主动脉瓣狭窄的经导管或外科治疗

Transcatheter or Surgical Treatment of Aortic-Valve Stenosis

(The New England Journal of Medicine, IF:158.50)

• S. Blankenberg, M. Seiffert, R. Vonthein, H. Baumgartner, S. Bleiziffer, M.A. Borger, Y.-H. Choi, P. Clemmensen, J. Cremer, M. Czerny, N. Diercks, I. Eitel, S. Ensminger, D. Frank, N. Frey, A. Hagendorff, C. Hagl, C. Hamm, U. Kappert, M. Karck, W.-K. Kim, I.R. König, M. Krane, U. Landmesser, A. Linke, L.S. Maier, S. Massberg, F.-J. Neumann, H. Reichenspurner, T.K. Rudolph, C. Schmid, H. Thiele, R. Twerenbold, T. Walther, D. Westermann, E. Xhepa, A. Ziegler, and V. Falk, for the DEDICATE-DZHK6 Trial Investigators
• CORRESPONDENCE TO: [email protected]

BACKGROUND 背景

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.

症状严重的主动脉瓣狭窄的低风险患者，他们既适合经导管主动脉瓣植入术（TAVI）又适合外科主动脉瓣置换术（SAVR），但在常规临床实践中缺乏选择合适治疗策略的数据。

METHODS 方法

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.

在德国38个地点进行的这项随机非劣效性试验中，我们将手术风险低或中等的严重主动脉瓣狭窄患者分配接受TAVI或SAVR。经皮和外科瓣膜假体根据手术医生的判断进行选择。主要结局是1年内因任何原因导致的死亡或致死性或非致死性卒中的复合结果。

RESULTS 结果

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.

共有1414名患者接受了随机分组（701名患者被分配到TAVI组，713名患者被分配到SAVR组）。患者的平均年龄（±SD）为74±4岁；57%为男性，胸外科医师协会的中位风险评分为1.8%（手术风险低）。Kaplan–Meier估计，1年时TAVI组的主要结局比例为5.4%，SAVR组主要结局比例为10.0%（死亡或卒中的风险比为0.53；95%置信区间[CI]为0.35至0.79；非劣效性P<0.001）。TAVI组任何原因导致的死亡发生率为2.6%，SAVR组为6.2%（风险比为0.43；95%置信区间[CI]为0.24至0.73）；卒中的发生率分别为2.9%和4.7%（风险比为0.61；95%置信区间[CI]为0.35至1.06）。TAVI组和SAVR组分别有1.5%和1.0%的患者发生手术并发症。

CONCLUSIONS 结论

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.)

在低或中等手术风险的严重主动脉瓣狭窄患者中，1年内的因任何原因死亡或中风方面，TAVI不劣于SAVR。（由德国心血管研究中心和德国心脏基金会资助；DEDICATE-ZHK6 ClinicalTrials.gov编号，NCT03112980。）