Transcatheter aortic valve implantation (TAVI) serves a growing spectrum of patients with
symptomatic severe aortic stenosis (AS). Approximately 80% of surgical aortic valve
replacements is performed using a bioprosthesis1. Durability of surgical bioprostheses
varies based on the patient's age at the moment of implantation, type and size etc2. TAVI
has become the preferred treatment for degenerated aortic bioprostheses in elderly
patients3. The median time since index surgical aortic valve replacement (SAVR) and for
bioprosthetic valve degeneration is typically 8 - 10 years4-6. TAVI in this setting has
proven to have equally favorable results as in native aortic valves7. Balloon expandable8
and self-expanding9 transcatheter heart valves (THV) can be used in a degenerated
bioprosthesis and each have specific assets and limitations. TAVI in a failed
bioprosthesis can cause coronary obstruction, THV migration, paravalvular leakage and
prosthesis patient mismatch. The SAPIEN-3 / Ultra and EVOLUT R/Pro are the 2 most
commonly used THV platforms in contemporary clinical practice including treatment of
failing surgical aortic bioprostheses.
Objective: To compare TAVI with EVOLUT R/Pro vs. SAPIEN-3 / Ultra in terms of device
success.
Study design: International multi-center randomized study with 1:1 randomization to TAVI
with SAPIEN-3 / Ultra or Evolut R/Pro.
Study population: 440 patients with a failing surgical aortic bioprosthesis (aortic
stenosis with or without aortic regurgitation) and selected for transfemoral TAVI by
heart-team consensus.
Investigational intervention: Transfemoral TAVI with SAPIEN-3 / Ultra or Evolut R/PRO
Main study parameters/endpoints:
1. Primary endpoint is device success at 30 days
Defined by
- Absence of procedural mortality AND
- Correct positioning of a single prosthetic heart valve into the proper
anatomical location AND
- Intended performance of the prosthetic heart valve (no severe prosthesis-
patient mismatch and mean aortic valve gradient < 20 mmHg or peak velocity < 3
m/s, AND no moderate or severe prosthetic valve regurgitation). Severe
prosthesis patient mismatch is defined by effective orifice area (EOAi) ≤0.65
cm2/m2
2. Safety endpoint at 1 year defined by the composite of all-cause death, disabling
stroke, rehospitalization for heart failure or valve related problems.
