December 4th, 2010
Rivaroxaban Found Safe and Effective for DVT
Larry Husten, PHD
In the EINSTEIN-DVT noninferiority study, 3449 patients with acute DVT were randomized to receive open label oral rivaroxaban or conventional therapy with enoxaparin followed by warfarin or acenocoumarol for 3, 6, or 12 months. The rate of recurrent VTE, the primary efficacy outcome, was lower with rivaroxaban treatment than with enoxaparin treatment, successfully demonstrating noninferiority for rivaroxaban. The rate of major and clinically relevant non-major bleeding, the primary safety outcome, was the same in both groups.
Here are the main results (rivaroxban versus conventional therapy):
- Recurrent VTE: 2.1% versus 3.0% (HR, 0.68; CI, 0.44 – 1.04; p<0.001)
- Major and clinically relevant non-major bleeding: 8.1% in each group
- Net clinical benefit (the composite of the primary efficacy outcome plus major bleeding): 2.9% vs. 4.2% (HR, 0.67; CI, 0.47 – 0.95)
- All-cause mortality: 2.2% vs. 2.9% (HR, 0.67; CI, 0.44 – 1.02)
In the EINSTEIN-Extension double-blind superiority study, 1196 patients who had completed the EINSTEIN-DVT study (or the similar EINSTEIN-PE study, which enrolled patients with acute pulmonary embolism) and had therefore received anticoagulant therapy for 6 or 12 months, were randomized to receive rivaroxaban or placebo for an additional 6 or 12 months. The rate of recurrent VTE was significantly lowered by rivaroxaban treatment, with a rate of 7.1% in the placebo group compared to 1.3% in the rivaroxaban group (HR, 0.18; CI, 0.09 – 0.39; p<0.001). There were four nonfatal major bleeds in the rivaroxban group, compared to none in the placebo group.
The EINSTEIN investigators concluded that rivaroxaban “may provide an effective, safe, single-drug approach to the initial and continued treatment of venous thrombosis.”
EINSTEIN-DVT and EINSTEIN-Extension were presented at the American Society of Hematology meeting and published simultaneously in the New England Journal of Medicine. The results of EINSTEIN-DVT were presented earlier this year in August at the ESC.
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