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THURSDAY, Feb. 21, 2019 (HealthDay News) — In high-risk ambulatory patients with cancer, the incidence of venous thromboembolism or death due to venous thromboembolism during 180 days is not significantly reduced for rivaroxaban compared with placebo, according to a study published in the Feb. 21 issue of the New England Journal of Medicine<\/i>.<\/p>\n
Alok A. Khorana, M.D., from the Taussig Cancer Institute in Cleveland, and colleagues conducted a randomized trial involving high-risk ambulatory patients with cancer (Khorana score of \u22652) and without deep vein thrombosis at screening who received rivaroxaban or placebo daily for up to 180 days. A total of 841 patients underwent random assignment.<\/p>\n
The researchers found that the primary end point (composite of objectively confirmed proximal deep vein thrombosis in a lower limb, pulmonary embolism, symptomatic deep vein thrombosis in an upper limb or distal deep vein thrombosis in a lower limb, and death from venous thromboembolism) occurred in 6 and 8.8 percent of patients in the rivaroxaban and placebo groups, respectively (hazard ratio, 0.66; 95 percent confidence interval, 0.4 to 1.09; P = 0.1) in the period up to day 180. The primary end point occurred in 2.6 and 6.4 percent of patients in the rivaroxaban and placebo groups, respectively, in the prespecified intervention-period analysis (hazard ratio, 0.4; 95 percent confidence interval, 0.2 to 0.8).<\/p>\n
“In this placebo-controlled trial, we did not establish the benefit of treatment with rivaroxaban, because the between-group difference in the prespecified primary efficacy end point up to day 180 was not significant,” the authors write.<\/p>\n
The study was partially funded by Janssen, the manufacturer of rivaroxaban, and Bayer.<\/p>\n
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