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

BACKGROUND

In most patients with cancer-associated venous thromboembolism (CAT), 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 CAT, receiving rivaroxaban or LMWHs.

PATIENTS/METHODS

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

RESULTS

The cohort consisted of 2259 patients with first CAT, 314 receiving rivaroxaban, and 1945 LMWH, mean age 72.4 and 66.9 years, respectively. In the 12-month observational period, 184 person-years following rivaroxaban and 1057 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 CAT, 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 CAT.

Informations de copyright

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/).

Déclaration de conflit d'intérêts

A.T. Cohen reports grants, consulting fees and honoraria from Alexion/AstraZeneca, grants, consulting fees and honoraria from Bristol Myers Squibb/Pfizer, and consulting fees and honoraria from Bayer AG. C. Wallenhorst and C. Martinez are employees of the Institute for Epidemiology, Statistics and Informatics GmbH. The Institute for Epidemiology, Statistics and Informatics GmbH has received support from Bayer for the conduct of the submitted work and has received grants from Astra Zeneca, Bayer, Bristol-Myers Squibb and CSL Behring outside the submitted work. M. Rivera was an employee of Bayer AG at the time of study conduct and is currently an employee of Janssen Research and Development. C. Ay reports honoraria from Bayer AG, BMS/Pfizer, Daiichi-Sankyo and Sanofi. B. Schaefer was an employee of Bayer AG at the time of study conduct and is current a consultant for Bayer AG. K. Abdelgawwad and G. Psaroudakis are employees of Bayer AG. G. Brobert is a consultant for Bayer AG. A. Ekbom reports no conflicts of interest. A.Y.Y. Lee reports consulting fees and honoraria from Bayer AG, consulting fees and honoraria from LEO Pharma, consulting fees and honoraria from Pfizer, consulting fees from Servier, and honoraria from Bristol Myers Squibb. A.A. Khorana reports consulting fees, honoraria, and travel support from Bayer AG, consulting fees, honoraria and travel support from Janssen, consulting fees and honoraria from Bristol Myers Squibb, consulting fees and honoraria from Anthos, consulting fees and honoraria from Pfizer, consulting fees and honoraria from Sanofi, and honoraria from WebMD. C. Becattini reports consulting fees and honoraria from Bayer AG, consulting fees and honoraria from Bristol Myers Squibb, consulting fees and honoraria from Daiichi Sankyo, and consulting fees from Pfizer. M. Carrier reports grants and consulting fees from Pfizer, grants and consulting fees from LEO Pharma, grants and consulting fees from Bristol Myers Squibb, consulting fees from Bayer AG, consulting fees from Sanofi, and consulting fees from Servier. C.I. Coleman reports grants, consulting fees, and travel support from Bayer AG, grants and consulting fees from Janssen Pharmaceuticals, grants and consulting fees from Alexion Pharmaceutical, and honoraria from Medscape.