低风险大动脉置换试验和外科注册表之间的结果比较
Makoto Mori1,2, Kayoko Shioda3,4, Christina Waldron1
1Division of Cardiac Surgery, Yale School of Medicine, New Haven, Connecticut.
JAMA network open
|January 6, 2025
概括
在现实环境下进行大动脉置换手术 (SAVR) 显示,与PARTNER 3和Evolut Low Risk等低风险试验相比,30天死亡率相似,但中风率较低.
科学领域:
- 心血管外科心血管外科
- 干预心脏病学 干预心脏病学
- 医疗保健服务研究 医疗服务研究
背景情况:
- 低风险的大动脉置换试验的结果可能不完全代表现实世界手术结果.
- 同时的心脏手术增加了非试验环境中的外科主动脉置换 (SAVR) 结果的复杂性.
研究的目的:
- 在国家手术数据库中进行SAVR的患者与低风险大动脉置换试验中的患者之间比较30天死亡率和中风率.
- 评估来自PARTNER 3和Evolut低风险试验的研究结果对更广泛的外科患者群体的概括性.
主要方法:
- 一项横截面研究使用了2016-2018年美国胸部外科医生协会成人心脏手术数据库 (STS ACSD).
- 基于概率的抽样从STS ACSD创建了1000个患者队列,与试验参与者的预测死亡风险 (PROM) 相匹配.
- 从采样的STS ACSD队列中,30天死亡率和中风率与PARTNER 3和Evolut低风险试验的SAVR臂进行了比较.
主要成果:
- 该研究分析了25811名接受SAVR的低风险患者,平均年龄为71岁,男性65%.
- 采样的STS ACSD队伍的平均30天死亡率为1.39%,与PARTNER 3 (1.1%) 和Evolut Low Risk (1.3%) 相比.
- 抽样队伍中中风率为1.25%,明显低于PARTNER 3 (2.4%) 和Evolut低风险 (3.4%) 的情况.
结论:
- 低风险患者的真实世界SAVR显示30天死亡率与主要临床试验相当.
- 与试验数据相比,真实世界SAVR队列中中风的发生率较低.
- 结果表明,在低风险SAVR试验中报告的结果可以将其推广到更广泛的国家外科病患群体中.
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