• 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, Volkmar Falk, and DEDICATE-DZHK6 Trial Investigators.
• From the Department of Cardiology and the Center for Population Health Innovation, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf (S. Blankenberg, M.S., P.C., N.D., R.T., A.Z.), German Center for Cardiovascular Research (Deutsches Zentrum für Herz-Kreislauf-Forschung [DZHK]) partner site Hamburg-Kiel-Lübeck (S. Blankenberg, M.S., P.C., J.C., N.D., I.E., S.E., D.F., I.R.K., H.R., R.T.), and the Department of Cardiovascular Surgery, University Heart and Vascular Center Hamburg (H.R.), Hamburg, the Department of Cardiology and Angiology, BG University Hospital Bergmannsheil, Ruhr University Bochum, Bochum (M.S.), the Institute of Medical Biometry and Statistics, University of Lübeck (R.V., I.R.K.), the Departments of Cardiology, Angiology, and Intensive Care Medicine (I.E.) and Cardiovascular Surgery (S.E.), University Hospital of Schleswig-Holstein, Lübeck, the Department of Cardiology III-Adult Congenital and Valvular Heart Disease, University Hospital Münster, Müster (H.B.), the Departments of Thoracic and Cardiovascular Surgery (S. Bleiziffer) and General and Interventional Cardiology-Angiology (T.K.R.), Heart and Diabetes Center NRW, Ruhr University Bochum, Bad Oeynhausen, University Clinic of Cardiac Surgery (M.A.B.) and the Department of Internal Medicine (H.T.), Heart Center Leipzig at Leipzig University (M.A.B., H.T.), and Leipzig Heart Science (H.T.) and the Department of Cardiology at University Hospital Leipzig (A.H.), Leipzig, the Departments of Cardiac Surgery (Y.-H.C.) and Cardiology (W.-K.K.), Kerckhoff Clinic, Bad Nauheim, Medical Clinic I, the Department of Cardiology and Angiology, University of Giessen and Marburg (W.-K.K.), and Campus Kerckhoff and Medical Clinic I, University of Giessen (C. Hamm), Giessen, the Departments of Cardiovascular Surgery (J.C.) and Internal Medicine III (D.F.), University Hospital of Schleswig-Holstein, Kiel, Clinic for Cardiovascular Surgery, University Heart Center Freiburg-Bad Krozingen, University Clinic Freiburg, and the Faculty of Medicine, Albert Ludwigs University Freiburg (M.C.), and the Department of Cardiology and Angiology, University Heart Center Freiburg-Bad Krozingen, Faculty of Medicine, University of Freiburg (F.-J.N., D.W.), Freiburg, the Department of Cardiology, Angiology, and Pneumology, Heidelberg University Hospital (N.F.), DZHK partner site Heidelberg-Mannheim (N.F., M. Karck), and the Department of Cardiac Surgery, University Hospital Heidelberg (M. Karck), Heidelberg, the Departments of Cardiac Surgery (C. Hagl) and Cardiology (S.M.), University Hospital Munich, Ludwig Maximilians University Munich, DZHK partner site Munich Heart Alliance (C. Hagl, M. Krane, S.M., E.X.), and the Department of Cardiovascular Surgery, Institute Insure, German Heart Center Munich, School of Medicine and Health (M. Krane), and the Department of Cardiology, German Heart Center Munich, Technical University of Munich (E.X.), Munich, DZHK partner site Rhine-Main, Rhine-Main (C. Hamm, W.-K.K., T.W.), the Departments of Cardiac Surgery (U.K.) and Internal Medicine and Cardiology (A.L.), Heart Center Dresden, University of Technology Dresden, Dresden, the Departments of Cardiology, Angiology, and Intensive Care Medicine (U.L.) and Cardiothoracic and Vascular Surgery (V.F.), Deutsches Herzzentrum der Charité, Charité University Medicine Berlin (U.L., V.F.), and DZHK partner site Berlin (U.L., V.F.), Berlin, the Departments of Internal Medicine II (L.S.M.) and Cardiothoracic Surgery (C.S.), University Medical Center Regensburg, Regensburg, and the Department of Cardiac and Vascular Surgery, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt am Main (T.W.) - all in Germany; the Division of Cardiac Surgery, Department of Surgery, Yale School of Medicine, New Haven, CT (M. Krane); Cardio-CARE, Medizincampus Davos, Davos (A.Z., S. Blankenberg), and the Department of Health Sciences and Technology, ETH Zurich, Translational Cardiovascular Technology, Zurich (V.F.) - both in Switzerland; and the School of Mathematics, Statistics, and Computer Science, University of KwaZulu-Natal, Pietermaritzburg, South Africa (A.Z.).
• N. Engl. J. Med. 2024 May 2; 390 (17): 157215831572-1583.

BackgroundAmong 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.MethodsIn 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.ResultsA 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.ConclusionsAmong 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.).Copyright © 2024 Massachusetts Medical Society.

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