在接受穿皮冠状动脉干预的患者中,无聚合物与可生物降解聚合物药物排泄支架:一个评估者盲目的,非劣势的,随机对照试验
Raffaele Piccolo1, Paolo Calabrò2, Greta Carrara3
1Department of Advanced Biomedical Sciences, University of Naples "Federico II", Naples, Italy.
概括
在穿皮冠状动脉干预 (PCI) 过程中,无聚合物两流体排泄支架 (AES) 显示与可生物降解聚合物恒流体排泄支架 (EES) 不相差. 然而,无聚合物AES与早期支架血栓形成的风险较高有关.
科学领域:
- 心血管医学 心血管医学
- 干预心脏病学 干预心脏病学
- 生物材料科学 生物材料科学
背景情况:
- 关于穿皮冠状动脉干预 (PCI) 中无聚合物释放药物支架的数据有限.
- 评估新型支架技术对于改善PCI结果至关重要.
研究的目的:
- 为了比较一种无聚合物两释放性支架 (AES) 与一种可生物降解的聚合物恒释放性支架 (EES) 的疗效和安全性.
- 评估心血管死亡,目标血管心肌梗塞或1年随访时目标损伤再血管化的初级终点.
主要方法:
- 一个随机的,评估者盲目的,非劣等性试验,涉及14家意大利医院的2,107名患者.
- 患者被分配到无聚合物AES或生物降解聚合物EES.
- 主要终点是心血管死亡,目标血管MI或目标病变再血管化的复合结果.
主要成果:
- 无聚合物AES显示不劣于EES,主要终点发生在8.2%的AES患者和7.2%的EES患者中 (p=0.041).
- 在各组之间主要终点的各个组成部分中没有发现显著差异.
- 无聚合物AES的确定的或可能的支架血栓形成的频率更高 (1.0%vs0.3%,p=0.044),主要是由于30天内早期的血栓形成.
结论:
- 在1年的随访中,无聚合物AES与可生物降解聚合物EES在所有新来的PCI患者中没有劣势.
- 无聚合物AES表明早期支架血栓形成的风险增加,需要在临床实践中仔细考虑.
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