Shen Li, Wu Yizhe, Ge Lei, Zhang Yaojun, Wang Qibing, Qian Juying, Qiu Zhifen, Ge Junbo
Department of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, 180 Fenglin Road, Shanghai, 200032, China.
Department of Cardiology, Xuzhou Third People's Hospital, Xuzhou Medical University, Xuzhou, China.
Int J Cardiovasc Imaging. 2017 Oct;33(10):1473-1481. doi: 10.1007/s10554-017-1148-5. Epub 2017 Jun 21.
We aimed to investigate the safety and efficacy of XINSORB bioresorbable sirolimus-eluting scaffold in porcine model. XINSORB scaffolds and metallic Firebird2™ stents were randomly implanted into minipigs' coronary arteries. Angiography, optical coherent tomography (OCT) and histopathological analyses were performed at post-procedure and 14-, 28-, 90-, 180-day follow-up. Thirty-two minipigs were enrolled. Eight XINSORB scaffolds and 8 Firebird2 stents were examined at each time point. Quantitative coronary angiography showed that in-scaffold late luminal loss (LLL) of XINSORB scaffold was 0.26 ± 0.13, 0.50 ± 0.16, 0.88 ± 0.29 and 0.43 ± 0.24 mm at 14-, 28, 90-, and 180-day follow-up respectively, and the corresponding diameter stenosis (DS) was 7.3 ± 4.7, 12.0 ± 9.5, 22.1 ± 8.0, and 16.0 ± 9.5%. Neither in-scaffold LLL nor DS of XINSORB scaffold was significantly different in comparison with Firebird2 stent. No difference of luminal area, device area, neointimal hyperplasia, and area stenosis was detected between two devices under OCT. Scaffold area of XINSORB remained steady through the observation. Histopathology revealed the similar findings. The greatest late recoil of XINSORB scaffold was about 4.12% at 90-day follow-up, which was comparable to Firebird2 stent. Both devices showed low injury or inflammation of vessel wall. XINSORB scaffold showed early neointimal coverage on struts within 28 days under scanning electron microscopy. XINSORB scaffold suppressed neointimal hyperplasia as effectively as Firebird2 did without obvious late device recoil during the 180 days follow-up. It is feasible to carry out clinical trial to investigate the safety and efficacy of XINSORB scaffold for patients with coronary artery diseases.
我们旨在研究XINSORB生物可吸收西罗莫司洗脱支架在猪模型中的安全性和有效性。将XINSORB支架和金属Firebird2™支架随机植入小型猪的冠状动脉。在术后以及14天、28天、90天、180天随访时进行血管造影、光学相干断层扫描（OCT）和组织病理学分析。共纳入32只小型猪。每个时间点检查8个XINSORB支架和8个Firebird2支架。定量冠状动脉造影显示，XINSORB支架在14天、28天、90天和180天随访时的支架内晚期管腔丢失（LLL）分别为0.26±0.13、0.50±0.16、0.88±0.29和0.43±0.24mm，相应的直径狭窄（DS）分别为7.3±4.7%、12.0±9.5%、22.1±8.0%和16.0±9.5%。与Firebird2支架相比，XINSORB支架的支架内LLL和DS均无显著差异。在OCT下，两种器械之间未检测到管腔面积、器械面积、新生内膜增生和面积狭窄的差异。XINSORB的支架面积在观察期间保持稳定。组织病理学显示出相似的结果。XINSORB支架在90天随访时最大晚期回缩约为4.12%，与Firebird2支架相当。两种器械均显示血管壁损伤或炎症较轻。扫描电子显微镜下，XINSORB支架在28天内即可在支柱上出现早期新生内膜覆盖。在180天随访期间，XINSORB支架抑制新生内膜增生的效果与Firebird2支架相当，且无明显的晚期器械回缩。对冠状动脉疾病患者开展XINSORB支架安全性和有效性的临床试验是可行的。
