Shimoda Tomonari, Miyamoto Yoshihisa, Shimamura Junichi, Ueyama Hiroki, Yokoyama Yujiro, Sá Michel Pompeu, Kaneko Tsuyoshi, Ando Tomo, Takagi Hisato, Fukuhara Shinichi, Kuno Toshiki
School of Medicine, University of Tsukuba, Ibaraki, Japan.
Division of Nephrology and Endocrinology, University of Tokyo, Tokyo, Japan.
Ann Cardiothorac Surg. 2025 Mar 31;14(2):73-84. doi: 10.21037/acs-2024-etavr-0096. Epub 2024 Dec 6.
Transcatheter aortic valve replacement (TAVR) is an established alternative to surgical aortic valve replacement (SAVR) for severe symptomatic aortic stenosis (AS), including low-risk patients. We aimed to update a systematic review and conduct a meta-analysis of reconstructed time-to-event data from randomized control trials (RCTs) in low-/intermediate-risk patients.
Systematic searches were performed in PubMed, EMBASE, Cochrane CENTRAL, and specific websites up to November 2023, for RCTs. A meta-analysis was performed using the reconstructed time-to-event data from the provided Kaplan-Meier (KM) curves from the included RCTs. The primary outcome was all-cause mortality, and the secondary outcomes included a composite outcome (all-cause mortality and disabling stroke), and heart failure rehospitalization. Landmark analysis for endpoints beyond 1 year was performed. The study protocol was registered on PROSPERO (CRD42023487893).
Six RCTs with a total of 7,389 patients were included. The survival was comparable between both groups [hazard ratio (HR), 1.03; 95% confidence interval (CI): 0.93-1.14; P=0.57]. The composite outcome and heart failure rehospitalization were comparable between the two groups. Lower mortality with TAVR was observed compared to SAVR before 1 year (HR, 0.82; 95% CI: 0.68-0.98; P=0.03), while TAVR was associated with higher risk of mortality beyond 1 year (HR, 1.13; 95% CI: 1.01-1.27; P=0.04). Similarly, the TAVR group was associated with lower risk for the composite endpoint and heart failure rehospitalization before 1 year, but with higher rates beyond 1 year.
Among low- to intermediate-risk patients, TAVR was found to be associated with favorable outcomes in the short-term (0-1 year). However, our landmark analysis demonstrated TAVR to be associated with poorer outcomes beyond 1 year.
经导管主动脉瓣置换术(TAVR)是治疗严重症状性主动脉瓣狭窄(AS)的一种既定替代手术主动脉瓣置换术(SAVR)的方法,包括低风险患者。我们旨在更新一项系统评价,并对低/中风险患者随机对照试验(RCT)的重构事件发生时间数据进行荟萃分析。
截至2023年11月,在PubMed、EMBASE、Cochrane CENTRAL和特定网站上对RCT进行系统检索。使用纳入的RCT提供的Kaplan-Meier(KM)曲线中的重构事件发生时间数据进行荟萃分析。主要结局是全因死亡率,次要结局包括复合结局(全因死亡率和致残性卒中)以及心力衰竭再住院。对1年以上的终点进行了里程碑分析。该研究方案已在PROSPERO(CRD42023487893)上注册。
纳入了6项RCT,共7389例患者。两组的生存率相当[风险比(HR),1.03;95%置信区间(CI):0.93-1.14;P=0.57]。两组的复合结局和心力衰竭再住院情况相当。与SAVR相比,TAVR在1年之前观察到较低的死亡率(HR,0.82;95%CI:0.68-0.98;P=0.03),而TAVR在1年之后与较高的死亡风险相关(HR,1.13;95%CI:1.01-1.27;P=0.04)。同样,TAVR组在1年之前与复合终点和心力衰竭再住院的较低风险相关,但在1年之后发生率较高。
在低至中风险患者中,发现TAVR在短期(0-1年)与良好结局相关。然而,我们的里程碑分析表明,TAVR在1年之后与较差结局相关。