Transcatheter or Surgical Treatment of Aortic-Valve Stenosis

Blankenberg, Stefan and Seiffert, Moritz and Vonthein, Reinhard and Baumgartner, Helmut and Bleiziffer, Sabine and Borger, Michael A. and Choi, Yeong-Hoon and Clemmensen, Peter and Cremer, Jochen and Czerny, Martin and Diercks, Nina and Eitel, Ingo and Ensminger, Stephan and Frank, Derk and Frey, Norbert and Hagendorff, Andreas and Hagl, Christian and Hamm, Christian and Kappert, Utz and Karck, Matthias and Kim, Won-Keun and Koenig, Inke R. and Krane, Markus and Landmesser, Ulf and Linke, Axel and Maier, Lars S. and Massberg, Steffen and Neumann, Franz-Josef and Reichenspurner, Hermann and Rudolph, Tanja K. and Schmid, Christof and Thiele, Holger and Twerenbold, Raphael and Walther, Thomas and Westermann, Dirk and Xhepa, Erion and Ziegler, Andreas and Falk, Volkmar (2024) Transcatheter or Surgical Treatment of Aortic-Valve Stenosis. NEW ENGLAND JOURNAL OF MEDICINE, 390 (17). pp. 1572-1583. ISSN 0028-4793, 1533-4406

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Abstract

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.)

Item Type:	Article
Uncontrolled Keywords:	END-POINT DEFINITIONS; REPLACEMENT; OUTCOMES;
Subjects:	600 Technology > 610 Medical sciences Medicine
Divisions:	Medicine > Lehrstuhl für Herz-, Thorax- und herznahe Gefäßchirurgie Medicine > Lehrstuhl für Innere Medizin II
Depositing User:	Dr. Gernot Deinzer
Date Deposited:	18 Aug 2025 08:52
Last Modified:	18 Aug 2025 08:52
URI:	https://pred.uni-regensburg.de/id/eprint/65621

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