Rivaroxaban in patients with mechanical heart valves: A pilot study.

Roost, Eva; Weber, Alberto; Alberio, Lorenzo; Englberger, Lars; Reineke, David; Keller, Dorothée; Nagler, Michael; Carrel, Thierry (2020). Rivaroxaban in patients with mechanical heart valves: A pilot study. Thrombosis research, 186, pp. 1-6. Elsevier 10.1016/j.thromres.2019.12.005

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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 μg/L (inter-quartile range [IQR] 1672, 5695 μg/L), median TAT levels were 4.5 μg/L (IQR 4.1, 5.6 μg/L); and median peak thrombin generation was 150 nM (IQR 91, 183). On day 90, median D-dimers were 426 μg/L (IQR 278, 569), median TAT levels were 2.7 μg/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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiovascular Surgery
04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Institute of Clinical Chemistry

UniBE Contributor:

Roost, Eva; Reineke, David Christian; Nagler, Michael and Carrel, Thierry

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0049-3848

Publisher:

Elsevier

Language:

English

Submitter:

Karin Balmer

Date Deposited:

09 Nov 2020 15:20

Last Modified:

08 Dec 2020 02:30

Publisher DOI:

10.1016/j.thromres.2019.12.005

PubMed ID:

31837559

Uncontrolled Keywords:

Blood coagulation/drug effects Heart valve prosthesis Rivaroxaban/therapeutic use Thromboembolism

BORIS DOI:

10.7892/boris.147752

URI:

https://boris.unibe.ch/id/eprint/147752

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