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一项随机试验的最终3年结果,比较自扩展到气球可扩展的跨导管大动脉的随机试验

Jonas Lanz¹, Helge Möllmann², Won-Keun Kim³

¹Department of Cardiology, Inselspital, Bern University Hospital, Switzerland (J.L., S.S., S.W., T.P.).

Circulation. Cardiovascular interventions

|July 7, 2023

概括

与SAPIEN 3 (S3) 相比,使用ACURATE neo (NEO) 进行过导管大动脉植入显示了类似的3年结果. 假肢反的早期差异没有影响长期的临床结果或生物假肢失败.

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
生物材料科学生物材料科学

背景情况:

在SCOPE I试验中,最初发现ACURATE neo (NEO) 在30天内没有达到与SAPIEN 3 (S3) 的非劣质性.
在NEO早期术后观察到更高的假体反和急性损伤率.
关于NEO设备的长期耐用性和临床结果的数据有限.

研究的目的:

评估NEO和S3跨导管大动脉植入 (TAVI) 之间的早期差异是否转化为长期的临床结果差异.
在TAVI后3年,对两种器件评估生物假体门故障率.
为了比较NEO和S3之间的3年临床结果,包括死亡率,中风,心力衰竭住院和重新干预,NEO和S3.

主要方法:

一项随机试验 (SCOPE I) 涉及患有严重大动脉狭窄症的患者,接受血液输血TAVI.
用对待意向分析与考克斯比例或细灰分布危险模型比较3年后的临床结果.
报告生物假体门故障的门植入队列.

主要成果:

在3年后,NEO (24.3%) 和S3 (25%) 组 (HR,0.98) 之间的所有原因死亡率相似.
在NEO和S3组之间,中风 (SHR,1.04) 和心力衰竭住院 (SHR,0.74) 的发生率也相似.
大动脉的重新干预是罕见的和相似的 (4在NEO和3在S3). 3年后,NEO (8 mm Hg) 与S3 (12 mm Hg) 的平均梯度仍然较低.

结论:

在ACURATE neo和SAPIEN 3设备之间早期观察到的差异并没有导致三年临床结果的显著差异.
在两种跨导管大动脉植入装置之间,直到3年的随访点,生物假体失效率在两种跨导管大动脉植入装置之间是相似的.
尽管最初存在担忧,但NEO和S3的长期临床性能在3年后似乎相似,NEO的持续较低梯度.

关键词:

塔维 (Tavi) 是一个古老的城市.在TAVRR中,我们可以看到.生物假体生物假体随机化试验是一个随机化试验.通过导管的心脏门.

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