随机试验评估慢性冠状动脉干预治疗
Seung-Whan Lee1, Pil Hyung Lee1, Jung-Min Ahn1
1Department of Cardiology (S-W.L., P.H.L., J.-M.A., D.-W.P., H.K., S.-J.K., Y.-H.K., C.W.L., S.-W.P., S.-J.P.), Center for Medical Research and Information, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
Circulation
|March 1, 2019
概括
通过皮肤进行冠状动脉干预 (CTO-PCI) 是可行的,成功率很高. 然而,这项研究发现CTO- PCI与没有CTO- PCI策略之间的重大心血管不良事件没有显著差异.
科学领域:
- 心脏病学
- 干预心脏病学
- 临床试验
背景情况:
- 慢性全封闭性冠状动脉干预 (PCI) 已取得进展,趋向于更全面的再血管化.
- 支持CTO-PCI的证据主要来自观察性研究和小型试验,需要进一步调查.
研究的目的:
- 在符合条件的患者中,评估CTO-PCI与没有CTO-PCI的策略的疗效和安全性.
- 评估CTO-PCI对36个月的健康相关生活质量的影响.
主要方法:
- 这是一项开放式,多中心,随机的非劣势性试验,涉及834名患者.
- 患者被分配到CTO- PCI或没有CTO- PCI,可以选择PCI或非CTO病变.
- 主要终点是死亡,心肌梗塞,中风或任何重血管化;生命质量也被评估.
主要成果:
- 在CTO- PCI中,成功率为90. 6%,其中3名患者出现严重并发症.
- 在CTO-PCI (22. 3%) 组和没有CTO-PCI (22. 4%) 组之间,主要终点发生率没有显著差异,平均随访时间为4. 0年.
- 这两种策略在疾病特异性健康状况上都显示出相似的改善,但两组之间没有显著的差异.
结论:
- CTO-PCI是一个可行的程序,成功率高.
- 这项研究表明CTO- PCI与没有CTO- PCI之间主要心血管不良事件没有显著差异.
- 其中的局限性包括临床终点的低统计能力和不同组的高交叉率.
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