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选择对外周动脉疾病的治疗方法:注册和随机对照试验人口之间的差异

Niveditta Ramkumar¹, Philip P Goodney², Kayla Moore³

¹Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire.

The Journal of surgical research

|March 26, 2025

概括

绕道手术的长期死亡率低于关键四肢缺血的内血管治疗,即使考虑到患者之间的差异. 注册表数据分析支持现实世界的比较有效性研究.

科学领域:

血管外科血管外科
医疗保健服务研究医疗服务研究
临床试验临床试验

背景情况:

随机试验参与者往往不同于现实世界患者群体.
了解不同患者群体的比较疗效对于临床决策至关重要.

研究的目的:

为了比较随机试验 (BEST-CLI) 和大型现实世界注册表 (VQI) 之间的患者特征和治疗结果.
评估使用注册表数据与先进的统计方法进行比较有效性研究的有效性.

主要方法:

描述性统计和考克斯回归被用来比较1815名BEST-CLI患者与104,877名内血管和32,120名从VQI注册 (2014-2020年) 的绕道患者.
反向概率权重与倾向性得分,根据试验和注册表之间的患者特征差异进行调整.

主要成果:

与BEST-CLI参与者相比,VQI患者年龄较大,女性更频繁,非西班牙裔族裔.
在加权后,在VQI队列中,内血管治疗 (26.3%) 与旁路治疗 (23.7%) 的5年死亡率更高.
与内血管治疗相比,绕道与8%较低的死亡风险 (HR=0.92,P=0.005) 相关.

结论:

在BEST-CLI试验和VQI注册表中的患者之间存在显著差异.
权重注册数据分析产生了类似的治疗效果估计,支持其用于现实世界的比较问题.

关键词:

慢性肢体威胁性缺血症可能会导致肢体缺血.临床登记册临床登记册临床登记册周围动脉疾病是什么?随机对照试验是随机对照试验.

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