PMID- 35787831
OWN - NLM
STAT- MEDLINE
DCOM- 20221102
LR  - 20221102
IS  - 1878-0938 (Electronic)
IS  - 1878-0938 (Linking)
VI  - 44
DP  - 2022 Nov
TI  - Leaflet Thickening and Motion After Transcatheter Aortic Valve Replacement: 
      Design and Rationale of the Rotterdam Edoxaban Trial.
PG  - 67-70
LID - S1553-8389(22)00305-0 [pii]
LID - 10.1016/j.carrev.2022.06.011 [doi]
AB  - BACKGROUND: Multislice computed tomography (MSCT) may reveal hypo-attenuated 
      leaflet thickening (HALT) and/or reduced leaflet motion (RELM) in approximately 
      15 % of patients after transcatheter aortic valve replacement (TAVR). These 
      supposedly thrombogenic phenomena may be associated with neurological events and 
      increased transprosthetic gradients. It is unclear whether oral anticoagulant 
      therapy -specifically a factor Xa inhibitor- could affect the incidence of 
      HALT/RELM. STUDY DESIGN: The Rotterdam EDOXaban (REDOX) trial is an 
      investigator-initiated, single-center, prospective registry in which 100 patients 
      with no formal indication for oral anticoagulant drugs or dual antiplatelet 
      therapy, will receive a 3-month treatment with edoxaban, followed by a MSCT to 
      detect HALT/RELM. The primary endpoint is the incidence of HALT at 3-months 
      follow-up. Secondary endpoints include the incidence of RELM at 3 months; change 
      in transprosthetic gradients at 1 year and the clinical composite endpoint of 
      all-cause death, myocardial infarction (MI), ischemic stroke, systemic 
      thromboembolism, valve thrombosis and major bleeding (International Society on 
      Thrombosis and Hemostasis [ISTH] definition) at 1 year follow up. The study is 
      powered to demonstrate with 90 % statistical power and a 0.025 alpha a 4 % 
      incidence of HALT with edoxaban as compared to the expected 15 % rate with an 
      antiplatelet regimen and will enroll 100 patients to account for loss of 
      follow-up or CT-drop out. CONCLUSION: The REDOX trial will investigate the 
      short-term effect of an Xa-inhibitor on the incidence of HALT after TAVR. 
      (ClinicalTrials.gov Identifier: NCT04171726).
CI  - Copyright (c) 2022 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - van Wiechen, Maarten P
AU  - van Wiechen MP
AD  - Department of Cardiology, Erasmus University Medical Center, Rotterdam, the 
      Netherlands.
FAU - El Azzouzi, Ikram
AU  - El Azzouzi I
AD  - Department of Cardiology, Erasmus University Medical Center, Rotterdam, the 
      Netherlands.
FAU - Knol, Wiebe G
AU  - Knol WG
AD  - Department of Radiology and Nuclear Medicine, Erasmus University Medical Center, 
      Rotterdam, the Netherlands.
FAU - Adrichem, Rik
AU  - Adrichem R
AD  - Department of Cardiology, Erasmus University Medical Center, Rotterdam, the 
      Netherlands.
FAU - Hokken, Thijmen W
AU  - Hokken TW
AD  - Department of Cardiology, Erasmus University Medical Center, Rotterdam, the 
      Netherlands.
FAU - Ooms, Joris F
AU  - Ooms JF
AD  - Department of Cardiology, Erasmus University Medical Center, Rotterdam, the 
      Netherlands.
FAU - de Ronde-Tillmans, Marjo J
AU  - de Ronde-Tillmans MJ
AD  - Department of Cardiology, Erasmus University Medical Center, Rotterdam, the 
      Netherlands.
FAU - Daemen, Joost
AU  - Daemen J
AD  - Department of Cardiology, Erasmus University Medical Center, Rotterdam, the 
      Netherlands.
FAU - de Jaegere, Peter P
AU  - de Jaegere PP
AD  - Department of Cardiology, Erasmus University Medical Center, Rotterdam, the 
      Netherlands.
FAU - Hirsch, Alexander
AU  - Hirsch A
AD  - Department of Cardiology, Erasmus University Medical Center, Rotterdam, the 
      Netherlands; Department of Radiology and Nuclear Medicine, Erasmus University 
      Medical Center, Rotterdam, the Netherlands.
FAU - Budde, Ricardo P J
AU  - Budde RPJ
AD  - Department of Cardiology, Erasmus University Medical Center, Rotterdam, the 
      Netherlands; Department of Radiology and Nuclear Medicine, Erasmus University 
      Medical Center, Rotterdam, the Netherlands.
FAU - Van Mieghem, Nicolas M
AU  - Van Mieghem NM
AD  - Department of Cardiology, Erasmus University Medical Center, Rotterdam, the 
      Netherlands. Electronic address: n.vanmieghem@erasmusmc.nl.
LA  - eng
SI  - ClinicalTrials.gov/NCT04171726
PT  - Clinical Trial
PT  - Journal Article
DEP - 20220617
PL  - United States
TA  - Cardiovasc Revasc Med
JT  - Cardiovascular revascularization medicine : including molecular interventions
JID - 101238551
RN  - 0 (Anticoagulants)
RN  - NDU3J18APO (edoxaban)
RN  - 0 (Factor Xa Inhibitors)
RN  - 0 (Platelet Aggregation Inhibitors)
SB  - IM
MH  - Humans
MH  - Anticoagulants/adverse effects
MH  - Aortic Valve/diagnostic imaging/surgery
MH  - Factor Xa Inhibitors/adverse effects
MH  - *Heart Valve Prosthesis/adverse effects
MH  - Platelet Aggregation Inhibitors/adverse effects
MH  - *Thrombosis/diagnostic imaging/etiology/prevention & control
MH  - *Transcatheter Aortic Valve Replacement/adverse effects
OTO - NOTNLM
OT  - Computed tomography
OT  - HALT
OT  - RELM
OT  - Transcatheter aortic valve replacement
COIS- Declaration of competing interest Joost Daemen received institutional research 
      support from Abbott Vascular, Boston Scientific, Medtronic, Pie Medical and 
      PulseCath BV, and consultancy and speaker fees from Boston Scientific, ReCor, Pie 
      Medical, Medtronic and PulseCath BV. Nicolas Van Mieghem received research grants 
      from Abbott, Boston Scientific, Edwards Lifesciences, Teleflex, Medtronic, 
      Daiichi Sankyo, PulseCath BV. All other authors declared no conflict of interest.
EDAT- 2022/07/06 06:00
MHDA- 2022/10/26 06:00
CRDT- 2022/07/05 17:52
PHST- 2021/10/28 00:00 [received]
PHST- 2022/06/06 00:00 [revised]
PHST- 2022/06/10 00:00 [accepted]
PHST- 2022/07/06 06:00 [pubmed]
PHST- 2022/10/26 06:00 [medline]
PHST- 2022/07/05 17:52 [entrez]
AID - S1553-8389(22)00305-0 [pii]
AID - 10.1016/j.carrev.2022.06.011 [doi]
PST - ppublish
SO  - Cardiovasc Revasc Med. 2022 Nov;44:67-70. doi: 10.1016/j.carrev.2022.06.011. Epub 
      2022 Jun 17.