- Question
- Is the Myval transcatheter valve series, with sizes increasing in 1.5 mm steps, non-inferior to contemporary transcatheter valves (Sapien or Evolut) in patients with severe symptomatic aortic stenosis?
- Design
- Prospective, multinational, randomised 1:1, open-label, non-inferiority trial across 31 hospitals in 16 countries, enrolling 768 participants. Analysis was by intention to treat.
- Population
- Patients with severe symptomatic native aortic stenosis deemed suitable for TAVI by the heart team according to 2021 ESC guidelines. Mean age was about 80 years and median STS score was 2.6% in both groups.
- Intervention
- Implantation of the balloon-expandable Myval transcatheter heart valve series, whose diameter increases in 1.5 mm increments (384 patients).
- Control
- Implantation of a contemporary valve: the Sapien series (Edwards) or the Evolut series (Medtronic) (384 patients).
- Primary outcome
- A 30-day composite, per VARC-3 criteria, of all-cause mortality, stroke, bleeding (types 3 and 4), acute kidney injury (stages 2-4), major vascular complications, moderate or severe prosthetic valve regurgitation, and conduction disturbances requiring a permanent pacemaker.
- Results
- The primary endpoint occurred in 25% with Myval and 27% with contemporary valves, a risk difference of -2.3% (one-sided upper 95% CI 3.8; non-inferiority p<0.0001), meeting the non-inferiority criterion. No significant differences were seen in the individual components of the composite.
- Conclusion
- At 30 days, the Myval valve was non-inferior to contemporary transcatheter valves on the primary composite endpoint.
- Why it matters
- It provided randomised evidence supporting Myval as an alternative to established platforms, broadening valve options and allowing finer size matching to the aortic annulus. The 30-day follow-up limits conclusions about durability.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026