Moritz Seiffert1,2,3, MD; Reinhard Vonthein4, PhD; Helmut Baumgartner5, MD; Michael A. Borger6, MD, PhD; Yeong-Hoon Choi7,8, MD; Volkmar Falk9,10,11, MD; Norbert Frey12,13, MD; Andreas Hagendorff14, MD; Christian Hagl15,16, MD; Christian Hamm8,17, MD; Inke R. König3,4, PhD; Ulf Landmesser10,18, MD; Steffen Massberg15,19, MD; Hermann Reichenspurner3,20, MD, PhD; Holger Thiele21, MD; Raphael Twerenbold1,2,3, MD; Maren Vens4, PhD; Thomas Walther8,22, MD; Andreas Ziegler1,2,23,24, PhD; Jochen Cremer3,25, MD; Stefan Blankenberg1,2,3, MD
1. Department of Cardiology, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; 2. Centre for Population Health Innovation (POINT), University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; 3. DZHK (German Centre for Cardiovascular Research) partner site Hamburg/Kiel/Lübeck, Hamburg, Germany; 4. Institute of Medical Biometry and Statistics, University of Lübeck, Lübeck, Germany; 5. Department of Cardiology III - Adult Congenital and Valvular Heart Disease, University Hospital Muenster, Muenster, Germany; 6. Department of Cardiac Surgery, Heart Center Leipzig at University of Leipzig, Leipzig, Germany; 7. Department of Cardiac Surgery, Kerckhoff-Klinik, Bad Nauheim, Germany; 8. DZHK (German Centre for Cardiovascular Research) partner site Rhine-Main, Rhine-Main, Germany; 9. Department of Cardiothoracic and Vascular Surgery, Deutsches Herzzentrum der Charité (DHZC), Berlin, Germany; 10. DZHK (German Centre for Cardiovascular Research) partner site Berlin, Berlin, Germany; 11. Department of Health Sciences & Technology, ETH Zurich, Translational Cardiovascular Technology, Zurich, Switzerland; 12. Department of Cardiology, Angiology, and Pneumology, Heidelberg University Hospital, Heidelberg, Germany; 13. DZHK (German Centre for Cardiovascular Research) partner site Heidelberg/Mannheim, Heidelberg, Germany; 14. Department of Cardiology, University of Leipzig, Leipzig, Germany; 15. Department of Cardiac Surgery, University Hospital Munich, Ludwig-Maximilians-University Munich, Munich, Germany; 16. DZHK (German Centre for Cardiovascular Research) partner site Munich Heart Alliance, Munich, Germany; 17. Campus Kerckhoff and Medical Clinic I, University of Giessen, Giessen, Germany; 18. Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité (DHZC), Berlin, Germany and Charité Universitätsmedizin Berlin, Berlin, Germany; 19. Department of Cardiology, University Hospital Munich, Ludwig-Maximilians-University Munich, Munich, Germany; 20. Department of Cardiovascular Surgery, University Heart and Vascular Center Hamburg, Hamburg, Germany; 21. Department of Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany and Leipzig Heart Science, Leipzig, Germany; 22. Department of Thoracic and Cardiovascular Surgery, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt am Main, Germany; 23. Cardio-CARE, Medizincampus Davos, Davos, Switzerland; 24. School of Mathematics, Statistics and Computer Science, University of KwaZulu-Natal, Pietermaritzburg, South Africa; 25. Department of Cardiovascular Surgery, University Hospital of Schleswig-Holstein, Kiel, Germany
Transcatheter aortic valve implantation (TAVI) has become the preferred treatment option for patients with severe aortic stenosis at increased risk for surgical aortic valve replacement (SAVR) and for older patients irrespective of risk. However, in younger, low-risk patients for whom both therapeutic options, TAVI and SAVR, are applicable, the optimal treatment strategy remains controversial, as data on long-term outcomes remain limited. The DEDICATE-DZHK6 Trial is an investigator-initiated, industry-independent, prospective, multicentre, randomised controlled trial investigating the efficacy and safety of TAVI compared to SAVR in low- to intermediate-risk patients aged 65 years or older. To evaluate both treatment strategies, approximately 1,404 patients determined eligible for both TAVI and SAVR by the interdisciplinary Heart Team were randomised to TAVI or SAVR. Broad inclusion and strict exclusion criteria targeted an all-comers patient population. Procedures were performed according to local best practice with contemporary routine medical devices. The primary endpoints are a composite of mortality or stroke at 1 year and 5 years in order to incorporate midterm efficacy results and complement early safety data. Primary outcomes will be tested sequentially for non-inferiority and superiority. The DEDICATE-DZHK6 Trial has been designed to mirror clinical reality for the treatment of severe aortic stenosis and provide unique information on overall outcomes after TAVI and SAVR that can be directly applied to clinical routines. Its results will help further define optimal treatment strategies for low- to intermediate-risk patients in whom both TAVI and SAVR are currently advisable.
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