EINSTEIN-DVT: Rivaroxaban Meets Primary End Point in VTE Trial

August 04, 2010

August 4, 2010 (Leverkusen, Germany) — The use of rivaroxaban (Xarelto, Bayer/Johnson & Johnson) is noninferior to standard medical therapy for reducing the cumulative incidence of symptomatic recurrent venous thromboembolism (VTE) [1].

The findings, from the EINSTEIN-DVT study, were announced today by Bayer, the maker of the new factor Xa inhibitor (marketed in collaboration with Johnson & Johnson), which stated in a press release that the drug met its primary end point. The trial began in 2007, enrolled approximately 3400 patients, and was expected to be completed in 2011.

Of the patients enrolled in the study, half were randomized to rivaroxaban 20 mg and half to enoxaparin 1.0 mg/kg twice daily for a minimal duration of five days followed by treatment with a vitamin-K antagonist. The primary end point was the recurrence of symptomatic VTE. Secondary outcome measures included clinically relevant bleeding, including major bleeding, and deaths and vascular events.

In its press release, Bayer stated that treatment with rivaroxaban resulted in an improved net clinical benefit, a composite of the primary efficacy end point plus major bleeding.

Results from the EINSTEIN-DVT trial were already scheduled to be presented by lead investigator Dr Harry Buller (Academic Medical Center, Amsterdam, the Netherlands) on August 31, at the European Society of Cardiology 2010 Congress in Stockholm, Sweden. In addition to data from EINSTEIN-DVT, Dr Stuart Connolly (McMaster University, Hamilton, ON) will present data from the AVERROES trial, a study comparing apixaban (Bristol-Myers Squibb/Pfizer) vs aspirin for the prevention of stroke in patients with atrial fibrillation who are unable to take warfarin. That presentation is also scheduled for August 31, 2010, right before EINSTEIN-DVT hits the stage. An atrial-fibrillation study with rivaroxaban is currently ongoing.

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