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Rivaroxaban reduced incidence of DVT, major bleeding risk
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52nd ASH Annual Meeting
ORLANDO — Results from the Einstein-DVT study showed that oral rivaroxaban was superior to enoxaparin and vitamin K agonist for the treatment of deep vein thrombosis. Similarly, results from the Einstein-Extension study showed that rivaroxaban reduced the risk for major bleeding compared with placebo.
“This regimen of rivaroxaban 15 mg twice a day for the first 3 weeks, followed by 20 mg for the remainder period, provides clinicians and patients with an attractive and simple treatment for venous thromboembolism, not only in the acute setting, but also when prolonged treatment is necessary,” said Harry R. Büller, MD, PhD, professor of medicine at the Academic Medical Center at the University of Amsterdam.
Büller discussed the results during a press conference Saturday during the 52nd American Society of Hematology Annual Meeting.
In the Einstein-DVT study, patients with acute DVT without symptomatic pulmonary embolism were randomly assigned to twice-daily 15 mg rivaroxaban followed by 20 mg daily rivaroxaban (n=1,731), a direct oral factor Xa inhibitor, or enoxaparin and oral vitamin K antagonist (n=1,718) for 3, 6, or 12 months.
There were 36 DVT events in the rivaroxaban group vs. 51 events in the enoxaparin/vitamin K agonist group (HR=0.68; 95% CI, 0.44-1.04).
“The conclusion from a statistical point of view is a very clear result of non-inferiority,” Büller said. “In actual fact, it’s pretty close to showing superiority.”
Major and non-major clinically relevant bleeding occurred in 8.1% of both treatment groups. There were 14 major bleeding events, one of which was fatal, in the rivaroxaban group and 20 major bleeding events (1.2%) with five deaths in the enoxaparin/vitamin K agonist group (HR=0.65; 95% CI, 0.33-0.28).
HR=0.67 for net clinical benefit, which was defined as the primary efficacy outcome plus major bleeding, (95% CI, 0.47-0.95). There were 38 deaths (2.2%) in the rivaroxaban group compared with 49 (2.9%) in the enoxaparin/ vitamin K agonist group (HR=0.67; 95% CI 0.44-1.02).
There were 38 deaths in the rivaroxaban group and 49 in the enoxaparin/ vitamin K agonist group.
The Einstein-Extension was a randomized, double-blind, placebo-controlled, superiority study. Patients who had completed 6 to 12 months of anticoagulant treatment for either DVT or pulmonary embolism were randomly assigned to 20 mg daily rivaroxaban (n=602) or placebo (n=594) for an additional 6 or 12 months.
Büller said there were eight events in the rivaroxaban group vs. 42 events in the placebo group (HR=0.18; 95% CI, 0.09-0.39).
There were no cases of major bleeding in the placebo group compared with four, non-fatal incidents in the rivaroxaban group (P=.11). Seven patients (1.2%) in the placebo group and 32 (5.4%) patients in the rivaroxaban group had clinically relevant non-major bleeding.
Büller added that efficacy and safety results were consistent across all pre-specified subgroups in both studies. – by Jason Harris
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