1-Year Outcomes of Novel Balloon-Expandable vs Contemporary Transcatheter Heart Valves in Severe Aortic Stenosis: The LANDMARK Trial.

The current report from the LANDMARK trial describes clinical outcomes, hemodynamic performances, and quality of life at 1 year.

LANDMARK试验的当前报告描述了1年时的临床结果、血流动力学表现和生活质量。

Methods

This open-label, noninferiority trial enrolled 768 participants across 31 hospitals in Europe, New Zealand, and Brazil.

这项开放标签、非劣效试验在欧洲、新西兰和巴西的31家医院共招募了768名参与者。

Participants were randomly assigned (1:1) to receive either a Myval THV series or a contemporary THV (SAPIEN or Evolut series).

参与者被随机分配（1:1），接受Myval THV系列或当代THV（SAPIEN或Evolut系列）治疗。

The composite endpoint at 1 year included all-cause mortality, all strokes, and procedure- or valve-related hospitalizations.

1年时的复合终点包括全因死亡、所有中风以及与程序或瓣膜相关的住院。

Clinical efficacy was defined as freedom from the composite endpoint.

临床疗效被定义为无复合终点事件。

As recommended in Valve Academic Research Consortium-3, the previous composite endpoint combined with the assessment of quality of life at baseline and 1 year with the 12-Item Short Form Health Survey was reported as an extended composite endpoint.

如Valve Academic Research Consortium-3所推荐的，先前的复合终点结合了基线和1年时使用12项简短健康调查问卷评估的生活质量，被报告为扩展的复合终点。

The noninferiority hypothesis was prespecified for the assessment of the primary endpoint at 30 days.

在30天主要终点评估中，预先设定了非劣效性假设。

Considering the specific 1-year composite endpoints of Valve Academic Research Consortium-3 and the event rate of 27.23% derived from recent studies, an a posteriori descriptive and exploratory noninferiority hypothesis was introduced with a noninferiority margin of 10.89%.

考虑到Valve Academic Research Consortium-3定义的特定1年复合终点和来自近期研究的事件发生率为27.23%，引入了一个事后描述性和探索性的非劣效假设，非劣效边界设定为10.89%。

The analysis was performed in the intention-to-treatpopulation.

分析是在意向治疗人群中进行的。

Results

The mean age was 80 years, 48% were women, and the median Society of Thoracic Surgeons Predicted Risk of Mortality score was 2.6%.

平均年龄为80岁，48%为女性，中位数的胸外科医生预测死亡风险评分为2.6%。

There was no significant difference in the Kaplan-Meier estimates of freedom from the composite endpoint at 365 days (Myval THV 87.0% vs contemporary THVs 86.9%).

在365天时，Myval THV与当代THVs在复合终点无显著差异的Kaplan-Meier估计自由度（Myval THV 87.0% vs 当代THVs 86.9%）。

The Myval THV series was noninferior to the contemporary THVs for the composite endpoint (difference: -0.1%; 1-sided 95% CI: 3.9%; Pnoninferiority < 0.0001).

Myval THV系列在复合终点上与当代THVs相比显示出非劣效性（差异：-0.1%；单侧95%置信区间：3.9%；非劣效性P值<0.0001）。

Similarly, there were no significant differences in freedom from the extended composite endpoint (80.5% vs 77.3%; difference: 3.2%; 95% CI: -2.9% to 9.2%; P = 0.33).

同样，在扩展复合终点的自由度上没有显著差异（80.5%对比77.3%；差异：3.2%；95%置信区间：-2.9%至9.2%；P=0.33）。

Conclusions

In the treatment of symptomatic severe native aortic stenosis, the clinical and hemodynamic outcomes of the Myval THV series were comparable to those of contemporary THVs for the 1-year composite of all-cause mortality, all strokes, or procedure- or valve-related hospitalizations.

在有症状的严重原发性主动脉瓣狭窄治疗中，Myval THV系列的临床和血流动力学结果与当前经导管心脏瓣膜（THVs）在1年内全因死亡率、所有中风或与手术或瓣膜相关的住院率的综合结果相当。

(LANDMARK Trial: a Randomised Controlled Trialof Myval THV [LANDMARK]; NCT04275726).

（LANDMARK试验：一项Myval THV的随机对照试验[LANDMARK]; NCT04275726）。