Sperling Christian, Waliszewski Matthias W, Kherad Behrouz, Krackhardt Florian
Medical Scientific Affairs, B. Braun Melsungen AG, Berlin, Germany.
Department of Internal Medicine and Cardiology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Ther Adv Cardiovasc Dis. 2019 Jan-Dec;13:1753944719826335. doi: 10.1177/1753944719826335.
: Polymer-free drug-eluting stents (DES) without permanent-polymer coating may be associated with rapid vessel healing, providing a rationale to reduce dual-antiplatelet therapy (DAPT). The aim of the current study was to compare vessel healing of a polymer-free sirolimus-eluting stent (PF-SES), its bare metal stent (BMS) analogue to a permanent polymer-based sirolimus-eluting stent (SES) with proven effectiveness in porcine coronary arteries.
: An ultrathin-strut cobalt-chromium PF-SES, its BMS analogue and an SES with a permanent polymer were used to study vessel healing and their antistenotic potential. Stents were implanted in porcine coronary arteries for histopathologic analysis at 7, 28 and 180 days. In an additional in vitro study, the thrombogenicity of PF-SES was compared with a fluoropolymer-coated everolimus-eluting stent (EES) which demonstrated low stent thrombosis rates in numerous studies.
: In the animal study, neointimal growth and injury scores were minimal and inflammation scores were low in the neointima and adventitia in all study groups. After 28 days, neointimal area was lowest in PF-SES when compared with SES and BMS (1.48 ± 0.55 mm² versus 2.43 ± 0.69 mm² versus 1.90 ± 0.85 mm², respectively, p < 0.05) and endothelialization of luminal surfaces was nearly complete in all groups, though SES show the least coverage with occasional adherent luminal inflammatory cells ( p > 0.05). At 180 days, neointimal area and thickness were most pronounced in SES ( p < 0.05) and comparable with BMS implantations, which were characterized by nearly completed vessel healing. PF-SES and BMS had complete endothelialization, absence of fibrin and sustained low inflammatory reaction when compared with the permanent polymer-based SES (inflammation score: PF-SES 0.41 ± 0.74 versus SES 2.52 ± 1.72 versus BMS 0.30 ± 0.65, respectively, p < 0.05 BMS versus SES). Granuloma formation and fibrin accumulation were most pronounced in SES but did not reach statistical significance, p > 0.05). In the in vitro thrombogenicity study, the PF-SES confirmed comparable antithrombogenic properties with regard to the parameters fibrin and platelet binding, and platelet aggregation when compared with the EES.
: As compared with BMS, the ultrathin-strut cobalt-chromium PF-SES showed similar endothelialization at 28 days and comparable healing characteristics at 180 days efficacious inhibition of neointimal proliferation in porcine coronary arteries with low inflammation responses and a BMS-like endothelialization at 180 days. In addition, in an in vitro model, the PF-SES also confirmed low thrombogenicity as compared with the EES.
无聚合物药物洗脱支架（DES）没有永久性聚合物涂层，可能与血管快速愈合有关，这为减少双联抗血小板治疗（DAPT）提供了理论依据。本研究的目的是比较无聚合物西罗莫司洗脱支架（PF-SES）、其裸金属支架（BMS）类似物与已证实对猪冠状动脉有效的永久性聚合物基西罗莫司洗脱支架（SES）的血管愈合情况。
使用超薄钴铬PF-SES、其BMS类似物和一种永久性聚合物的SES来研究血管愈合及其抗狭窄潜力。将支架植入猪冠状动脉，在7天、28天和180天时进行组织病理学分析。在另一项体外研究中，将PF-SES的血栓形成性与氟聚合物涂层依维莫司洗脱支架（EES）进行比较，EES在众多研究中显示出较低的支架血栓形成率。
在动物研究中，所有研究组的新生内膜生长和损伤评分最低，内膜和外膜的炎症评分较低。28天后，与SES和BMS相比，PF-SES的新生内膜面积最低（分别为1.48±0.55mm²、2.43±0.69mm²和1.90±0.85mm²，p<0.05），所有组管腔表面的内皮化几乎完成，尽管SES的覆盖最少，偶尔有粘附的管腔炎症细胞（p>0.05）。在180天时，SES的新生内膜面积和厚度最为明显（p<0.05），与BMS植入相当，其特征是血管愈合几乎完成。与永久性聚合物基SES相比，PF-SES和BMS具有完全的内皮化、无纤维蛋白且炎症反应持续较低（炎症评分：PF-SES为0.41±0.74，SES为2.52±1.72，BMS为0.30±0.65，BMS与SES相比，p<0.05）。肉芽肿形成和纤维蛋白积累在SES中最为明显，但未达到统计学意义，p>0.05）。在体外血栓形成性研究中，与EES相比，PF-SES在纤维蛋白和血小板结合以及血小板聚集参数方面证实了类似的抗血栓形成特性。
与BMS相比，超薄钴铬PF-SES在28天时显示出类似的内皮化，在180天时具有可比的愈合特征，能有效抑制猪冠状动脉新生内膜增殖，炎症反应低，在180天时具有类似BMS的内皮化。此外，在体外模型中，与EES相比，PF-SES也证实了低血栓形成性。
