West China Hospital, Sichuan University, Chengdu, Sichuan, China.
The Chinese University of Hong Kong, Shenzhen, Guangdong, China.
PLoS One. 2019 Sep 24;14(9):e0221922. doi: 10.1371/journal.pone.0221922. eCollection 2019.
Transcatheter aortic valve implantation (TAVI) is an option for treatment for patients with severe aortic stenosis who are at high risk for death with surgical aortic valve replacement (SAVR). It is unknown whether TAVI can be safely introduced to intermediate- and low-risk patients.
To compare the efficacy and safety of TAVI and SAVR in patients with intermediate- and low-surgical risk.
Medline, Embase, and the Cochrane Central Register of Controlled Trials were searched from inception to April 15, 2019.
We included randomized controlled trials comparing TAVI with SAVR in patients with intermediate- and low-surgical risk.
Meta-analyses were conducted using random-effects models to calculate risk ratios (RR) with corresponding 95% confidence interval (CI). Two independent reviewers completed citation screening, data abstraction, and risk assessment. Primary outcome was a composite of all-cause mortality or disabling stroke at 12 months.
A total of 5 trials randomizing 6390 patients were included. In patients with low risk, TAVI was associated with a significant reduction in the composite of all-cause mortality or disabling stroke compared with SAVR (RR, 0.56; 95%CI, 0.40-0.79; I2 = 0%). This benefit was not replicated in patients with intermediate risk (RR, 0.96; 95% CI, 0.80-1.15; I2 = 0%). Similar results were seen separately in all-cause mortality and disabling stroke when TAVI was compared with SAVR.
For patients with severe aortic stenosis who were at low risk for death from surgery, TAVI achieved superior clinical outcomes compared to SAVR; however, these benefits were not seen in those with intermediate risk. This information may inform discussions about deciding between SAVR and TAVI for patients with low to intermediate risk separately.
经导管主动脉瓣植入术（TAVI）是一种治疗高危外科主动脉瓣置换术（SAVR）的严重主动脉瓣狭窄患者的选择。尚不清楚 TAVI 是否可安全用于中低危患者。
比较 TAVI 与 SAVR 在中低手术风险患者中的疗效和安全性。
从建库至 2019 年 4 月 15 日，检索了 Medline、Embase 和 Cochrane 中央对照试验注册库。
我们纳入了比较 TAVI 与 SAVR 治疗中低手术风险患者的随机对照试验。
使用随机效应模型进行荟萃分析，计算风险比（RR）及其相应的 95%置信区间（CI）。两名独立的审查员完成了引文筛选、数据提取和风险评估。主要结局为 12 个月时全因死亡率或致残性卒中的复合终点。
共纳入 5 项随机分配 6390 例患者的试验。在低危患者中，TAVI 与 SAVR 相比，全因死亡率或致残性卒中的复合终点显著降低（RR，0.56；95%CI，0.40-0.79；I²=0%）。但在中危患者中未复制这一结果（RR，0.96；95%CI，0.80-1.15；I²=0%）。当 TAVI 与 SAVR 比较时，全因死亡率和致残性卒中也分别有类似的结果。
对于手术死亡风险低的严重主动脉瓣狭窄患者，TAVI 与 SAVR 相比可获得更好的临床结局；但中危患者则无此获益。这些信息可能有助于分别讨论低危至中危患者选择 SAVR 与 TAVI。
