Study Confirms Benefit of Rivaroxaban for Secondary Prevention of Venous Thromboembolism in Patients With Cancer

New observational data from 8 years of clinical practice has confirmed that the Factor Xa inhibitor rivaroxaban (Xarelto; Johnson & Johnson) is associated with comparable efficacy and safety to apixaban for the treatment of cancer-associated thromboembolism (CAT) in a broad cohort of cancer types. These results will be featured in an oral presentation at the American Society of Hematology (ASH) 64th Annual Meeting and Exposition.

Patients with CAT are at a higher risk of venous thromboembolism (VTE), which is the second-leading cause of death in patients with cancer. VTE occurs when a blood clot forms in a vein and affects between 300,000 and 600,000 Americans annually. It is commonly caused by surgery, cancer, immobilization, and hospitalization.

Data from the Observational Study in Cancer-Associated Thrombosis for Rivaroxaban (OSCAR) found that rivaroxaban showed non-inferiority for the composite outcome of recurrent VTE or any bleeding resulting in hospitalization for treatment of patients with CAT.

“The OSCAR study provides robust, real-world evidence in patients with CAT and builds upon previous Xarelto safety and efficacy data observed in both clinical practice and in randomized clinical trials,” said Craig I. Coleman, PharmD, in a press release. “The data show Xarelto can be an effective option for these patients who are at an increased risk of potentially life-threatening blood clots.”

The study used United States Optum De-Identified electronic health data from January 2013 to December 2020. It included a cohort of 2437 patients aged 18 years and older with CAT for whom direct-acting oral anticoagulants (DOACs) are endorsed by guidelines as alternatives to low molecular weight heparin. Patients with active cancer, excluding esophageal, gastric, unresected colorectal, bladder, leukemia, or central nervous system cancers were enrolled after experiencing a hospital, emergency department, or observation unit admission for VTE or a pulmonary embolism event.

The 8-year study assessed the time to first composite event of recurrent VTE or any bleeding resulting in hospitalization at a minimum follow-up of 3 months. Other outcomes included the composite of recurrent VTE or any critical organ bleeding, recurrent VTE, any bleeding resulting in hospitalization, and any critical organ bleeding at 3 and 6 months.

At those time points, rivaroxaban was found to be as effective and safe as apixaban in the composite outcome of recurrent VTE or bleeding-related hospitalization. At 3 months, patients receiving rivaroxaban had a numerically lower rate of the primary endpoint. No significant differences were observed between groups for this outcome at 6 months or for other outcomes at 3 or 6 months.

Earlier studies, such as SELECT-D and CONKO-11, demonstrated that changing from a low molecular weight heparin to rivaroxaban was associated with a reduction in risk of recurrent thrombosis and improved patient satisfaction.

“For more than a decade, Xarelto has been a leading DOAC, providing an important treatment option for those who prefer an oral alternative over treatment with low molecular weight heparin by injection,” said Avery Ince, vice president of medical affairs for cardiovascular and metabolism at Janssen Scientific Affairs, LLC, in the press release. “This retrospective study reasserts the broad clinical utility of Xarelto and the benefit of oral therapy for these patients.”

REFERENCE

Real-World Study Confirms Benefit of Xarelto (rivaroxaban) for Secondary Prevention of Venous Thromboembolism in Cancer Patients. News release. Johnson & Johnson; December 9, 2022. Accessed December 9, 2022. https://www.jnj.com/real-world-study-confirms-benefit-of-xarelto-rivaroxaban-for-secondary-prevention-of-venous-thromboembolism-in-cancer-patients