在一个大型的未来多中心注册表中进行冠状动脉手术的远程辐射接入:KODRA试验
Jun-Won Lee1, Yongcheol Kim2, Bong-Ki Lee3
1Division of Cardiology, Department of Internal Medicine, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju, South Korea.
JACC. Cardiovascular interventions
|February 14, 2024
概括
远端辐射接入 (DRA) 在冠状动脉血管学和干预方面取得了很高的成功,并发症率较低. 弱脉冲和有限的操作员经验预测了这个大型注册表中的穿孔故障.
科学领域:
- 干预心脏病学 干预心脏病学
- 血管接入技术 血管接入技术
- 临床试验 临床试验
背景情况:
- 远距离辐射通道 (DRA) 是一种新兴的替代血管通道.
- 目前,关于DRA在常规实践中的安全性和有效性的证据有限.
研究的目的:
- 在日常临床实践中评估远端辐射接入 (DRA) 的安全性和可行性.
- 评估使用DRA的冠状动脉血管学 (CAG) 和皮肤冠状动脉干预 (PCI) 的成功率.
主要方法:
- 未来的多中心注册 (KODRA试验) 涉及14家医院的4977名患者.
- 主要终点:CAG和PCI的成功率. 二级终点:穿孔成功,交叉率,访问部位并发症,出血事件和穿孔失败预测因素.
主要成果:
- 通过DRA.通过CAG (100%) 和PCI (98.8%) 的高成功率.
- 在94.4%的病例中,成功地完成了远端辐射动脉穿刺.
- 偏远放射性动脉封闭率低 (0.8%),放射性动脉封闭率低 (0.8%),与DRA相关的出血率低 (3.3%),没有严重的血瘤.
结论:
- 远端辐射接入 (DRA) 对于冠状动脉手术来说是安全有效的,其成功率高,并发症率低.
- 穿孔失败的预测因素包括脉疲弱和操作员之前的DRA病例不到100例.
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