TCT 2019 | SCOPE I: Self-Expanding Valve Acurate Neo Head to Head with Sapien 3

Courtesy of SBHCI.

This work, which was presented during the TCT 2019 Scientific Sessions and simultaneously published in the Lancet, randomized patients to the ACURATE Neo prosthesis (n = 373) vs. the SAPIEN 3 (n = 367) in a head-to-head comparison involving 20 European sites. Transfemoral access was used in all patients.

Highlights TCT 2019

The study had a noninferiority design, and its primary endpoint was a composite of death, stroke, life-threatening bleeding, major cardiovascular complications, coronary occlusion, kidney injury, valve dysfunction requiring repeat procedure, heart failure hospitalization, and moderate to severe prosthetic valve regurgitation.

The criteria for noninferiority of ACURATE Neo vs. SAPIEN 3 was a margin of 7.7%.

The rate of primary events for the ACURATE Neo group was 23.7% vs. 16.5% for the SAPIEN 3 group. With these results, the self-expanding valve did not meet the noninferiority criteria. A secondary analysis even suggested SAPIEN 3 as superior.

There were no differences as regards death or stroke, but the rates for paravalvular leak were 3% for SAPIEN 3 vs. 9% for ACURATE Neo.

Courtesy of SBHCI.

Link to the SBHCI publication HERE

scope

scope-ot

Original Title: SCOPE I: A Randomized Trial of the ACURATE Neo vs. the SAPIEN 3 Bioprosthesis in Patients With Severe Aortic Stenosis.

Author of the Original Title: Jonas Lanz.


Subscribe to our weekly newsletter

Get the latest scientific articles on interventional cardiology

We are interested in your opinion. Please, leave your comments, thoughts, questions, etc., below. They will be most welcome.

More articles by this author

Evolution of Small Balloon-Expandable Valves

Small aortic rings (20 mm) have posed a significant challenge for both surgery and transcatheter aortic valve implantation (TAVI) due to their association with an...

TCT 2024 | Asymptomatic Severe Aortic Stenosis: What Should Be our Approach?

Approximately 3% of the population over 65 years old has aortic stenosis. Current guidelines recommend valve replacement for patients with symptoms or an ejection...

TCT 2024 | TRISCEND II

This randomized study included 400 patients; 267 were treated with EVOQUE valve and 133 with optimal medical treatment (OMT). After one-year follow-up, there were no...

TCT 2024 – ACCESS-TAVI: Comparing Percutaneous Access Closure Strategies After TAVI

Vascular access complications following transcatheter aortic valve implantation (TAVI) remain common. However, few studies compare vascular access closure methods.  Based on the CHOICE-CLOSURE and MASH...

LEAVE A REPLY

Please enter your comment!
Please enter your name here

Related Articles

SOLACI Sessionsspot_img

Recent Articles

Evolution of Small Balloon-Expandable Valves

Small aortic rings (20 mm) have posed a significant challenge for both surgery and transcatheter aortic valve implantation (TAVI) due to their association with an...

TCT 2024 | Asymptomatic Severe Aortic Stenosis: What Should Be our Approach?

Approximately 3% of the population over 65 years old has aortic stenosis. Current guidelines recommend valve replacement for patients with symptoms or an ejection...

TCT 2024 | FAVOR III EUROPA

The study FAVOR III EUROPA, a randomized trial, included 2,000 patients with chronic coronary syndrome, or stabilized acute coronary syndrome, and intermediate lesions. 1,008...