Oral Anticoagulant is Noninferior to Standard Treatment for Cancer-Associated VTE
Oral edoxaban is noninferior to subcutaneous dalteparin for the treatment of recurrent venous thromboembolism (VTE) or major bleeding among patients with cancer, according to a recent study.
The current standard of care treatment for cancer-associated VTE is low-molecular-weight heparin. However, the role of treatment with direct oral anticoagulant agents is unknown.
Gary E Raskob, PhD, University of Oklahoma Health Sciences Center (Oklahoma City, OK), and colleagues evaluated 1050 patients with cancer with acute symptomatic or incidental VTE.
Patients were randomly assigned to receive either low-molecular-weight heparin for at least 5 days followed by once-daily 60 mg oral edoxaban (edoxaban group) or 200 IU per kilogram of body weight subcutaneous dalteparin once daily for 1 month followed by once-daily 150 IU per kilogram dalteparin (dalteparin group). Patients were treated for at least 6 months and for up to 12 months.
The primary outcome was defined as a composite of recurrent VTE or major bleeding in the 12 months following randomization, regardless of treatment duration. Results of the study were published in the New England Journal of Medicine (online December 12, 2017; doi:10.1056/NEJMoa1711948).
A total of 1046 patients were included in the modified intention-to-treat analysis. Results revealed that 67 (12.8%) of 522 patients in the edoxaban group experienced the primary outcome compared with 71 (13.5%) of 524 patients in the dalteparin group (HR, 0.97). Forty-one (7.9%) patients on edoxaban had recurrent VTE, compared with 59 (11.3%) on dalteparin, with a difference in risk of -3.4 percentage points.
Additionally, 36 (6.9%) patients on edoxaban experienced major bleeding vs 21 (4.0%) on dalteparin, with a difference in risk of 2.9 percentage points.
“Oral edoxaban was noninferior to subcutaneous dalteparin with respect to the composite outcome of recurrent venous thromboembolism or major bleeding,” the researcher concluded. “The rate of recurrent venous thromboembolism was lower but the rate of major bleeding was higher with edoxaban than with dalteparin.”—Christina Vogt