PURPOSE:To assess the technical feasibility, thrombogenicity, and biocompatibility of a new biodegradable poly-L-lactic acid (PLLA) anastomotic stent. METHODS:A polytetrafluoroethylene bifurcated graft was implanted in 17 pigs through a midline abdominal incision. After transverse graft incision, 17 316L stainless steel stents and 17 PLLA stents were randomly implanted at both iliac anastomotic sites and deployed with a 6-mm balloon under direct vision without angiography. Intended follow-up was 1 week in 6 pigs receiving oral acetylsalicylic acid (ASA) and in 7 pigs receiving ASA/clopidogrel; 4 pigs receiving ASA/clopidogrel were followed for 6 weeks. At the end of the study, the segments containing the stents were surgically explanted and processed for histology to measure the mean luminal diameter, intimal thickness, and the vascular injury and inflammation scores. RESULTS:Initial technical success of stent placement was achieved in all animals without rupture of the suture. Two pigs died (unrelated to the stent) at 3 days after operation (1 in groups A and B). At 1 week, all PLLA stents showed thrombotic occlusion with the use of ASA alone. In contrast, all PLLA stents remained patent with concurrent administration of ASA/clopidogrel. All metal stents were patent regardless of the antiplatelet regimen. The mean luminal diameter of patent PLLA stents (4.13+/-0.17 mm) was comparable to metal stents (4.27+/-0.35 mm, p=0.78) at 1 week, but significantly diminished at 6 weeks (3.21+/-0.44 versus 4.19+/-0.18 mm, p=0.005). Histological analysis showed no signs of excessive recoil. PLLA stents induced a higher inflammation score (1.79+/-0.56) and more intimal hyperplasia (0.34+/-0.11 mm) compared to metal stents [1.27+/-0.44 mm (p<0.001) and 0.18+/-0.04 mm (p=0.006), respectively] at 6 weeks. Vascular injury was comparable between PLLA and metal stents. CONCLUSION:Biodegradable PLLA stents showed higher thrombogenicity and reduced patency compared to metal stents during early follow-up. Although ASA and clopidogrel prevented thrombotic occlusion, the increased inflammatory response and neointima formation remain major concerns of PLLA stents. A solution to this problem might be the incorporation of anti-inflammatory drugs into the PLLA stent.

译文

目的:评估新型可生物降解的聚-L-乳酸(PLLA)吻合支架的技术可行性,血栓形成性和生物相容性。
方法:通过腹部中线切口将聚四氟乙烯分叉移植物植入17头猪。横向移植后,将17个316L不锈钢支架和17个PLLA支架随机植入两个both吻合部位,并在不进行血管造影的情况下在直视下用6毫米球囊展开。预期的随访结果是:6头接受口服乙酰水杨酸(ASA)的猪和7头接受ASA /氯吡格雷的猪。对4只接受ASA /氯吡格雷的猪进行了6周的随访。在研究结束时,将包含支架的节段进行外科手术切除并进行组织学处理,以测量平均腔直径,内膜厚度以及血管损伤和炎症评分。
结果:在所有动物中均未发生缝线破裂的情况下,支架植入取得了初步的技术成功。手术后3天有2头猪死亡(与支架无关)(A和B组为1只)。在第1周,仅使用ASA时,所有PLLA支架均显示血栓闭塞。相反,所有PLLA支架在同时使用ASA /氯吡格雷的情况下仍保持专利。无论抗血小板方案如何,所有金属支架均已获得专利。专利PLLA支架的平均腔直径(4.13 /-0.17 mm)在1周时可与金属支架(4.27 /-0.35 mm,p = 0.78)相媲美,但在6周时显着减小(3.21 // 0.44对4.19 /-) 0.18毫米,p = 0.005)。组织学分析显示没有过度后坐的迹象。与金属支架[1.27 /-0.44 mm(p <0.001)和0.18 /-0.04 mm(p = 0.006)相比,PLLA支架引起更高的炎症评分(1.79 /-0.56)和更多的内膜增生(0.34 /-0.11 mm)。 ,分别在第6周。 PLLA和金属支架之间的血管损伤相当。
结论:在早期随访中,与金属支架相比,可生物降解的PLLA支架显示出更高的血栓形成性和通畅性降低。尽管ASA和氯吡格雷预防了血栓闭塞,但炎症反应和新内膜形成的增加仍然是PLLA支架的主要关注点。解决此问题的方法可能是将抗炎药掺入PLLA支架中。

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