近日，美国哥伦比亚大学欧文医学中心Martin B. Leon团队研究了严重症状性主动脉瓣狭窄的低风险患者经导管或手术主动脉瓣置换术后7年的效果与安全性。2025年10月27日出版的《新英格兰医学杂志》发表了这项最新研究成果。

PARTNER 3试验的5年数据显示，在严重症状性主动脉瓣狭窄的低风险患者中，经导管主动脉瓣置换术（TAVR）患者和手术主动脉瓣置换术患者的结局相似。但需要对临床结局和瓣膜耐久性进行长期评估。

患者按1:1的比例随机分配，接受经股TAVR或手术。第一个主要终点是与手术、瓣膜或心力衰竭相关的死亡、中风或再住院的非分级复合。第二个主要终点是死亡、致残性卒中、非致残性卒中以及与手术、瓣膜或心力衰竭相关的再住院天数的分层复合，使用赢比分析进行分析。临床、超声心动图、瓣膜耐久性和健康状况终点在7年内进行评估。

共1000例患者接受随机分组。在第一个主要终点的分析中，终点事件发生率的Kaplan-Meier估计值在TAVR组为34.6%，在手术组为37.2%（差异为2.6个百分点；95%可信区间为9.0 - 3.7）。第二个主要终点的优势比为1.04 （95% CI， 0.84至1.30）。分别在TAVR组和手术组中，第一主要终点组成部分的Kaplan-Meier估计发生率如下：死亡，19.5%和16.8%；中风，8.5%和8.1%；再住院率分别为20.6%和23.5%。超声心动图评估的7年主动脉瓣梯度平均值（±SD）为TAVR术后13.1±8.5 mm Hg，术后12.1±6.3 mm Hg。TAVR组和手术组生物瓣膜失败率分别为6.9%和7.3%。两组患者报告的结果相似。

研究结果表明，在严重症状性主动脉瓣狭窄的低风险患者中，在7年时，TAVR组和手术组在死亡、卒中和再住院这两个主要复合终点方面没有观察到显著差异。

附：英文原文

Title: Transcatheter or Surgical Aortic-Valve Replacement in Low-Risk Patients at 7 Years

Author: Martin B. Leon, Michael J. Mack, Philippe Pibarot, Rebecca T. Hahn, Vinod H. Thourani, S.H. Kodali, Philippe Généreux, Samir R. Kapadia, David J. Cohen, Stuart J. Pocock, Yiran Zhang, Molly Szerlip, Julien Ternacle, S. Chris Malaisrie, Howard C. Herrmann, Wilson Y. Szeto, Mark J. Russo, Vasilis Babaliaros, Tamim Nazif, John G. Webb, Raj R. Makkar

Issue&Volume: 2025-10-27

Abstract:

BACKGROUND

Five-year data from the PARTNER 3 trial showed that among low-risk patients with severe, symptomatic aortic stenosis, outcomes were similar among patients who had undergone transcatheter aortic-valve replacement (TAVR) and those who had undergone surgical aortic-valve replacement. Longer-term assessments of clinical outcomes and valve durability are needed.

METHODS

Patients were randomly assigned in a 1:1 ratio to undergo transfemoral TAVR or surgery. The first primary end point was a nonhierarchical composite of death, stroke, or rehospitalization related to the procedure, the valve, or heart failure. The second primary end point was a hierarchical composite of death, disabling stroke, nondisabling stroke, and the number of rehospitalization days related to the procedure, the valve, or heart failure, analyzed with the use of a win ratio analysis. Clinical, echocardiographic, valve-durability, and health-status end points were assessed through 7 years.

RESULTS

A total of 1000 patients underwent randomization. In the analysis of the first primary end point, the Kaplan–Meier estimate of the incidence of an end-point event was 34.6% with TAVR and 37.2% with surgery (difference, 2.6 percentage points; 95% confidence interval [CI], 9.0 to 3.7). The win ratio for the second primary end point was 1.04 (95% CI, 0.84 to 1.30). In the TAVR and surgery groups, respectively, the Kaplan–Meier estimates for the incidence of components of the first primary end point were as follows: death, 19.5% and 16.8%; stroke, 8.5% and 8.1%; and rehospitalization, 20.6% and 23.5%. The mean (±SD) aortic-valve gradients assessed by echocardiography at 7 years were 13.1±8.5 mm Hg after TAVR and 12.1±6.3 mm Hg after surgery. The percentage of bioprosthetic valves that failed was 6.9% in the TAVR group and 7.3% in the surgery group. Patient-reported outcomes were similar in the two groups.

CONCLUSIONS

Among low-risk patients with severe, symptomatic aortic stenosis, no significant differences with respect to two primary composite end points involving death, stroke, and rehospitalization were observed at 7 years between those who had undergone TAVR and those who had undergone surgery.

DOI: NJ202510270000006

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2509766