Ambulatory patients receiving cancer therapy are at an increased risk of venous thromboembolism (VTE). Thromboprophylaxis is a chemical-mechanical combination therapy used for the prevention of clots formation in veins. The objective of this study is to assess the benefits of thromboprophylaxis in high-risk ambulatory patients with cancer.
This randomized, double-blind trial consisted of a total of 841 high-risk ambulatory patients with cancer and without deep-vein thrombosis. The patients were assigned in a 1:1 ratio to receive rivaroxaban (at a dose of 10 mg, [n=420]) or placebo (n=421) daily for up to 180 days. The primary outcome of the study was a composite of objectively confirmed proximal deep-vein thrombosis in the lower or upper limb.
During the assessment of up to 180 days, deep-vein thrombosis was confirmed in 25 of 420 patients (6.0%) in the rivaroxaban group and in 37 of 421 (8.8%) in the placebo group. Further analysis indicated that the primary endpoint occurred in 11 patients (2.6%) in the rivaroxaban group and in 27 (6.4%) in the placebo group. Major bleeding was reported in 8 patients (2.0%) in the rivaroxaban group and in 4 (1.0%) in the placebo group.
The findings suggested that treatment with rivaroxaban did not result in a lower incidence of venous thromboembolism in high-risk ambulatory patients with cancer.