Study Shows Risks of Discontinuing Therapy in Venous Thromboembolism Patients
Patients with venous thromboembolism, which includes deep vein thrombosis and pulmonary embolism, are at risk for recurrence after discontinuing therapy, even if the event was unprovoked. The authors of a new study examined extended treatment for patients with venous thromboembolism, comparing low-dose aspirin to two different doses of rivaroxaban, a direct oral anticoagulant. In a randomized, double-blind, Phase III study, 3,396 patients with venous thromboembolism were assigned to receive either once-daily rivaroxaban (at doses of 20 mg or 10 mg) or 100 mg of aspirin. All patients had received six to 12 months of standard anticoagulation and were in equipoise regarding whether continued anticoagulation was needed. More than 3,300 patients were included in the intention-to-treat analysis, with a median treatment duration of just less than one year. The primary efficacy outcome was symptomatic recurrent fatal or nonfatal venous thromboembolism, and the principal safety outcome was major bleeding. The primary outcome occurred in 1.5% of patients receiving 20 mg of rivaroxaban, 1.2% receiving 10 mg rivaroxaban, and 4.4% receiving aspirin (P < 0.001 for both comparisons). Rates of major bleeding were 0.5% in the group receiving 20 mg of rivaroxaban, 0.4% for 10 mg of rivaroxaban, and 0.3% in the aspirin group. Non-clinically relevant bleeding was 2.7%, 2.0%, and 1.8%, respectively. The rate of adverse events was similar in all groups. The authors concluded that “among patients with venous thromboembolism in equipoise for continued anticoagulation, the risk of a recurrent event was significantly lower with rivaroxaban at either a treatment dose (20 mg) or a prophylactic dose (10 mg) than with aspirin, without a significant increase in bleeding rate.” (N Engl J Med 2017;376:1211-1222)
Patients with venous thromboembolism, which includes deep vein thrombosis and pulmonary embolism, are at risk for recurrence after discontinuing therapy, even if the event was unprovoked.
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