ABSTRACT
OBJECTIVE: The purpose of this study is to evaluate the efficacy and safety of rivaroxaban in patients with venous thromboembolism and active malignancy, given the paucity of clinical data with the use of direct Xa inhibitors in this high-risk population. PATIENTS AND METHODS: Consecutive patients treated with rivaroxaban for deep vein thrombosis or pulmonary embolism, enrolled into Mayo Thrombophilia Clinic Direct Oral Anticoagulants Registry between March 1, 2013, and April 30, 2015, were followed prospectively to evaluate the efficacy and safety of this therapy. RESULTS: Of the 404 venous thromboembolism patients in the registry, 296 received rivaroxaban and had at least 3 months of follow-up. Of these, 118 (40%) had active malignancy (51% female, mean age 66 ± 10 years) and 178 had no cancer (47% female, mean age 55 ± 15 years). The 3 most common cancer locations were genitourinary (23.6%), gastrointestinal (20.3%), and lung (13.5%). There was no difference in venous thromboembolism recurrence between the malignant (3.3%) and the nonmalignant (2.8%) venous thromboembolism groups (P = .533). Borderline higher rates for major bleeding (P = .06) and nonmajor clinically relevant bleeding (P = .08) were observed in patients with cancer. CONCLUSIONS: The "real world" effectiveness and safety of rivaroxaban is similar for venous thromboembolism patients with and without active malignancy.
