一种永久性聚合物Zotarolimus-Eluting支架与一种无聚合物Amphilimus-Eluting支架的随机全方位评估
Rik Rozemeijer1, Mera Stein1,2, Michiel Voskuil1
1Departments of Cardiology (R.R., M.S., M.V., S.K., G.E.L., L.T., S.Z.R., A.O.K., P.A., P.A.D., P.S.), University Medical Center Utrecht, The Netherlands.
Circulation
|December 28, 2018
概括
无聚合物两释放支架 (PF-AES) 与永久聚合物两释放支架 (PP-ZES) 在预防损失方面没有劣势. 这项大型试验证明了新型PF-AES技术在冠状动脉干预中的安全性和有效性.
科学领域:
- 心血管医学
- 干预心脏病学
- 生物材料科学
背景情况:
- 新型无聚合物化支架 (PF-AES) 为药物化支架提供了替代的化技术.
- 现有有限的大规模随机数据将PF-AES与当前的永久聚合物佐塔洛分泌支架 (PP-ZES) 相比较.
研究的目的:
- 在接受穿皮冠状动脉干预的全新人群中评估PF-AES与PP-ZES的非劣势.
- 评估两种支架类型的临床安全性和疗效.
主要方法:
- 一个前性,多中心的,随机的,非劣势性试验,涉及1502名患者.
- 患者被随机分为1:1接受PP- ZES或PF- AES,分层分别对待热素状况和糖尿病.
- 主要终点是12个月的目标损伤衰竭,定义为心脏死亡,目标血管心肌梗塞或目标损伤再血管化.
主要成果:
- PF- AES与PP- ZES没有劣势,PF- AES接受者的6. 2%与PP- ZES接受者的5. 6%发生损失 (风险差异为0. 5%,上限95%CI为2. 6%).
- 目标血管心肌梗塞和目标损伤再血管化的发病率在两组之间相似.
- 确定的或可能的支架血栓发生在1. 0%的患者中.
结论:
- 在12个月的目标损伤失方面,无聚合物放的支架与永久聚合物放的支架无差.
- 这项研究支持PF-AES作为冠状动脉干预的可行选择的临床安全性和有效性.
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