美国德州Baylor Scott and White医学中心Michael J. Mack团队研究了经导管主动脉瓣置换术治疗低危症状性主动脉瓣狭窄患者的疗效与安全性。该研究于2023年10月24日发表在《新英格兰医学杂志》上。

该试验先前的一项分析显示，在手术风险较低的严重症状性主动脉瓣狭窄患者中，经导管主动脉瓣置换术（TAVR）在1年时的死亡、中风或再次住院的复合终点率显著低于主动脉瓣置换手术。长期预后尚不清楚。

研究组随机将患有严重症状性主动脉瓣狭窄且手术风险较低的患者分为接受TAVR或手术。第一主要终点是与瓣膜、手术或心力衰竭相关的死亡、中风或再次住院的复合终点。第二主要终点是分层综合，包括死亡、致残性中风、非致残性中风和再住院天数，使用胜率分析进行分析。对临床、超声心动图和健康状况的5年结局进行评估。

共有1000名患者接受了随机分组：503名患者被分配接受TAVR，497名患者接受手术。第一主要终点的组成部分发生在TAVR组496名患者中的111名和手术组454名患者的117名中（Kaplan–Meier估计，TAVR组为22.8%，手术组为27.2%；差异为−4.3个百分点；P=0.07）。第二主要终点的胜率为1.17（P=0.025）。第一主要终点组成部分的Kaplan–Meier估计如下：死亡，TAVR组为10.0%，手术组为8.2%；脑卒中分别为5.8%和6.4%；再住院率分别为13.7%和17.4%。根据平均（±SD）瓣膜梯度评估的瓣膜血液动力学性能，TAVR组为12.8±6.5 mm Hg，手术组为11.7±5.6 mm Hg。TAVR组3.3%的患者和手术组3.8%的患者发生了生物瓣膜失效。

研究结果表明，在接受TAVR或手术的严重症状性主动脉瓣狭窄的低风险患者中，两种主要复合结局在组间没有显著差异。

附：英文原文

Title: Transcatheter Aortic-Valve Replacement in Low-Risk Patients at Five Years | NEJM

Author: anonymous

Issue&Volume: 2023-10-24

Abstract:

Background

A previous analysis in this trial showed that among patients with severe, symptomatic aortic stenosis who were at low surgical risk, the rate of the composite end point of death, stroke, or rehospitalization at 1 year was significantly lower with transcatheter aortic-valve replacement (TAVR) than with surgical aortic-valve replacement. Longer-term outcomes are unknown.

Methods

We randomly assigned patients with severe, symptomatic aortic stenosis and low surgical risk to undergo either TAVR or surgery. The first primary end point was a composite of death, stroke, or rehospitalization related to the valve, the procedure, or heart failure. The second primary end point was a hierarchical composite that included death, disabling stroke, nondisabling stroke, and the number of rehospitalization days, analyzed with the use of a win ratio analysis. Clinical, echocardiographic, and health-status outcomes were assessed through 5 years.

Results

A total of 1000 patients underwent randomization: 503 patients were assigned to undergo TAVR, and 497 to undergo surgery. A component of the first primary end point occurred in 111 of 496 patients in the TAVR group and in 117 of 454 patients in the surgery group (Kaplan–Meier estimates, 22.8% in the TAVR group and 27.2% in the surgery group; difference, 4.3 percentage points; 95% confidence interval [CI], 9.9 to 1.3; P=0.07). The win ratio for the second primary end point was 1.17 (95% CI, 0.90 to 1.51; P=0.25). The Kaplan–Meier estimates for the components of the first primary end point were as follows: death, 10.0% in the TAVR group and 8.2% in the surgery group; stroke, 5.8% and 6.4%, respectively; and rehospitalization, 13.7% and 17.4%. The hemodynamic performance of the valve, assessed according to the mean (±SD) valve gradient, was 12.8±6.5 mm Hg in the TAVR group and 11.7±5.6 mm Hg in the surgery group. Bioprosthetic-valve failure occurred in 3.3% of the patients in the TAVR group and in 3.8% of those in the surgery group.

Conclusions

Among low-risk patients with severe, symptomatic aortic stenosis who underwent TAVR or surgery, there was no significant between-group difference in the two primary composite outcomes.

DOI: 10.1056/NEJMoa2307447

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2307447