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 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.
| Original language | English |
|---|---|
| Journal | EuroIntervention |
| Volume | 19 |
| Issue number | 8 |
| Pages (from-to) | 652-658 |
| Number of pages | 7 |
| ISSN | 1774-024X |
| DOIs | |
| Publication status | Published - 10.2023 |
Funding
The trial will be financed through a grant provided by the Deutsches Zentrum für Herz-Kreislauf-Forschung e.V. and with financial support from the Deutsche Herzstiftung e.V.. Study centers will be reimbursed according to randomized treatment by the health insurance companies, similar to standard clinical care. For the general risk of the disease itself and the performed treatment, the individual patients are covered by the hospital liability insurance. As described above, the study is performed according to current standard clinical treatment. The study-specific procedures solely include non-invasive examinations (e.g. questionnaires) and do not expose the patients to any significant additional risks. In addition, this study is not considered a clinical trial according to the definition of the “Medizinproduktegesetz”. Hence, no additional study-specific insurance is required. DEDICATE-DZHK6 is an investigator-initiated trial. Funding is provided exclusively by the DZHK (German Centre for Cardiovascular Research, funding code: 81X1710106) and the German Heart Foundation (Deutsche Herzstiftung e.V., Frankfurt am Main), assuring the independence of the trial.
DFG Research Classification Scheme
- 2.22-25 General and Visceral Surgery
