Safety of TAVI non-inferior to SAVR in patients with lower surgical risk

Transcatheter aortic valve implantation (TAVI) in patients with low-to-intermediate surgical risk demonstrated non-inferiority to surgical aortic valve replacement (SAVR) in terms of safety after 1 year. The likelihood of death or stroke was 47% lower in the TAVI group compared with the SAVI group in the DEDICATE-DZHK6 trial.

The multicentre, randomised-controlled DEDICATE-DZHK6 study (NCT03112980) investigated TAVI compared with SAVR in 1,414 participants aged 65–85 years with low-to-intermediate surgical risk [1]. To reflect routine medical care, the study design allowed the use of any kind of contemporary devices. Over 55% of the participants were men and the mean age was about 74 years. The STS-PROM score, an operative risk calculator, was 1.8%, clearly indicating a low-risk cohort.

Prof. Moritz Seiffert (BG University Hospital Bergmannsheil, Germany) presented the results of the primary safety endpoint of all-cause death or stroke at 1 year. The primary efficacy endpoint will be evaluated at year 5 of the study. The present analysis tested for non-inferiority of TAVI versus SAVR with a rejectable absolute between-group difference of 1%.

The results of the co-primary endpoint of all-cause death or stroke at 12 months revealed a cumulative incidence rate of 5.4% in the TAVI group compared with 10% in the SAVR group, corresponding to a 47% lower outcome probability (HR 0.53; 95% CI 0.35–0.79) and a P<0.001 for non-inferiority of TAVI. Disparities in the singular components were also recognised between the TAVI and SAVR groups, leading to HR of 0.43 (95% CI 0.24–0.73) for death and HR 0.61 (95% CI 0.35–1.06) for stroke, respectively.

“In the DEDICATE trial, an investigator-initiated, independent trial designed to evaluate patients that mirror our daily clinical routine with aortic stenosis at low or intermediate surgical risk, TAVI with a prosthesis selection based on operator discretion was non-inferior to SAVR with respect to death from any cause or stroke at 1 year,” concluded Prof. Seiffert.

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   1. Seiffert M. Transcatheter aortic valve implantation vs. surgical aortic valve replacement in patients at low to intermediate risk- one-year outcomes of the randomised DEDICATE-DZHK6 trial. LB5, Session 412, ACC 2024 Scientific Session, 6–8 April, Atlanta, USA.

Medical writing support was provided by Karin Drooff, MPH.
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Posted on 10 April, 202410 April, 2024