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Transcatheter or Surgical Treatment of Aortic Valve Stenosis

  • May 29, 2024

Submitted by: Mateo Marin-Cuartas

Source: The New England Journal of Medicine
Source URL: https://www.nejm.org/doi/full/10.1056/NEJMoa2400685

Keywords:

  • Cardiac
Author(s): Stefan Blankenberg, Moritz Seiffert, Reinhard Vonthein, Helmut Baumgartner, Sabine Bleiziffer, Michael A. Borger, Yeong-Hoon Choi, Peter Clemmensen, Jochen Cremer, Martin Czerny, Nina Diercks, Ingo Eitel, Stephan Ensminger, Derk Frank, Norbert Frey, Andreas Hagendorff, Christian Hagl, Christian Hamm, Utz Kappert, Matthias Karck, Won-Keun Kim, Inke R. König, Markus Krane, Ulf Landmesser, Axel Linke, Lars S. Maier, Steffen Massberg, Franz-Josef Neumann, Hermann Reichenspurner, Tanja K. Rudolph, Christof Schmid, Holger Thiele, Raphael Twerenbold, Thomas Walther, Dirk Westermann, Erion Xhepa, Andreas Ziegler, and Volkmar Falk

The DEDICATE-DZHK6 is a non-industry sponsored randomized noninferiority trial conducted at 38 sites in Germany, where patients with severe aortic stenosis who were at low or intermediate surgical risk were randomly assigned to undergo either transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR). TAVI and SAVR prostheses were selected at the operator’s discretion. The primary outcome was a composite of death from any cause or fatal or nonfatal stroke at one year. A total of 1,414 patients underwent randomization, 701 to the TAVI group and 713 to the SAVR group). The mean age was 74±4 years, 57 percent were men, and the median Society of Thoracic Surgeons risk score was 1.8 percent. The Kaplan–Meier estimate of the primary outcome at one year was 5.4 percent in the TAVI group and 10 percent in the SAVR group (hazard ratio (HR) for death or stroke, 0.53; 95 percent confidence interval [CI], 0.35 to 0.79; P

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