Moritz Seiffert; Reinhard Vonthein; Helmut Baumgartner; Michael  A. Borger; Yeong-Hoon Choi; Volkmar Falk; Norbert Frey; Andreas Hagendorff; Christian Hagl; Christian Hamm; Inke  R. König; Ulf Landmesser; Steffen Massberg; Hermann Reichenspurner; Holger Thiele; Raphael Twerenbold; Maren Vens; Thomas Walther; Andreas Ziegler; Jochen Cremer; Stefan Blankenberg

doi:10.4244/EIJ-D-23-00232

The Official Journal of EuroPCR and the European Association of Percutaneous Cardiovascular Interventions (EAPCI)

The reference multimedia journal in interventional cardiology

Trial design

DOI: 10.4244/EIJ-D-23-00232

Transcatheter aortic valve implantation versus surgical aortic valve replacement in patients at low to intermediate surgical risk: rationale and design of the randomised DEDICATE Trial

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

Abstract

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...

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