Transcatheter or Surgical Treatment of Patients With Aortic Stenosis at Low to Intermediate Risk: An Individual Participant Data Meta-Analysis.

However, limitations in study design and statistical power raise concerns about the generalizability of individual randomized clinical trials (RCTs) comparing TAVI and surgical aortic valve replacement (SAVR) to routine clinical practice.

然而，研究设计和统计能力的局限性引发了对将TAVI与外科主动脉瓣置换术（SAVR）进行比较的个别随机临床试验（RCTs）推广到常规临床实践的普遍性的担忧。

Background

To compare 1-year outcomes of TAVI vs SAVR in patients with severe symptomatic aortic stenosis at low to intermediate surgical risk applying a 2-stage individual participant data (IPD) and aggregate meta-analyses.

为了比较低至中等手术风险的严重症状性主动脉瓣狭窄患者在经导管主动脉瓣置换术（TAVI）与外科主动脉瓣置换术（SAVR）1年结果，应用了两阶段的个体患者数据（IPD）和汇总的荟萃分析。

data_sources

MEDLINE databases were searched for RCTs comparing TAVI and SAVR in patients with aortic stenosis until June 15, 2025.

在MEDLINE数据库中检索了比较TAVI和SAVR在主动脉瓣狭窄患者中的随机对照试验（RCTs），直到2025年6月15日。

study_selection

RCTs were selected comparing TAVI vs SAVR in patients with severe symptomatic aortic stenosis at low or intermediate surgical risk with 1-year follow-up.

选择比较经导管主动脉瓣置换术（TAVI）与外科主动脉瓣置换术（SAVR）的随机对照试验（RCTs），研究对象为低或中等手术风险的严重症状性主动脉瓣狭窄患者，随访时间为1年。

data_extraction_and_synthesis

IPD were obtained from all investigator-initiated RCTs (DEDICATE, NOTION, NOTION-2, and UK TAVI) and analyzed in 1- and 2-stage IPD meta-analyses.

从所有研究者发起的随机对照试验（DEDICATE、NOTION、NOTION-2和UK TAVI）中获取个体患者数据（IPD），并在1阶段和2阶段IPD荟萃分析中进行分析。

An overall meta-analysiswas performed by adding aggregate data from industry-sponsored RCTs.

通过汇总来自行业资助的随机对照试验(RCTs)的聚合数据，进行了总体的荟萃分析。

main_outcomes_and_measures

The primary end point was all-cause death or any stroke 1 year after randomization.

主要终点是一年随机化后所有原因的死亡或任何中风。

Secondary end points included all-cause death, any stroke, disabling stroke, cardiovascular death, rehospitalization for cardiovascular cause, myocardial infarction, new-onset atrial fibrillation, new permanent pacemaker implantation, and aortic valve reintervention.

次要终点包括全因死亡、任何中风、致残性中风、心血管死亡、因心血管原因再次住院、心肌梗死、新发房颤、新植入永久性起搏器和主动脉瓣再次干预。

Results

The IPD meta-analysisincluded 4 RCTs comprising 2873 patients (mean [SD] age, 76.7 [5.5] years; 805 [56.1%] male) at low to intermediate surgical risk randomly assigned to TAVI (n = 1439) or SAVR (n = 1434).

个体患者数据(IPD)荟萃分析包括了4项随机对照试验(RCTs)，共纳入2873名患者（平均[标准差]年龄为76.7[5.5]岁；805名[56.1%]为男性），这些患者手术风险低至中等，被随机分配接受经导管主动脉瓣置换术(TAVI)（n = 1439）或外科主动脉瓣置换术(SAVR)（n = 1434）。

At 1 year, the hazard ratio(HR) for the primary end point for TAVI compared to SAVR was 0.73 (95% CI, 0.56-0.95) in the 1-stage and 0.79 (95% CI, 0.49-1.27) in the 2-stage IPD meta-analysis.

在1年时，经导管主动脉瓣置换术（TAVI）与外科主动脉瓣置换术（SAVR）的主要终点风险比（HR）在单阶段分析中为0.73（95%置信区间，0.56-0.95），在双阶段个体患者数据（IPD）荟萃分析中为0.79（95%置信区间，0.49-1.27）。

In the 2-stage overall meta-analysisthe HR for the primary end point was 0.76 (95% CI, 0.60-0.97).

在双阶段总体荟萃分析中，主要终点的风险比（HR）为0.76（95%置信区间，0.60-0.97）。

conclusions_and_relevance

In this IPD meta-analysisof 4 RCTs, and an overall meta-analysisof 8 RCTs of patients with severe symptomatic AS at low to intermediate risk, TAVI was associated with a reduction in the 1-year incidenceof all-cause death or any stroke.

在这项包含4项随机对照试验（RCTs）的个体患者数据（IPD）荟萃分析，以及8项随机对照试验的总体荟萃分析中，针对低至中等风险的严重症状性主动脉瓣狭窄（AS）患者，经导管主动脉瓣植入术（TAVI）与1年内全因死亡或任何中风发生率的降低相关。

These findings emphasize TAVI as alternative option in patients at low to intermediate risk.

这些发现强调了在低至中等风险患者中，TAVI作为替代选项的重要性。

Long-term follow-up is warranted to evaluate sustainability of these findings.

需要长期随访以评估这些发现的可持续性。