Effectiveness and Safety of Rivaroxaban and Low Molecular Weight Heparin in Cancer-Associated Venous Thromboembolism.

Background

Direct-acting oral anticoagulants (DOACs) are alternatives to low molecular weight heparin (LMWH) in most cancer-associated thrombosis (CAT) patients.

Objectives

This study sought to compare the effectiveness and safety of rivaroxaban and LMWH for venous thromboembolism (VTE) treatment in patients with an active cancer type not associated with a high risk of DOAC bleeding.

Methods

An analysis of electronic health records from January 2012 to December 2020 was performed. Patients were adults, had active cancer, experienced an index CAT event, and were treated with rivaroxaban or LMWH. Patients with cancers with an established high risk of bleeding on DOACs were excluded. Baseline covariates were balanced using propensity score-overlap weighting. HRs with 95% CIs were calculated.

Results

We identified 3,708 CAT patients treated with rivaroxaban (29.5%) or LMWH (70.5%). The median (25th-75th percentiles) time on anticoagulation was 180 (69-365) and 96 (40-336) days for rivaroxaban and LMWH patients. At 3 months, rivaroxaban was associated with a 31% reduced risk of recurrent VTE vs LMWH (4.2% vs 6.1%; HR: 0.69; 95% CI: 0.51-0.92). No difference in bleeding-related hospitalizations or all-cause mortality was observed (HR: 0.79; 95% CI: 0.55-1.13 and HR: 1.07; 95% CI: 0.85-1.35, respectively). Rivaroxaban reduced the recurrent VTE risk (HR: 0.74; 95% CI: 0.57-0.97) but not bleeding-related hospitalizations or all-cause mortality at 6 months. At 12 months, no difference was observed between cohorts for any of the previously mentioned outcomes.

Conclusions

Among active cancer patients experiencing VTE and not at high risk of bleeding on DOACs, rivaroxaban was associated with a reduced risk of recurrent VTE versus LMWHs at 3 and 6 months but not 12 months. (Observational Study in Cancer-Associated Thrombosis for Rivaroxaban-United States Cohort [OSCAR-US]; NCT04979780).

Informations de copyright

© 2023 The Authors.

Déclaration de conflit d'intérêts

This study was supported by Bayer AG. Data used in this study were obtained from Optum® under a license to Bayer AG (and provided to Dr Coleman under a third-party agreement) and are not publicly available. Dr Coleman has received grants or contracts from Bayer AG, Janssen Pharmaceuticals and Alexion Pharmaceuticals, consulting fees from Bayer AG, Janssen Pharmaceuticals and Alexion Pharmaceuticals; payments or honoraria from Medscape; and support for meeting attendance from Bayer AG. Dr Becattini has received consulting fees from Bayer AG, Bristol Myers Squibb, Pfizer and Daiichi Sankyo; and payments or honoraria from Bayer AG, Bristol Myers Squibb and Daiichi Sankyo. Dr Lee has received consulting fees from Bayer AG, LEO Pharma, Pfizer and Servier; and payments or honoraria from Bayer AG, Bristol Myers Squibb, LEO Pharma and Pfizer. Dr Carrier has received grants or contracts from Bristol Myers Squibb, Pfizer and LEO Pharma; and consulting fees from Bayer AG, Sanofi, Servier, Bristol Myers Squibb, LEO Pharma and Pfizer. Dr Cohen has received grants or contracts from Alexion, AstraZeneca, Bristol Myers Squibb and Pfizer; consulting fees from Alexion, AstraZeneca, Bayer AG, Bristol Myers Squibb and Pfizer; and payments or honoraria from Alexion, AstraZeneca, Bayer AG, Bristol Myers Squibb and Pfizer. Mr Abdelgawwad, Dr Psaroudakis, Dr Fatoba, Dr Rivera, Mr Schaefer, and Dr Brobert are employees of Bayer AG, and contributed to the design and conduct of the study; management and interpretation of the data; preparation, review, and approval of the manuscript; and decision to submit the manuscript for publication. All other authors have reported that they have no relationships relevant to the contents of this study to disclose.