Pérez de Prado Armando, Pérez Martínez Claudia, Cuellas Ramón Carlos, Regueiro Purriños Marta, López Benito María, Gonzalo Orden José Manuel, Rodríguez Altónaga José Antonio, Estévez Loureiro Rodrigo, Benito González Tomás, Viñuela Baragaño David, Molina Crisol María, Amorós Aguilar Marc, Pérez Serranos Isabel, Vidal Parreu Arnau, Benavides Montegordo Ana, Duocastella Codina Luis, Fernández Vázquez Felipe
Grupo Cardiovascular (HemoLeon), Fundación Investigación Sanitaria en León y del Instituto de Biomedicina (IBIOMED), Universidad de León, Hospital Universitario de León, León, Spain.
Grupo Cardiovascular (HemoLeon), Fundación Investigación Sanitaria en León y del Instituto de Biomedicina (IBIOMED), Universidad de León, Hospital Universitario de León, León, Spain.
Rev Esp Cardiol (Engl Ed). 2017 Dec;70(12):1059-1066. doi: 10.1016/j.rec.2017.05.021. Epub 2017 Jun 21.
New drug-eluting stents (DES) designed to overcome the limitations of existing devices should initially be tested in preclinical studies. Our objective was to analyze the safety and efficacy of new biodegradable polymer-based DES compared with bare-metal stents (BMS) and commercially available DES in a model of normal porcine coronary arteries.
We randomly implanted 101 stents (BMS and biodegradable polymer-based sirolimus-eluting stents: 3 test stent iterations [BD1, BD2, and BD3], Orsiro, Biomime and Biomatrix) in the coronary arteries of 34 domestic pigs. Angiographic and histomorphometric studies were conducted 1 month (n = 83) and 3 months (n = 18) later.
The stents were implanted at a stent/artery ratio of 1.31 ± 0.21, with no significant differences between groups. At 1 month, the new test stents (BD1, BD2 and BD3) showed less late loss and angiographic restenosis, as well as lower histologic restenosis and neointimal area (P < .0005), than the BMS. There were no differences in endothelialization, vascular injury, or inflammation between the new test stents and BMS, although the new stents showed higher fibrin deposition (P = .0006). At 3 months, all these differences disappeared, except for a lower neointimal area with the new BD1 stent (P = .027). No differences at any time point were observed between the new test stents and commercially available controls.
In this preclinical model, the new biodegradable polymer-based DES studied showed less restenosis than BMS and no significant differences in safety or efficacy vs commercially available DES.
旨在克服现有器械局限性的新型药物洗脱支架（DES）最初应在临床前研究中进行测试。我们的目的是在正常猪冠状动脉模型中，分析新型可生物降解聚合物基DES与裸金属支架（BMS）和市售DES相比的安全性和有效性。
我们将101个支架（BMS和可生物降解聚合物基西罗莫司洗脱支架：3种测试支架迭代产品[BD1、BD2和BD3]、Orsiro、Biomime和Biomatrix）随机植入34只家猪的冠状动脉中。在1个月（n = 83）和3个月（n = 18）后进行血管造影和组织形态计量学研究。
支架以1.31±0.21的支架/动脉比例植入，各组之间无显著差异。在1个月时，新型测试支架（BD1、BD2和BD3）与BMS相比，显示出更少的晚期管腔丢失和血管造影再狭窄，以及更低的组织学再狭窄和新生内膜面积（P <.0005）。新型测试支架与BMS在内皮化、血管损伤或炎症方面没有差异，尽管新型支架显示出更高的纤维蛋白沉积（P =.0006）。在3个月时，所有这些差异均消失，除了新型BD1支架的新生内膜面积较低（P =.027）。在任何时间点，新型测试支架与市售对照之间均未观察到差异。
在该临床前模型中，所研究的新型可生物降解聚合物基DES比BMS显示出更少的再狭窄，并且在安全性或有效性方面与市售DES无显著差异。
