Taavitsainen Jouni, Tarvainen Santeri, Kuivanen Antti, Mangiardi Eric K, Guelcher Manfred, Martin John, Mathur Anthony, Hytönen Jarkko P, Ylä-Herttuala Seppo
A.I. Virtanen Institute for Molecular Sciences, Department of Molecular Medicine, University of Eastern Finland, Kuopio, Finland.
Q3 Medical Devices Ltd., Dublin, Ireland.
J Vasc Res. 2020;57(2):65-75. doi: 10.1159/000505454. Epub 2020 Feb 7.
Percutaneous coronary intervention is routinely performed to treat occlusive coronary artery disease. Coronary perforation is a potential complication and can be treated with a stent graft. Current stent grafts are associated with high restenosis rates. We tested the safety and feasibility of biodegradable stent grafts in pig and rabbit models.
Stent grafts were examined in pig coronaries with repeated OCT imaging for 42 days. Novel biodegradable coatings were applied on a bare metal stent by either an electrospinning (ES) or dip coating (DC) method. A completely biodegradable system was made by ES coating a magnesium-based stent. A commercially available stent graft served as a control. ES devices showed less restenosis (44.3 ± 8.8 vs. 59.1 ± 11.1% in controls, p < 0.05) and smaller reduction in minimum lumen area (44.3 ± 13.4 vs. 64.4 ± 13.6% in controls, p < 0.05) at day 42. DC devices occluded during follow-up. ES devices showed recanalization through the graft wall at day 42. Feasibility of the ES and DC devices was evaluated in pig coronary aneurysms and rabbit aortic perforation models and sealed aneurysms and perforations without complications.
Recanalization of the graft wall improves biocompatibility. Biodegradable stent grafts may present an alternative to permanent implants by showing reduced restenosis at day 42.
经皮冠状动脉介入治疗常用于治疗闭塞性冠状动脉疾病。冠状动脉穿孔是一种潜在并发症，可采用覆膜支架进行治疗。目前的覆膜支架与高再狭窄率相关。我们在猪和兔模型中测试了可生物降解覆膜支架的安全性和可行性。
在猪冠状动脉中使用重复光学相干断层扫描成像对覆膜支架进行42天的观察。通过静电纺丝（ES）或浸涂（DC）方法在裸金属支架上涂覆新型可生物降解涂层。通过ES法在镁基支架上涂覆制成完全可生物降解的系统。使用市售覆膜支架作为对照。在第42天时，ES装置显示出较低的再狭窄率（44.3±8.8%，对照组为59.1±11.1%，p<0.05）和较小的最小管腔面积减小（44.3±13.4%，对照组为64.4±13.6%，p<0.05）。DC装置在随访期间发生闭塞。ES装置在第42天时显示通过移植物壁再通。在猪冠状动脉瘤和兔主动脉穿孔模型中评估了ES和DC装置的可行性，其封闭了动脉瘤和穿孔且无并发症。
移植物壁的再通改善了生物相容性。可生物降解覆膜支架在第42天时显示出较低的再狭窄率，可能是永久性植入物的一种替代选择。
