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

Craig I Coleman; Kimberly Snow Caroti; Khaled Abdelgawwad; George Psaroudakis; Samuel Fatoba; Marcela Rivera; Bernhard Schaefer; Gunnar Brobert; Alok A Khorana; Cecilia Becattini; Agnes Y Y Lee; Anders Ekbom; Marc Carrier; Christopher Brescia; Alexander T Cohen

doi:10.1016/j.jaccao.2022.10.014

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

JACC CardioOncol. 2023 Feb 7;5(2):189-200. doi: 10.1016/j.jaccao.2022.10.014. eCollection 2023 Apr.

Authors

Affiliations

¹ School of Pharmacy, University of Connecticut, Storrs, Connecticut, USA.
² Evidence-Based Practice Center, Hartford Hospital, Hartford, Connecticut, USA.
³ Bayer AG, Berlin, Germany.
⁴ Cleveland Clinic and Case Comprehensive Cancer Center, Cleveland, Ohio, USA.
⁵ Department of Internal and Emergency Medicine, Stroke Unit, University of Perugia, Perugia, Italy.
⁶ University of British Columbia and BC Cancer, Vancouver, Canada.
⁷ Unit of Clinical Epidemiology, Department of Medicine, Karolinska Institute, Stockholm, Sweden.
⁸ Department of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, Ottawa, Canada.
⁹ Freshtech IT, LLC, East Hartford, Connecticut, USA.
¹⁰ Department of Haematological Medicine, Guy's and St Thomas' National Health Service Foundation Trust, King's College London, London, United Kingdom.

Abstract

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).

Keywords: cancer-associated thrombosis; low molecular-weight heparin; real-world evidence; rivaroxaban; venous thromboembolism.

Associated data

ClinicalTrials.gov/NCT04979780