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Rivaroxaban vs Dalteparin in Cancer-Associated Thromboembolism: A Randomized Trial
Benjamin Planquette1, Laurent Bertoletti2, Anaïs Charles-Nelson3
1Service de Pneumologie et Soins Intensifs, Hôpital Européen Georges Pompidou, APHP, Université de Paris, Paris, France; INSERM UMR_S1140, Innovations Thérapeutiques en Hémostase, Laboratoire de Chirurgie expérimentale, Fondation Alain Carpentier, Paris, France; F-CRIN INNOVTE Network, Saint-Etienne, France.
Direct oral anticoagulants (DOACs) showed similar efficacy and safety to dalteparin for cancer-associated VTE. While not meeting noninferiority criteria due to sample size, results align with prior DOAC studies.
Area of Science:
- Hematology
- Oncology
- Pharmacology
Background:
- Cancer-associated venous thromboembolism (VTE) poses a significant clinical challenge.
- Low-molecular-weight heparin (LMWH) is a standard treatment, but direct oral anticoagulants (DOACs) offer an alternative.
- Rivaroxaban is a commonly used DOAC for VTE treatment.
Purpose of the Study:
- To compare the efficacy and safety of rivaroxaban versus dalteparin in patients with cancer-associated VTE.
- To determine if rivaroxaban is noninferior to dalteparin for recurrent VTE prevention.
Main Methods:
- A randomized, open-label, noninferiority trial involving 158 patients with active cancer and VTE.
- Patients received therapeutic doses of rivaroxaban or dalteparin for 3 months.
- Primary outcome: cumulative incidence of recurrent VTE at 3 months.
Main Results:
- Recurrent VTE occurred in 6.4% of the rivaroxaban group and 10.1% of the dalteparin group (SHR, 0.75; 95% CI, 0.21-2.66).
- Major bleeding rates were 1.4% for rivaroxaban and 3.7% for dalteparin (SHR, 0.36; 95% CI, 0.04-3.43).
- Overall mortality was similar between groups (25.7% vs 23.8%).
Conclusions:
- The trial was underpowered to establish noninferiority for rivaroxaban versus dalteparin in cancer-associated VTE.
- Efficacy and safety findings were consistent with previous studies on DOACs in this population.
- An updated meta-analysis of DOACs versus LMWH in cancer-associated VTE is provided.
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