Wang Yu, Zhang Xiaowen, Zhang Xinlin, Xu Wei
Department of Cardiology, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, China.
Endocrine and Metabolic Disease Medical Center, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, China.
Front Cardiovasc Med. 2025 Mar 6;12:1479200. doi: 10.3389/fcvm.2025.1479200. eCollection 2025.
Previous reports of longer-term outcomes of transcatheter aortic valve implantation (TAVI) focus on higher risk patients and suggest potential temporal changes.
To evaluate the longer-term and temporal performances of TAVI compared to surgical aortic valve replacement (SAVR).
Randomized controlled trials reporting outcomes with at least 1-year follow-up. The primary outcome was the composite of all-cause death or disabling stroke.
We included 8 trials with 8,749 patients. TAVI was associated with a higher risk of longer-term (5-year) primary outcome compared to SAVR among higher-risk [odds ratio (OR), 1.25; 95% CI, 1.07-1.47] but not lower-risk participants [1.0 (0.77-1.29)]. However, a significant temporal interaction was detected in both risk profiles. TAVI with balloon-expandable valves was associated with a higher risk of longer-term primary outcome compared to SAVR [1.38 (1.2-1.6)], whereas no statistical difference was found with self-expanding valves [1.03 (0.89-1.19)]. There was a significant interaction between the two valve systems, and a temporal interaction was detected in both systems. Overall landmark analysis revealed a lower risk in TAVI within the initial 30 days [0.76 (0.6, 0.96)], comparable between 30 days to 2 years [1.04 (0.85, 1.28)], and higher beyond 2 years [1.36 (1.15-1.61)]. Analysis for all-cause death generated largely similar results.
TAVI was associated with a higher longer-term risk of primary outcome compared to SAVR in higher-risk patients and with balloon-expandable valves. However, a characteristic temporal interaction was documented in all subgroups. Future studies are warranted to test these findings.
先前关于经导管主动脉瓣植入术（TAVI）长期预后的报告主要关注高风险患者，并提示可能存在时间变化。
评估与外科主动脉瓣置换术（SAVR）相比，TAVI的长期及时间表现。
纳入至少随访1年的随机对照试验报告。主要结局为全因死亡或致残性卒中的复合结局。
我们纳入了8项试验，共8749例患者。在高风险参与者中，与SAVR相比，TAVI在长期（5年）主要结局方面风险更高[比值比（OR），1.25；95%置信区间（CI），1.07 - 1.47]，但在低风险参与者中并非如此[1.0（0.77 - 1.29）]。然而，在两种风险特征中均检测到显著的时间交互作用。与SAVR相比，球囊扩张瓣膜的TAVI在长期主要结局方面风险更高[1.38（1.2 - 1.6）]，而自膨胀瓣膜则未发现统计学差异[1.03（0.89 - 1.19）]。两种瓣膜系统之间存在显著交互作用，且在两个系统中均检测到时间交互作用。总体标志性分析显示，TAVI在最初30天内风险较低[0.76（0.6，0.96）]，在30天至2年之间相当[1.04（0.85，1.28）]，而在2年之后更高[1.36（1.15 - 1.61）]。全因死亡分析得出了大致相似的结果。
在高风险患者和使用球囊扩张瓣膜的情况下，与SAVR相比，TAVI在主要结局方面长期风险更高。然而，在所有亚组中均记录到了特征性的时间交互作用。未来研究有必要验证这些发现。
