Risk for patients in rivaroxaban group reduced during the on-treatment period
WEDNESDAY, Dec. 5, 2018 (HealthDay News) — Rivaroxaban can prevent venous thromboembolism (VTE) in cancer patients at increased risk, according to a study presented at the annual meeting of the American Society of Hematology, held from Dec. 1 to 4 in San Diego.
Alok A. Khorana, M.D., from the Cleveland Clinic, and colleagues conducted a double-blind, randomized, multicenter study involving adult ambulatory patients with cancer who were initiating a new systemic regimen and were at increased risk for VTE. Participants were screened for deep-vein thrombosis (DVT) and were randomly assigned to rivaroxaban or placebo if no DVT was found. A total of 841 patients were randomized.
The researchers found that the primary efficacy end point (composite of asymptomatic or symptomatic lower-extremity proximal DVT, symptomatic upper- or lower-extremity distal DVT, symptomatic or incidental pulmonary embolism, and VTE-related death) occurred in 5.95 and 8.79 percent of patients in the rivaroxaban and placebo groups, respectively (hazard ratio, 0.66; 95 percent confidence interval, 0.40 to 1.09; P = 0.101) in the up-to-180-day observation period. Overall, 38.7 percent of patients with VTE experienced events after discontinuing the study drug. The primary end point occurred in 2.62 and 6.41 percent of patients in the rivaroxaban and placebo groups, respectively (hazard ratio, 0.40; 95 percent confidence interval, 0.20 to 0.80; P = 0.007) in a prespecified analysis of all randomly assigned patients during the on-treatment period.
“This signals a change in the prevention approaches to cancer-associated VTE,” Khorana said in a statement. “We are moving into a new era of direct oral anticoagulants.”
One author disclosed financial ties to pharmaceutical companies, including Bayer, which funded the study with Janssen, the manufacturer of rivaroxaban.
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