; Burgdorf, Christof ; Linke, Axel ; Redwood, Simon ; Hilker, Michael ; Joner, Michael ; Thiele, Holger
; Conzelmann, Lars ; Conradi, Lenard ; Kerber, Sebastian ; Thilo, Christian ; Toggweiler, Stefan ; Prendergast, Bernard ; Husser, Oliver ; Stortecky, Stefan ; Deckarm, Sarah ; Künzi, Arnaud ; Heg, Dik ; Walther, Thomas ; Windecker, Stephan ; Pilgrim, Thomas | Item type: | Article | ||||
|---|---|---|---|---|---|
| Journal or Publication Title: | Circulation: Cardiovascular Interventions | ||||
| Publisher: | LIPPINCOTT WILLIAMS & WILKINS | ||||
| Place of Publication: | PHILADELPHIA | ||||
| Volume: | 16 | ||||
| Number of Issue or Book Chapter: | 7 | ||||
| Date: | 2023 | ||||
| Institutions: | Medicine > Lehrstuhl für Herz-, Thorax- und herznahe Gefäßchirurgie | ||||
| Identification Number: |
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| Keywords: | VALVULAR HEART-DISEASE; END-POINT DEFINITIONS; PARAVALVULAR REGURGITATION; 1-YEAR OUTCOMES; ASSOCIATION; REPLACEMENT; MANAGEMENT; bioprosthesis; randomized trial; TAVI; TAVR; transcatheter heart valves | ||||
| Dewey Decimal Classification: | 600 Technology > 610 Medical sciences Medicine | ||||
| Status: | Published | ||||
| Refereed: | Yes, this version has been refereed | ||||
| Created at the University of Regensburg: | Yes | ||||
| Item ID: | 76290 |
Abstract
BACKGROUND: In the SCOPE I trial (Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis), transcatheter aortic valve implantation with the self-expanding ACURATE neo (NEO) did not meet noninferiority compared with the balloon-expandable SAPIEN 3 (S3) device regarding a composite end point at 30 days due to higher rates of prosthetic valve regurgitation ...

Abstract
BACKGROUND: In the SCOPE I trial (Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis), transcatheter aortic valve implantation with the self-expanding ACURATE neo (NEO) did not meet noninferiority compared with the balloon-expandable SAPIEN 3 (S3) device regarding a composite end point at 30 days due to higher rates of prosthetic valve regurgitation and acute kidney injury. Data on long-term durability of NEO are scarce. Here, we report whether early differences between NEO and S3 translate into differences in clinical outcomes or bioprosthetic valve failure 3 years after transcatheter aortic valve implantation. METHODS: Patients with severe aortic stenosis were randomized to transfemoral transcatheter aortic valve implantation with NEO or S3 at 20 European centers. Clinical outcomes at 3 years are compared using Cox proportional or Fine-Gray subdistribution hazard models by intention-to-treat. Bioprosthetic valve failure is reported for the valve-implant cohort. RESULTS: Among 739 patients, 84 of 372 patients (24.3%) had died in the NEO and 85 of 367 ( 25%) in the S3 group at 3 years. Comparing NEO with S3, the 3- year rates of all-cause death (hazard ratio, 0.98 [95% CI, 0.73- 1.33]), stroke (subhazard ratio, 1.04 [95% CI, 0.56- 1.92]), and hospitalization for congestive heart failure ( subhazard ratio, 0.74 [95% CI, 0.51-1.07]) were similar between the groups. Aortic valve reinterventions were required in 4 NEO and 3 S3 patients (subhazard ratio, 1.32 [ 95% CI, 0.30- 5.85]). New York Heart Association functional class <= II was observed in 84% (NEO) and 85% (S3), respectively. Mean gradients remained lower after NEO at 3 years (8 versus 12 mm Hg; P<0.001).' CONCLUSIONS: Early differences between NEO and S3 did not translate into significant differences in clinical outcomes or bioprosthetic valve failure throughout 3 years. REGISTRATION: URL: https://clinicaltrials.gov, Unique identifier: NCT03011346.
Metadata last modified: 18 Mar 2025 10:11
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