PMID- 37634655
OWN - NLM
STAT- Publisher
LR  - 20231012
IS  - 1097-6744 (Electronic)
IS  - 0002-8703 (Linking)
VI  - 265
DP  - 2023 Nov
TI  - An investigator-sponsored pragmatic randomized controlled trial of 
      AntiCoagulation vs AcetylSalicylic Acid after Transcatheter Aortic Valve 
      Implantation: Rationale and design of ACASA-TAVI.
PG  - 225-232
LID - S0002-8703(23)00208-9 [pii]
LID - 10.1016/j.ahj.2023.08.010 [doi]
AB  - 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/m(2), 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. TRIAL REGISTRATION: 
      ClinicalTrials.gov Identifier NCT05035277.
CI  - Copyright (c) 2023 The Author(s). Published by Elsevier Inc. All rights reserved.
FAU - Dodgson, Christopher S
AU  - Dodgson CS
AD  - Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway; 
      Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, 
      Norway.
FAU - Beitnes, Jan Otto
AU  - Beitnes JO
AD  - Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.
FAU - Klove, Sophie F
AU  - Klove SF
AD  - Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.
FAU - Herstad, Jon
AU  - Herstad J
AD  - Department of Cardiology, Haukeland University Hospital, Bergen, Norway.
FAU - Opdahl, Anders
AU  - Opdahl A
AD  - Department of Cardiology, Oslo University Hospital Ulleval, Oslo, Norway.
FAU - Undseth, Ragnhild
AU  - Undseth R
AD  - The Intervention Centre, Oslo University Hospital, Oslo, Norway.
FAU - Eek, Christian H
AU  - Eek CH
AD  - Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.
FAU - Broch, Kaspar
AU  - Broch K
AD  - Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway; 
      Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, 
      Norway; K. G. Jebsen Cardiac Research Centre, University of Oslo, Oslo, Norway.
FAU - Gullestad, Lars
AU  - Gullestad L
AD  - Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway; 
      Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, 
      Norway; K. G. Jebsen Cardiac Research Centre, University of Oslo, Oslo, Norway.
FAU - Aaberge, Lars
AU  - Aaberge L
AD  - Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.
FAU - Lunde, Ketil
AU  - Lunde K
AD  - Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.
FAU - Bendz, Bjorn
AU  - Bendz B
AD  - Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway; 
      Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, 
      Norway.
FAU - Lie, Oyvind H
AU  - Lie OH
AD  - Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway. 
      Electronic address: oyvlie@gmail.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT05035277
PT  - Journal Article
DEP - 20230825
PL  - United States
TA  - Am Heart J
JT  - American heart journal
JID - 0370465
SB  - IM
COIS- Conflict of interest None reported.
EDAT- 2023/08/28 00:41
MHDA- 2023/08/28 00:41
CRDT- 2023/08/27 19:24
PHST- 2023/06/01 00:00 [received]
PHST- 2023/08/20 00:00 [revised]
PHST- 2023/08/21 00:00 [accepted]
PHST- 2023/08/28 00:41 [pubmed]
PHST- 2023/08/28 00:41 [medline]
PHST- 2023/08/27 19:24 [entrez]
AID - S0002-8703(23)00208-9 [pii]
AID - 10.1016/j.ahj.2023.08.010 [doi]
PST - ppublish
SO  - Am Heart J. 2023 Nov;265:225-232. doi: 10.1016/j.ahj.2023.08.010. Epub 2023 Aug 
      25.