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ACC.24: TAVI Vs SAVR in Patients with Severe Aortic Valve Stenosis: DEDICATE-DZHK6
Published: 08 Apr 2024
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ACC.24 — Investigator Dr Moritz Seiffert (University Heart and Vascular Center Hamburg, DE) joins us onsite at ACC to discuss the findings of the DEDICATE-DZHK6 Trial (NCT03112980).
This randomized controlled, multi-center trial aimed to investigate whether transcatheter aortic valve implantation (TAVI) is non-inferior to surgical aortic valve replacement (SAVR) in patients with symptomatic severe aortic stenosis at low to intermediate operative risk of mortality, as measured by all-cause mortality or stroke at 1 and 5 years. 1414 patients were enrolled in this trial, and were randomized in a 1:1 fashion to receive either TAVI or SAVR.
Findings showed that, among patients with severe aortic stenosis at low or intermediate surgical risk, TAVI with prosthesis selection based on operator discretion was non-inferior to SAVR in regard to risk of death from any cause or stroke at 1 year.
Interview Questions:
- What is the importance of this study?
- What was the study design and patient population?
- What are the key findings?
- How should these findings impact clinical practice?
- What is the main take-home message?
- Where are the knowledge gaps?
Recorded remotely from Atlanta, 2024.
For more content from ACC.24 head to the Late-breaking Science Video Collection.
Support: This is an independent interview conducted by Radcliffe Cardiology.
Editors: Jordan Rance, Mirjam Boros
Video Specialists: Dan Brent, Tom Green, Mike Knight
"My name is Moritz Seiffert. I'm an interventional cardiologist and a professor of cardiology at Ruhr University in Bochum, Germany.
Overview of the DEDICATE Trial
The DEDICATE trial is essentially an all-comers trial comparing SAVR (Surgical Aortic Valve Replacement) and TAVI (Transcatheter Aortic Valve Implantation) in a low to intermediate risk population. Over 1400 patients were randomized to either SAVR or TAVI. Patients had to be low to intermediate risk and at least 65 years old.
Trial Design and Follow-up
The heart team was central to this trial, making decisions on eligibility, choice of device, and pre-procedural care according to the assigned treatment options. Patients were followed up to one year. The co-primary safety endpoint was all-cause death or stroke at one year, which was the primary outcome of this analysis. Patients will continue to be followed for an additional five years for the primary efficacy outcome of death or stroke at five years. At that point, if applicable, both non-inferiority and, potentially, superiority will be tested for the primary outcome.
Results
TAVI was found to be non-inferior to SAVR regarding the primary endpoint of all-cause death or stroke, with a hazard ratio of 4.53. Furthermore, some secondary endpoints and components of the primary outcome showed that the event rate for all-cause deaths was significantly lower in the TAVI arm compared to SAVR.
Clinical Implications
The clinical implications of the DEDICATE trial are significant. In addition to the evidence we have from the one-year timeframe, the trial provides a strong argument in favor of catheter-based treatment for these younger, low-risk patients, as opposed to previous trials. The DEDICATE trial is unique in that it is not sponsored by any specific device manufacturer but is funded by academic research institutions, allowing all devices to be considered. This aspect adds credibility, as it reflects clinical routine care as closely as possible.
Future Considerations
Particularly for this younger, low-risk patient population, long-term data will be essential. We will need to examine five-year and ten-year timeframes to draw final conclusions about whether TAVI or SAVR is more appropriate for this patient population. This ongoing trial will continue to provide important data.”
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