TCT 2020 | Surprising Differences in Stroke between SAPIEN 3 and Evolut R

One-year outcomes of the head to head trial between CoreValve Evolut R vs Sapien 3 showed a significantly higher difference in stroke vs. patients receiving the self-expanding valve (Sapien 3 6.9% vs Evolut R 1%; p=0.002).

The SOLVE-TAVI randomized 2×2 patients with severe aortic stenosis and high surgical risk to Sapien 3 or Evolut R and general anesthesia or conscious sedation. 

Both devices resulted comparable for the combined end point of death, stroke, moderate to severe aortic regurgitation and the need of new definite pacemaker

The difference in stroke is surprising and difficult to explain since the number observed in this study for the Sapien 3 greatly exceeds the one observed in other studies, such as the SOURCE 3 and the PARTNER 3, which had used the same device. 

Between 30 days and one year there were no significant differences in stroke, therefore they were peri-procedural strokes. 


Read also: TCT 2020 | Fewer Symptoms and Events when Optimizing with iFR.


All-cause mortality resulted practically identical (17.6% with Evolut R vs 17.0% with Sapien 3; p=0.88), moderate to severe aortic regurgitation rate favored the Sapien 3 numerically, but not significantly (7.0% with Evolut R vs 4.5% with Sapien 3; p=0.35).

Definite pacemaker rate was relatively high and similar between devices (24.7% with Evolut R vs 20.2% with Sapien 3; p=0.25).

As regards the comparison between conscious sedation and general anesthesia, mortality, stroke, MI, infection, and kidney injury rates were equivalent between strategies. 


Read also: TCT 2020 | The Myth of Biodegradable Polymers Seems to Have Come to an End.


Conscious sedation saw shorter intensive care unit stay and shorter total hospital stay. A cost analysis that should favor conscious sedation is expected. 

Original Title: SOLVE-TAVI investigators. A 2 x 2 randomized trial of self-expandable vs balloon-expandable valves and general vs local anesthesia in patients undergoing transcatheter aortic valve implantation: 1-year result.

Reference: presentado por Feistritzer H-J en el congreso TCT 2020 virtual.


Subscribe to our weekly newsletter

Get the latest scientific articles on interventional cardiology

More articles by this author

Percutaneous Tricuspid Valve Replacement with Lux-Valve

Tricuspid regurgitation (TR) is a condition associated with poor quality of life, frequent hospitalizations due to heart failure, and increased mortality, even under optimal...

TAVR in Small Annuli: What Valve Should We Use?

One of the major challenges of severe aortic stenosis are patients with small aortic annuli, defined as ≤430 mm² aortic valve area. This condition...

ACC 2025 | TAVI in Low-Risk Patients: 5-Year Outcomes of EVOLUTE LOW RISK

Transcatheter aortic valve implantation (TAVI) is a valid alternative to surgery in low-risk patients with severe aortic stenosis. However, one of its main limitations...

ACC 2025 | BHF PROTECT-TAVI: Are Cerebral Protection Systems Necessary in TAVI?

TAVI has seen a steady increase in use, though stroke continues to be one of its unwanted complications, mostly ischemic and, less frequently, hemorrhagic. The...

LEAVE A REPLY

Please enter your comment!
Please enter your name here

Related Articles

SOLACI Sessionsspot_img

Recent Articles

Percutaneous Tricuspid Valve Replacement with Lux-Valve

Tricuspid regurgitation (TR) is a condition associated with poor quality of life, frequent hospitalizations due to heart failure, and increased mortality, even under optimal...

Transcatheter Pulmonary Valve Implantation with a Self-Expanding Valve: Outcomes at 3 Years

Pulmonary regurgitation (PR) is a common condition in patients who have undergone surgical repair of Tetralogy of Fallot or other pathologies involving the right...

Radial Patency in Coronary Procedures: Is Heparin Enough or Should We Aim for Distal Transradial Access?

Transradial access is the preferred route in most coronary procedures due to its proven reduction in mortality compared to transfemoral access. However, one of...