SAPIEN 3 versus Myval transcatheter heart valves for transcatheter aortic valve implantation (COMPARE-TAVI 1): a multicentre, randomised, non-inferiority trial.

Summary

In this all-comers Danish RCT (n=1031), the 1-year composite of death, stroke, moderate/severe aortic regurgitation, or moderate/severe hemodynamic THV deterioration was 13% with SAPIEN 3 vs 14% with Myval, meeting the prespecified non-inferiority margin. Findings support Myval as a clinically comparable alternative to SAPIEN 3 for transfemoral TAVI.

Key Findings

• Primary composite endpoint at 1 year: 13% (SAPIEN 3) vs 14% (Myval); risk difference −0.9% (one-sided upper 95% CI 4.4%), meeting non-inferiority.
• All-comers, multicenter randomized design with 1031 patients (median age 81.6 years; 40% women).
• Third VARC criteria used; intention-to-treat and per-protocol analyses planned.

Clinical Implications

Centers can consider Myval as a non-inferior alternative to SAPIEN 3 for transfemoral TAVI. Adoption may be guided by patient-specific anatomy, operator experience, availability, and cost without compromising 1-year composite outcomes.

Limitations

• The abstract does not report individual component outcomes or longer-term durability beyond 1 year.
• Enrollment pauses due to legal proceedings could introduce operational variability; generalizability outside Denmark requires caution.

Future Directions

Report device-specific secondary outcomes (e.g., pacemaker implantation, gradients, leaflet thrombosis) and extend follow-up for durability and structural valve deterioration. Cost-effectiveness analyses across health systems would inform procurement.