本文由小咖机器人翻译整理

期刊来源：N Engl J Med

原文链接：https://doi.org/10.1056/NEJMoa2400685

摘要内容如下：

背景

在符合经导管主动脉瓣植入术（TAVI）和外科主动脉瓣置换术（Savr）的严重症状性主动脉瓣狭窄的低风险患者中，缺乏常规临床实践中适当治疗策略的数据。

方法

在这项在德国38个地点进行的随机非劣效性试验中，我们将低或中等手术风险的严重主动脉瓣狭窄患者分为TAVI或Savr两组。根据操作者的判断选择经皮和外科瓣膜假体。主要终点是1年内任何原因导致的死亡或致死性或非致死性卒中的复合终点。

结果

共有1414名患者接受了随机分组（701名进入TAVI组，713名进入Savr组）。患者的平均（±SD）年龄为74±4岁；57%为男性，胸外科医师协会风险评分中位数为1.8%（低手术风险）。1年时主要转归的Kaplan-Meier估计值在TAVI组中为5.4%，在Savr组中为10.0%（死亡或卒中的风险比为0.53；95%置信区间[CI]，0.35至0.79；非劣效性P<0.001）。任何原因的死亡发生率在TAVI组中为2.6%，在Savr组中为6.2%（风险比为0.43；95%可信区间为0.24~0.73）；中风的发生率分别为2.9%和4.7%（风险比为0.61；95%置信区间为0.35至1.06）。TAVI和SAVR组的手术并发症发生率分别为1.5%和1.0%。

结论

在低度或中度手术风险的严重主动脉瓣狭窄患者中，TAVI在1年内任何原因死亡或卒中方面均不劣于Savr。（由德国心血管研究中心（German Center for Cardiovascular Research）和德国心脏基金会（German Heart Foundation）资助；Dedicated-DZHK6 ClinicalTrials.gov number，NCT03112980）。

英文原文如下：

Abstracts

BACKGROUND  Among low-risk patients with severe, symptomatic aortic stenosis who are eligible for both transcatheter aortic-valve implantation (TAVI) and surgical aortic-valve replacement (SAVR), data are lacking on the appropriate treatment strategy in routine clinical practice.

METHODS  In this randomized noninferiority trial conducted at 38 sites in Germany, we assigned patients with severe aortic stenosis who were at low or intermediate surgical risk to undergo either TAVI or SAVR. Percutaneous- and surgical-valve prostheses were selected according to operator discretion. The primary outcome was a composite of death from any cause or fatal or nonfatal stroke at 1 year.

RESULTS  A total of 1414 patients underwent randomization (701 to the TAVI group and 713 to the SAVR group). The mean (±SD) age of the patients was 74±4 years; 57% were men, and the median Society of Thoracic Surgeons risk score was 1.8% (low surgical risk). The Kaplan-Meier estimate of the primary outcome at 1 year was 5.4% in the TAVI group and 10.0% in the SAVR group (hazard ratio for death or stroke, 0.53; 95% confidence interval [CI], 0.35 to 0.79; P<0.001 for noninferiority). The incidence of death from any cause was 2.6% in the TAVI group and 6.2% in the SAVR group (hazard ratio, 0.43; 95% CI, 0.24 to 0.73); the incidence of stroke was 2.9% and 4.7%, respectively (hazard ratio, 0.61; 95% CI, 0.35 to 1.06). Procedural complications occurred in 1.5% and 1.0% of patients in the TAVI and SAVR groups, respectively.

CONCLUSIONS  Among patients with severe aortic stenosis at low or intermediate surgical risk, TAVI was noninferior to SAVR with respect to death from any cause or stroke at 1 year. (Funded by the German Center for Cardiovascular Research and the German Heart Foundation; DEDICATE-DZHK6 ClinicalTrials.gov number, NCT03112980.).

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