The COMPARE TAVI organization conducted direct comparison of new transcatheter aortic valve implantation (TAVI) devices against contemporary best practices. To that end, it conducted a study that included an all-comers population (that is with no strict exclusion) to assess short-term safety and long-term durability, and to extrapolate data representative of the general population.
The analyzed cohort involved TAVI procedures using balloon-expandable valves: Sapien (Sapien 3 and Sapien 3 Ultra) versus Myval (Myval and Myval Octacor). Selected patients underwent transfemoral access, and procedures were performed in accredited centers with a minimum of ≥75 implantation procedures annually by experienced operators.
The primary endpoint (PEP) was a composite of death, stroke, moderate/severe aortic regurgitation, and moderate/severe valve deterioration at one year. Upon demonstrating non-inferiority between devices, TAVI-related complications, implant success, and need for permanent pacemaker (PPM) implantation were evaluated.
The study included a total of 1031 patients from three high-volume centers in Denmark (750 TAVI procedures annually). The average age was 81.1 years; 40% of subjects were women, and 79% had an STS score <4.
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In the balloon-expandable valve analysis, the Sapien group had a 13% incidence of the PEP, compared to 13.6% in the Myval group, with a risk difference of -0.9% (p=0.02), confirming non-inferiority between both groups after one year of follow-up.
An analysis of individual PEP components showed a higher trend towards moderate/severe aortic regurgitation and increased PPM implantation in the Myval group. Regarding secondary endpoints, the Sapien group had a higher incidence of moderate to severe prosthesis-patient mismatch.
Authors’ conclusion: Myval was non-inferior to Sapien concerning the evaluated PEP.
Presented by Henrik Nissen at Top Late-Breaking Trials, PCR London Valves, November 24, 2024, London, Great Britain.
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