大动脉置换试验中手术对照的代表性:与常规手术队列进行比较
Anton Tomsic1, Bart J J Velders2, Michal J Kawczynski3,4
1Department of Cardiothoracic Surgery, Augsburg University Medical Centre, Ausburg, Germany.
Heart (British Cardiac Society)
|July 9, 2025
概括
临床试验中的外科动脉置换 (SAVR) 患者比常规实践中的患者有更多的并发症和更差的存活率. 这些发现挑战了将SAVR与跨导管大动脉植入 (TAVI) 进行比较的试验的概括性.
科学领域:
- 心血管医学 心血管医学
- 干预心脏病学 干预心脏病学
- 临床试验 临床试验
背景情况:
- 随机对照试验 (RCT) 比较过导管大动脉植入 (TAVI) 和手术大动脉置换 (SAVR) 已经形成了大动脉狭窄的治疗指南.
- 这些试验中的SAVR手臂中的患者群体可能不准确地代表在现实临床环境中接受SAVR的患者.
研究的目的:
- 在关键RCT中批判性地评估SAVR患者的代表性.
- 为了比较SAVR患者在RCT中的特征和结果与常规临床实践中的特征和结果.
主要方法:
- 自2010年以来,对RCT和大型前性研究 (≥500名SAVR患者) 的系统文献综述.
- 在RCT SAVR队列和常规实践队列之间比较患者特征,早期结果和5年生存期.
- 分析和重建的卡普兰-梅尔生存分析,按风险类别分层.
主要成果:
- 分析了包括74,797名SAVR患者在内的19项研究.
- 常规实践SAVR患者的早期死亡率相似,但与RCTSAVR患者相比,外围手术并发症 (中风,心脏起器植入,心肌梗塞) 较少.
- 与RCT SAVR患者相比,常规实践SAVR患者的五年生存率在低风险 (HR 0.64) 和中等风险 (HR 0.55) 组中显著更高.
结论:
- 在RCT中,SAVR患者的并发症率高,长期存活率低于常规实践患者,尽管基线外科风险相似或较低.
- 由于患者群体和结果的差异,SAVR与TAVI试验的外部有效性受到质疑.
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