Background: VTE is common in patients with cancer and can lead to serious complications and death. Relatively recently, the use of edoxaban or rivaroxaban was recommended by major guidelines for the treatment of cancer-associated VTE. Previous studies have demonstrated a higher risk of major bleeding when compared with low-molecular-weight heparin. Whether oral apixaban can be safely used in this setting is unknown.
Study design: Randomized, controlled, open-label, noninferiority clinical trial.
Setting: Multinational study with patients enrolled in nine European countries, Israel, and the United States.
Synopsis: Adult patients with confirmed cancer who had a new diagnosis of proximal lower-limb deep vein thrombosis or pulmonary embolism were enrolled in the trial. Of those enrolled, 1,170 patients underwent randomization to receive either oral apixaban twice daily or subcutaneous dalteparin once daily. The primary outcome was recurrent deep vein thrombosis or pulmonary embolism. The principal safety outcome was major bleeding. Researchers followed patients for 7 months after randomization. The primary outcome occurred in 32 of 576 patients (5.6%) in the apixaban group and 46 of 579 patients (7.9%) in the dalteparin group (hazard ratio, 0.63; 95% CI, 0.37-1.07). Major bleeding occurred in 22 patients (3.8%) in the apixaban group and 23 patients (4.0%) in the dalteparin group (HR, 0.82; 95% CI, 0.40-1.69). Limitations were the open-label trial design; the exclusion of patients with primary brain tumors, cerebral metastases, or acute leukemia; and the sample size being powered for the primary outcome, rather than to allow definitive conclusions about bleeding. Additionally, long-term data are needed as patients were followed for only 7 months.
Bottom line: Apixaban was noninferior to subcutaneous dalteparin for the treatment of VTE in patients with cancer and did not increase bleeding.
Citation: Agnelli G et al. Apixaban for the treatment of venous thromboembolism associated with cancer. N Engl J Med. 2020 Apr 23;382:1599-607. doi: 10.1056/NEJMoa1915103.
Dr. Hermansen is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.