在BEST-CLI试验中,针对慢性肢体威胁性缺血的开放式和内血管再血管化后的二次干预
Michael S Conte1, Ezana Azene2, Gheorghe Doros3
1Division of Vascular and Endovascular Surgery, University of California, San Francisco, San Francisco, CA.
Journal of vascular surgery
|February 18, 2024
概括
与内血管治疗相比,开放式旁路手术显著减少了慢性肢体威胁性缺血症患者重复手术的需要. 这尤其适用于可用的大阴静脉移植,导致更少的重复干预.
科学领域:
- 血管外科 血管外科
- 干预心脏病学 干预心脏病学
- 临床试验 临床试验
背景情况:
- 慢性四肢威胁性缺血症 (CLTI) 经常需要重新血管化.
- 接受CLTI重血管化的患者通常需要随后的目标肢体重新干预.
- 关键四肢缺血症患者的最佳内血管与最佳外科治疗 (BEST-CLI) 试验提供了一个比较治疗策略的平台.
研究的目的:
- 分析初始开放式绕道 (OPEN) 与内血管 (ENDO) 治疗CLTI后的再干预率.
- 为了比较主要的再干预,任何再干预,以及复合的再干预,截肢或死亡的综合终点.
- 为了评估不同患者队伍的累积数量,随着时间的推移,重复干预的累积数量.
主要方法:
- 计划对BEST-CLI随机试验数据进行二次分析.
- 治疗意图分析比较了OPEN和ENDO策略在两个队列中:有 (队列1) 和没有 (队列2) 合适的单段大沙芬静脉 (SSGSV).
- 用单变量和多变量考克斯回归模型进行比较.
主要成果:
- 开放治疗与显著较低的重大再干预率,任何再干预率和两组队伍的复合终点相关.
- 早期 (30天) 的重新干预在ENDO组比OPEN组在两个队列中都更高.
- 每年重新干预的平均数量在OPEN中显著下降,特别是在第1组 (SSGSV).
结论:
- 在CLTI的重血管化后,重新干预是常见的现象.
- 最初的开放式旁路手术,特别是SSGSV,与内血管治疗相比,目标肢体再干预的负担要低得多.
- 治疗选择对CLTI患者的长期再干预率产生重大影响.
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