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DEDICATE trial shows transcatheter aortic valve implantation in patients with low-to-intermediate risk is not inferior to surgical aortic valve replacement.
Transcatheter aortic valve implantation (TAVI) in patients with low-to-intermediate surgical risk demonstrated noninferiority 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 trial.
The multicenter, randomized-controlled DEDICATE study (NCT03112980) investigated TAVI compared with SAVR in 1,414 participants aged 65–85 with low-to-intermediate surgical risk.1 To reflect routine medical care, the study design allowed the use of any kind of contemporary device. 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.
Moritz Seiffert, MD, 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 recognized between the TAVI and SAVR groups, leading to HR of 0.43 (95% CI, 0.24–0.73) for death and HR of 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 Dr. Seiffert.
Medical writing support was provided by Karin Drooff, MPH.
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