dc.date.accessioned | 2024-03-01T18:10:26Z | |
dc.date.available | 2024-03-01T18:10:26Z | |
dc.date.created | 2023-11-06T14:57:48Z | |
dc.date.issued | 2023 | |
dc.identifier.citation | Dodgson, Christopher Alexander Steele Beitnes, Jan Otto Kløve, Sophie Foss Herstad, Jon Opdahl, Anders Undseth, Ragnhild Marie Eek, Christian Broch, Kaspar Gullestad, Lars Aaberge, Lars Lunde, Ketil Bendz, Bjørn Lie, Øyvind Haugen . An investigator-sponsored pragmatic randomized controlled trial of AntiCoagulation vs AcetylSalicylic Acid after Transcatheter Aortic Valve Implantation: Rationale and design of ACASA-TAVI. American Heart Journal. 2023, 265, 225-232 | |
dc.identifier.uri | http://hdl.handle.net/10852/108867 | |
dc.description.abstract | Background
The optimal antithrombotic therapy after transcatheter aortic valve implantation (TAVI) is unknown. Bioprosthetic valve dysfunction (BVD) is associated with adverse outcomes and may be prevented by anticoagulation therapy. A dedicated randomized trial comparing monotherapy NOAC to single antiplatelet therapy has not been performed previously. We hypothesize that therapy with any anti-factor Xa NOAC will reduce BVD compared to antiplatelet therapy, without compromising safety.
Methods
ACASA-TAVI is a multicenter, prospective, randomized, open-label, blinded endpoint, all-comers trial comparing a monotherapy anti-factor Xa NOAC strategy (intervention arm) with a single antiplatelet therapy strategy (control arm) after successful TAVI. Three-hundred and sixty patients without indication for oral anticoagulation will be randomized in a 1:1 ratio to either apixaban 5 mg twice per day, edoxaban 60 mg daily, or rivaroxaban 20 mg daily for 12 months followed by acetylsalicylic acid 75 mg daily indefinitely, or to acetylsalicylic acid 75 mg daily indefinitely. The 2 co-primary outcomes are (1) incidence of Hypo-Attenuated Leaflet Thickening (HALT) on 4-dimensional cardiac CT at 12 months, and (2) a Safety Composite of VARC-3 bleeding events, thromboembolic events (myocardial infarction and stroke), and death from any cause, at 12 months.
Results
The first 100 patients had a mean age of 74 ± 3.6 years, 33% were female, the average body-mass index was 27.9 ± 4.4 kg/m2, and 15% were smokers. A balloon-expanded valve was used in 82% and a self-expandable valve in 18%.
Conclusions
The trial is planned, initiated, funded, and conducted without industry involvement. | |
dc.language | EN | |
dc.rights | Attribution 4.0 International | |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0/ | |
dc.title | An investigator-sponsored pragmatic randomized controlled trial of AntiCoagulation vs AcetylSalicylic Acid after Transcatheter Aortic Valve Implantation: Rationale and design of ACASA-TAVI | |
dc.title.alternative | ENEngelskEnglishAn investigator-sponsored pragmatic randomized controlled trial of AntiCoagulation vs AcetylSalicylic Acid after Transcatheter Aortic Valve Implantation: Rationale and design of ACASA-TAVI | |
dc.type | Journal article | |
dc.creator.author | Dodgson, Christopher Alexander Steele | |
dc.creator.author | Beitnes, Jan Otto | |
dc.creator.author | Kløve, Sophie Foss | |
dc.creator.author | Herstad, Jon | |
dc.creator.author | Opdahl, Anders | |
dc.creator.author | Undseth, Ragnhild Marie | |
dc.creator.author | Eek, Christian | |
dc.creator.author | Broch, Kaspar | |
dc.creator.author | Gullestad, Lars | |
dc.creator.author | Aaberge, Lars | |
dc.creator.author | Lunde, Ketil | |
dc.creator.author | Bendz, Bjørn | |
dc.creator.author | Lie, Øyvind Haugen | |
cristin.unitcode | 185,53,15,13 | |
cristin.unitname | Kardiologisk avdeling | |
cristin.ispublished | true | |
cristin.fulltext | original | |
cristin.qualitycode | 1 | |
dc.identifier.cristin | 2192770 | |
dc.identifier.bibliographiccitation | info:ofi/fmt:kev:mtx:ctx&ctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=American Heart Journal&rft.volume=265&rft.spage=225&rft.date=2023 | |
dc.identifier.jtitle | American Heart Journal | |
dc.identifier.volume | 265 | |
dc.identifier.startpage | 225 | |
dc.identifier.endpage | 232 | |
dc.identifier.doi | https://doi.org/10.1016/j.ahj.2023.08.010 | |
dc.type.document | Tidsskriftartikkel | |
dc.type.peerreviewed | Peer reviewed | |
dc.source.issn | 0002-8703 | |
dc.type.version | PublishedVersion | |