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CC BY-NC-ND 4.0 · Thromb Haemost
DOI: 10.1055/a-2259-0662
Stroke, Systemic or Venous Thromboembolism

Comparison of Clinical Outcomes in Patients with Active Cancer Receiving Rivaroxaban or Low-Molecular-Weight Heparin: The OSCAR-UK Study

Alexander T. Cohen
1   Department of Haematological Medicine, Guy's and St Thomas' NHS Foundation Trust, King's College London, London, United Kingdom
,
Christopher Wallenhorst 
2   Institute for Epidemiology, Statistics and Informatics GmbH, Frankfurt am Main, Germany
,
Marcella Rivera
3   Bayer AG, Berlin, Germany at the time of study conduct, currently affiliated to Janssen Research and Development, Barcelona, Spain
,
Cihan Ay
4   Clinical Division of Haematology and Haemostaseology, Department of Medicine I, Medical University of Vienna, Vienna, Austria
,
Bernhard Schaefer
5   Bayer AG, Berlin, Germany
,
Khaled Abdelgawwad
5   Bayer AG, Berlin, Germany
,
George Psaroudakis
5   Bayer AG, Berlin, Germany
,
Gunnar Brobert
5   Bayer AG, Berlin, Germany
,
Anders Ekbom
6   Unit of Clinical Epidemiology, Department of Medicine, Karolinska Institute, Stockholm, Sweden
,
Agnes Y. Y. Lee
7   Division of Hematology, University of British Columbia and BC Cancer, Vancouver, Canada
,
Alok A. Khorana 
8   Cleveland Clinic and Case Comprehensive Cancer Center, Cleveland, Ohio, United States
,
Cecilia Becattini
9   Department of Internal and Emergency Medicine – Stroke Unit, University of Perugia, Perugia, Italy
,
Marc Carrier
10   Department of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, Ottawa, Canada
,
Craig I. Coleman 
11   Department of Pharmacy Practice, School of Pharmacy, University of Connecticut, Storrs, Connecticut, United States
,
Carlos Martinez 
2   Institute for Epidemiology, Statistics and Informatics GmbH, Frankfurt am Main, Germany
› Institutsangaben Funding The study was funded by Bayer.
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Abstract

Background In most patients with cancer-associated venous thromboembolism (CT), essentially those not at high risk of bleeding, guidelines recommend treatment with direct oral anticoagulants as an alternative to low-molecular-weight heparins (LMWHs). Population-based studies comparing these therapies are scarce.

Objectives To compare the risk of venous thromboembolism (VTE) recurrences, significant bleeding, and all-cause mortality in patients with CT receiving rivaroxaban or LMWHs.

Patients/Methods Using UK Clinical Practice Research Datalink data from 2013 to 2020, we generated a cohort of patients with first CT treated initially with either rivaroxaban or LMWH. Patients were observed 12 months for VTE recurrences, significant bleeds (major bleeds or clinically relevant nonmajor bleeding requiring hospitalization), and all-cause mortality. Overlap weighted sub-distribution hazard ratios (SHRs) compared rivaroxaban with LMWH in an intention-to-treat analysis.

Results The cohort consisted of 2,259 patients with first CT, 314 receiving rivaroxaban, and 1,945 LMWH, mean age 72.4 and 66.9 years, respectively. In the 12-month observational period, 184 person-years following rivaroxaban and 1,057 following LMWH, 10 and 66 incident recurrent VTE events, 20 and 102 significant bleeds, and 10 and 133 deaths were observed in rivaroxaban and LMWH users, respectively. The weighted SHR at 12 months for VTE recurrences in rivaroxaban compared with LMWH were 0.80 (0.37–1.73); for significant bleeds 1.01 (0.57–1.81); and for all-cause mortality 0.49 (0.23–1.06).

Conclusion Patients with CT, not at high risk of bleeding, treated with either rivaroxaban or LMWH have comparable effectiveness and safety outcomes. This supports the recommendation that rivaroxaban is a reasonable alternative to LMWH for the treatment of CT.

Keywords

venous thromboembolism - anticoagulants - cancer

Note

Trial registration number: NCT05112666


Supplementary Material



Publikationsverlauf

Eingereicht: 07. Juli 2023

Angenommen: 08. Dezember 2023

Accepted Manuscript online:
01. Februar 2024

Artikel online veröffentlicht:
08. April 2024

© 2024. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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