Efficacy and Safety of Rivaroxaban in Patients with Venous Thromboembolism and Active Malignancy: A Single-center Registry

• Published in: The American journal of medicine Vol. 129; no. 6; pp. 615 - 619
• Main Authors: Bott-Kitslaar, Dalene M., APRN, CNP, Saadiq, Rayya A., DO, McBane, Robert D., MD, Loprinzi, Charles L., MD, Ashrani, Aneel A., MD, Ransone, Teresa R., PA-C, Wolfgram, Alissa A., RN, Berentsen, Michelle M., RN, Wysokinski, Waldemar E., MD
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.06.2016; Elsevier Sequoia S.A
• Subjects: Aged; Anticoagulants; Case-Control Studies; Comorbidity; Direct oral anticoagulants; Factor Xa Inhibitors - adverse effects; Factor Xa Inhibitors - therapeutic use; Female; Hemorrhage - chemically induced; Hemorrhage - epidemiology; Humans; Internal Medicine; Male; Malignancy; Medical treatment; Middle Aged; Neoplasms - complications; Neoplasms - drug therapy; Patient Safety; Prospective Studies; Recurrence; Registries; Risk Assessment; Rivaroxaban - adverse effects; Rivaroxaban - therapeutic use; Rivaroxaban venous thromboembolism; Thromboembolism; Venous Thromboembolism - drug therapy; Venous Thromboembolism - etiology; Rivaroxaban venous thromboembolism; Direct oral anticoagulants; Malignancy
• ISSN: 0002-9343; 1555-7162
• DOI: 10.1016/j.amjmed.2015.12.025

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.