Transcatheter or Surgical Treatment of Aortic-Valve Stenosis

被引：15

作者：

Blankenberg, Stefan ^{[1
,2
,3
,45
]}

Seiffert, Moritz ^{[1
,2
,3
,5
]}

Vonthein, Reinhard ^{[6
]}

Baumgartner, Helmut ^{[9
]}

Bleiziffer, Sabine ^{[10
]}

Borger, Michael A. ^{[12
,14
]}

Choi, Yeong-Hoon ^{[17
]}

Clemmensen, Peter ^{[1
,2
,3
]}

Cremer, Jochen ^{[3
,21
]}

Czerny, Martin ^{[23
,24
]}

Diercks, Nina ^{[1
,2
,3
]}

Eitel, Ingo ^{[3
,7
]}

Ensminger, Stephan ^{[3
,8
]}

Frank, Derk ^{[3
,22
]}

Frey, Norbert ^{[26
,27
]}

Hagendorff, Andreas ^{[16
]}

Hagl, Christian ^{[29
,31
]}

Hamm, Christian ^{[20
,34
]}

Kappert, Utz ^{[35
]}

Karck, Matthias ^{[27
,28
]}

Kim, Won-Keun ^{[18
,19
,34
]}

Koenig, Inke R. ^{[3
,6
]}

Krane, Markus ^{[31
,32
,44
]}

Landmesser, Ulf ^{[37
,39
,40
]}

Linke, Axel ^{[36
]}

Maier, Lars S. ^{[41
]}

Massberg, Steffen ^{[30
,31
]}

Neumann, Franz-Josef ^{[25
]}

Reichenspurner, Hermann ^{[3
,4
]}

Rudolph, Tanja K. ^{[11
]}

Schmid, Christof ^{[42
]}

Thiele, Holger ^{[13
,14
,15
]}

Twerenbold, Raphael ^{[1
,2
,3
]}

Walther, Thomas ^{[34
,43
]}

Westermann, Dirk ^{[25
]}

Xhepa, Erion ^{[31
,33
]}

Ziegler, Andreas ^{[1
,2
,45
,47
]}

Falk, Volkmar ^{[38
,39
,40
,46
]}

机构：

[1] Univ Med Ctr Hamburg Eppendorf, Dept Cardiol, Hamburg, Germany

[2] Univ Med Ctr Hamburg Eppendorf, Univ Heart & Vasc Ctr Hamburg, Ctr Populat Hlth Innovat, Hamburg, Germany

[3] German Ctr Cardiovasc Res, Deutsch Zent Herz Kreislauf Forsch DZHK, Partner Site Hamburg Kiel Lubeck, Hamburg, Germany

[4] Univ Heart & Vasc Ctr Hamburg, Dept Cardiovasc Surg, Hamburg, Germany

[5] Ruhr Univ Bochum, BG Univ Hosp Bergmannsheil, Dept Cardiol & Angiol, Bochum, Germany

[6] Univ Lubeck, Inst Med Biometry & Stat, Lubeck, Germany

[7] Univ Hosp Schleswig Holstein, Dept Cardiol Angiol & Intens Care Med, Lubeck, Germany

[8] Univ Hosp Schleswig Holstein, Dept Cardiovasc Surg, Lubeck, Germany

[9] Univ Hosp Munster, Dept Cardiol Adult Congenital & Valvular Heart Di, Muster, Germany

[10] Ruhr Univ Bochum, Heart & Diabet Ctr NRW, Dept Thorac & Cardiovasc Surg, Bad Oeynhausen, Germany

[11] Ruhr Univ Bochum, Heart & Diabet Ctr NRW, Dept Gen & Intervent Cardiol Angiol, Bad Oeynhausen, Germany

[12] Univ Leipzig, Univ Clin Cardiac Surg, Heart Ctr Leipzig, Leipzig, Germany

[13] Univ Leipzig, Dept Internal Med, Heart Ctr Leipzig, Leipzig, Germany

[14] Univ Leipzig, Heart Ctr Leipzig, Leipzig, Germany

[15] Leipzig Heart Sci, Leipzig, Germany

[16] Univ Hosp Leipzig, Dept Cardiol, Leipzig, Germany

[17] Kerckhoff Clin, Dept Cardiac Surg, Bad Nauheim, Germany

[18] Kerckhoff Clin, Dept Cardiol, Bad Nauheim, Germany

[19] Univ Giessen & Marburg, Dept Cardiol & Angiol, Med Clin 1, Giessen, Germany

[20] Univ Giessen, Campus Kerckhoff & Med Clin 1, Giessen, Germany

[21] Univ Hosp Schleswig Holstein, Dept Cardiovasc Surg, Kiel, Germany

[22] Univ Hosp Schleswig Holstein, Dept Internal Med 3, Kiel, Germany

[23] Univ Clin Freiburg, Univ Heart Ctr Freiburg Bad Krozingen, Clin Cardiovasc Surg, Freiburg, Germany

[24] Albert Ludwigs Univ Freiburg, Fac Med, Freiburg, Germany

[25] Univ Freiburg, Univ Heart Ctr Freiburg Bad Krozingen, Fac Med, Dept Cardiol & Angiol, Freiburg, Germany

[26] Heidelberg Univ Hosp, Dept Cardiol Angiol & Pneumol, Heidelberg, Germany

[27] DZHK Partner Site Heidelberg Mannheim, Heidelberg, Germany

[28] Univ Hosp Heidelberg, Dept Cardiac Surg, Heidelberg, Germany

[29] Ludwig Maximilians Univ Munchen, Univ Hosp Munich, Dept Cardiac Surg, Munich, Germany

[30] Ludwig Maximilians Univ Munchen, Univ Hosp Munich, Dept Cardiol, Munich, Germany

[31] DZHK Partner Site Munich Heart Alliance, Munich, Germany

[32] German Heart Ctr Munich, Inst Insure, Sch Med & Hlth, Dept Cardiovasc Surg, Munich, Germany

[33] Tech Univ Munich, German Heart Ctr Munich, Dept Cardiol, Munich, Germany

[34] DZHK Partner Site Rhine Main, Rhine Main, Germany

[35] Univ Technol Dresden, Heart Ctr Dresden, Dept Cardiac Surg, Dresden, Germany

[36] Univ Technol Dresden, Heart Ctr Dresden, Dept Internal Med & Cardiol, Dresden, Germany

[37] Charite Univ Med Berlin, Dept Cardiol Angiol & Intens Care Med, Berlin, Germany

[38] Charite Univ Med Berlin, Dept Cardiothorac & Vasc Surg, Berlin, Germany

[39] Charite Univ Med Berlin, Deutsch Herzzentrum Charite, Berlin, Germany

[40] DZHK Partner Site Berlin, Berlin, Germany

[41] Univ Med Ctr Regensburg, Dept Internal Med 2, Regensburg, Germany

[42] Univ Med Ctr Regensburg, Dept Cardiothorac Surg, Regensburg, Germany

[43] Goethe Univ Frankfurt, Univ Hosp Frankfurt, Dept Cardiac & Vasc Surg, Frankfurt, Germany

[44] Yale Sch Med, Dept Surg, Div Cardiac Surg, New Haven, CT USA

[45] Medizincampus Davos, Cardio CARE, Davos, Switzerland

[46] Swiss Fed Inst Technol, Dept Hlth Sci & Technol, Translat Cardiovasc Technol, Zurich, Switzerland

[47] Univ KwaZulu Natal, Sch Math Stat & Comp Sci, Pietermaritzburg, South Africa

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2024年 / 390卷 / 17期

关键词：

END-POINT DEFINITIONS; REPLACEMENT; OUTCOMES;

D O I：

10.1056/NEJMoa2400685

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.)

引用

页码：1572 / 1583

页数：12

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