Final 3-Year Outcomes of a Randomized Trial Comparing a Self-Expanding to a Balloon-Expandable Transcatheter Aortic Valve.

Lanz, Jonas; Möllmann, Helge; Kim, Won-Keun; 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

doi:10.1161/CIRCINTERVENTIONS.123.012873

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Titel:: Final 3-Year Outcomes of a Randomized Trial Comparing a Self-Expanding to a Balloon-Expandable Transcatheter Aortic Valve.
Dokumenttyp:: Randomized Controlled Trial; Journal Article; Research Support, Non-U.S. Gov't
Autor(en):: Lanz, Jonas; Möllmann, Helge; Kim, Won-Keun; 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
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.
Zeitschriftentitel:: Circ Cardiovasc Interv
Jahr:: 2023
Band / Volume:: 16
Heft / Issue:: 7
Volltext / DOI:: doi:10.1161/CIRCINTERVENTIONS.123.012873
PubMed:: http://view.ncbi.nlm.nih.gov/pubmed/37417229
Print-ISSN:: 1941-7640
TUM Einrichtung:: Klinik für Herz- und Kreislauferkrankungen im Erwachsenenalter (DHM) (Prof. Schunkert)
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mediaTUM Gesamtbestand Einrichtungen Schools TUM School of Medicine and Health Departments Clinical Medicine Lehr- und Forschungskooperationen mit den Kliniken und Instituten am Deutschen Herzzentrum Klinik für Herz- und Kreislauferkrankungen im Erwachsenenalter (DHM) (Prof. Schunkert)2023