Safety of TAVI non-inferior to SAVR for 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, according to the results of the DEDICATE-DZHK6 trial.             

“TAVI has become the preferred treatment option for most patients with symptomatic severe aortic valve stenosis. Current evidence for young, low-risk patients, however, remains restricted to device-specific and industry-sponsored trials and that’s potentially limiting the applicability to routine practice,” Prof. Moritz Seiffert (BG University Hospital Bergmannsheil, Germany) explained the motivation for the DEDICATE-DZHK6 study (NCT03112980) [1].

This investigator-initiated, multicentre, randomised-controlled trial strove to reflect routine medical care by allowing the use of any kind of contemporary devices per design. It compared TAVI with SAVR in 1,414 participants aged 65–85 years with low-to-intermediate surgical risk. Over 55% of the participants were men and the mean age was about 74 years. The STS-PROM score, a surgical risk calculator, was 1.8% and 1.9% in the 2 study groups, indicating a low-risk cohort.

Prof. Seiffert 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 (see Figure). Results for TAVI versus SAVR were consistent for the individual components of the primary endpoint including an 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.

Figure: DEDICATE-DZHK6 primary safety endpoint: all-cause death or stroke a 1 year [1]



CI, confidence interval; HR, hazard ratio; SAVR, surgical aortic valve replacement; TAVI, transcatheter aortic valve implantation.

“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.

1. Seiffert M, et al. 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.

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Posted on 16 May 202413 June 2024