂有聚合物。我们之前报道过，BES 植入后 6-12 个月血管愈合良好。然而，BES 植入后详细的长期血管反应尚不清楚。
方法
22 个 Nobori 支架在支架植入后 6、12 和 24 个月时使用光学相干断层扫描（OCT）进行连续评估。手动测量平均新生内膜厚度、无覆盖支架和新生内膜不均匀评分（每个截面的最大新生内膜厚度除以同一截面的平均新生内膜厚度）。此外，我们评估了支架周围低强度区域（支架周围区域的强度均匀低于周围组织，提示纤维蛋白沉积或新生内膜成熟受损）、血栓和动脉粥样硬化性新生内膜（包含弥漫边界和由于信号衰减导致不可见支架的不良信号区域的新生内膜）的支架数量百分比。
结果
连续 OCT 观察显示，从 6 个月到 24 个月，新生内膜厚度逐渐缓慢增加（73 ± 24 μm；81 ± 26 μm；和 108 ± 35 μm，P = 0.001），管腔面积无明显减少（6.36 ± 1.98 mm²；6.18 ± 2.04 mm²；和 5.87 ± 2.06 mm²；P = 0.72）。无覆盖支架的频率（3.89 ± 3.91%；1.55 ± 1.63%；和 0.23 ± 0.67%；P = 0.001）、新生内膜不均匀评分（1.95 ± 0.18%至 1.86 ± 0.19%至 1.78 ± 0.17%；P = 0.012）、血栓百分比（5%、0%和 0%；P = 0.37）和支架周围低强度区域（6.8%、5.1%和 1.6%；P = 0.017）从 6 个月到 12 个月和 24 个月逐渐减少。在无事件 OCT 队列中未观察到动脉粥样硬化性新生内膜。
结论
Nobori 支架实现了可接受的长期血管愈合，且无明显不良血管反应。
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