PMID- 31837559
OWN - NLM
STAT- MEDLINE
DCOM- 20210617
LR  - 20210617
IS  - 1879-2472 (Electronic)
IS  - 0049-3848 (Linking)
VI  - 186
DP  - 2020 Feb
TI  - Rivaroxaban in patients with mechanical heart valves: A pilot study.
PG  - 1-6
LID - S0049-3848(19)30530-4 [pii]
LID - 10.1016/j.thromres.2019.12.005 [doi]
AB  - BACKGROUND: Patients with mechanical heart valves are still not eligible for 
      treatment with direct oral anticoagulants (DOAC). We aimed to conduct a 
      proof-of-principle study investigating the anti-Xa inhibitor rivaroxaban as 
      antithrombotic treatment in patients with recent mechanical aortic valve 
      replacement. MATERIALS AND METHODS: Low-risk patients scheduled for elective 
      mechanical aortic valve replacement were treated with rivaroxaban 20 mg once 
      daily (OD) in a prospective cohort study, started on day 3 postoperatively and 
      given for 6 months. The study was registered at ClinicalTrials.gov 
      (#NCT02128841). RESULTS: Ten patients were included (median age, 48; range 39 to 
      60). Indication was aortic valve stenosis in 6 patients, aortic root aneurysm 
      with severe aortic valve regurgitation in 3 patients, and mixed 
      stenosis/regurgitation in 1 patient. Neither thromboembolic nor bleeding events 
      were observed, and no patient died. Absence of valve thrombosis was demonstrated 
      in all patients. On day 7, median D-dimers were 2723 mug/L (inter-quartile range 
      [IQR] 1672, 5695 mug/L), median TAT levels were 4.5 mug/L (IQR 4.1, 5.6 mug/L); and 
      median peak thrombin generation was 150 nM (IQR 91, 183). On day 90, median 
      D-dimers were 426 mug/L (IQR 278, 569), median TAT levels were 2.7 mug/L (IQR 2.2, 
      3.1), and median peak thrombin generation were 66 nM (IQR 62, 87). CONCLUSIONS: 
      Rivaroxaban 20 mg OD was safe and effective in a pilot study of 10 low risk 
      patients with mechanical aortic heart valve. Our results justify larger studies 
      investigating the application of anti-Xa inhibitors in patients with mechanical 
      heart valves.
CI  - Copyright (c) 2019. Published by Elsevier Ltd.
FAU - Roost, Eva
AU  - Roost E
AD  - Department of Cardiothoracic Surgery, Inselspital, Bern University Hospital, 
      University of Bern, CH-3010 Bern, Switzerland.
FAU - Weber, Alberto
AU  - Weber A
AD  - Department of Cardiothoracic Surgery, Inselspital, Bern University Hospital, 
      University of Bern, CH-3010 Bern, Switzerland.
FAU - Alberio, Lorenzo
AU  - Alberio L
AD  - Division of Haematology and Central Haematology Laboratory, Lausanne University 
      Hospital (CHUV), Lausanne, Switzerland; Faculty of Biology and Medicine, 
      University of Lausanne (UNIL), Lausanne, Switzerland. Electronic address: 
      lorenzo.alberio@chuv.ch.
FAU - Englberger, Lars
AU  - Englberger L
AD  - Department of Cardiothoracic Surgery, Inselspital, Bern University Hospital, 
      University of Bern, CH-3010 Bern, Switzerland.
FAU - Reineke, David
AU  - Reineke D
AD  - Department of Cardiothoracic Surgery, Inselspital, Bern University Hospital, 
      University of Bern, CH-3010 Bern, Switzerland.
FAU - Keller, Dorothee
AU  - Keller D
AD  - Department of Cardiothoracic Surgery, Inselspital, Bern University Hospital, 
      University of Bern, CH-3010 Bern, Switzerland.
FAU - Nagler, Michael
AU  - Nagler M
AD  - University Institute of Clinical Chemistry, Inselspital, Bern University 
      Hospital, University of Bern, CH-3010 Berne, Switzerland. Electronic address: 
      michael.nagler@insel.ch.
FAU - Carrel, Thierry
AU  - Carrel T
AD  - Department of Cardiothoracic Surgery, Inselspital, Bern University Hospital, 
      University of Bern, CH-3010 Bern, Switzerland.
LA  - eng
SI  - ClinicalTrials.gov/NCT02128841
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20191207
PL  - United States
TA  - Thromb Res
JT  - Thrombosis research
JID - 0326377
RN  - 0 (Anticoagulants)
RN  - 0 (Factor Xa Inhibitors)
RN  - 9NDF7JZ4M3 (Rivaroxaban)
SB  - IM
MH  - Anticoagulants
MH  - Aortic Valve/surgery
MH  - Factor Xa Inhibitors/therapeutic use
MH  - *Heart Valve Prosthesis/adverse effects
MH  - *Heart Valve Prosthesis Implantation
MH  - Humans
MH  - Middle Aged
MH  - Pilot Projects
MH  - Prospective Studies
MH  - Rivaroxaban/therapeutic use
OTO - NOTNLM
OT  - Blood coagulation/drug effects
OT  - Heart valve prosthesis
OT  - Rivaroxaban/therapeutic use
OT  - Thromboembolism
EDAT- 2019/12/15 06:00
MHDA- 2021/06/22 06:00
CRDT- 2019/12/15 06:00
PHST- 2019/08/29 00:00 [received]
PHST- 2019/11/12 00:00 [revised]
PHST- 2019/12/05 00:00 [accepted]
PHST- 2019/12/15 06:00 [pubmed]
PHST- 2021/06/22 06:00 [medline]
PHST- 2019/12/15 06:00 [entrez]
AID - S0049-3848(19)30530-4 [pii]
AID - 10.1016/j.thromres.2019.12.005 [doi]
PST - ppublish
SO  - Thromb Res. 2020 Feb;186:1-6. doi: 10.1016/j.thromres.2019.12.005. Epub 2019 Dec 
      7.