随机贝叶斯多中心COME-TAVI试验的推理和设计,用于新发病患者的左捆分支区块
Lena Rivard1, Isabelle Nault2, Andrew D Krahn3
1Department of Cardiology, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada.
CJC open
|September 18, 2023
概括
这项研究比较了通过电生理学引导的管理与30天的监测对患者新的左捆分支堵塞 (LBBB) 经过透气管大动脉植入 (TAVI). 目标是确定预防心脏不良事件的最佳策略.
科学领域:
- 心脏病学 心脏病学
- 电子生理学 电子生理学
- 干预心脏病学 干预心脏病学
背景情况:
- 跨导管大动脉植入 (TAVI) 后新出现的左捆支部阻塞 (LBBB) 增加了延迟心房阻塞的风险.
- 目前LBBB后TAVI的管理策略没有标准化,仍然存在争议.
研究的目的:
- 为了比较电生理学研究 (EPS) 引导方法与30天心电图监测策略的临床有效性,用于在TAVI后管理新发性LBBB.
- 通过评估包括心脏死亡,昏迷和导电障碍在内的复合终点来评估净临床益处.
主要方法:
- 一个贝叶斯的多中心随机试验 (COME-TAVI),比较EPS引导的管理与30天的连续心电图监测.
- 在TAVI后的第二天,患有持续性LBBB的患者被随机分类.
- 在EPS引导的手臂中,如果His-ventricle (HV) 间隔≥65毫秒,则需要植入心脏起器.
主要成果:
- 试验正在进行中,在两个管理策略之间比较主要不良事件的复合结果.
- 这项研究使用了结果适应性随机化和中间分析.
- 招募目标是452名患者在12个月内达到77个主要结果事件.
结论:
- COME-TAVI试验旨在提供基于证据的指导,用于管理TAVI后LBBB的新发病.
- 研究结果将为临床决策提供有关心脏起器植入与监测的信息.
- 这项研究解决了TAVI后患者护理的关键未满足需求.
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