Results of the Phase III EINSTEIN-DVT study show that the oral anticoagulant rivaroxaban achieved the primary efficacy and safety outcomes in the treatment of patients with acute, symptomatic deep vein thrombosis (DVT). The Phase study was presented during a Hotline session at the European Society of Cardiology Congress 2010.

The study showed that rivaroxaban demonstrated non-inferior efficacy in the treatment of DVT compared with initial enoxaparin treatment followed by a vitamin K antagonist (VKA), the current standard therapy for the treatment of DVT. Recurrent symptomatic venous thromboembolism (i.e., the composite of recurrent DVT, non-fatal or fatal pulmonary embolism) occurred in 2.1% of the rivaroxaban recipients and 3.0% of the subjects receiving standard therapy (p<0.0001 for non-inferiority).

The EINSTEIN-DVT study also demonstrated similar rates of major and clinically relevant non-major bleeding, the principal safety outcome, for rivaroxaban compared with the current standard therapy (8.1% vs. 8.1%, respectively). No liver signal attributable to rivaroxaban was observed in the study.

"The results of the EINSTEIN-DVT trial indicate that rivaroxaban is an effective and safe treatment for acute symptomatic DVT," said principal investigator, Professor Harry R. Büller, Academic Medical Center, Amsterdam, the Netherlands. "The single-drug approach with rivaroxaban will provide clinicians and patients with an attractive, simple, alternative regimen for the initial and long-term treatment of deep vein thrombosis."

The multinational EINSTEIN-DVT study was designed to investigate a new single-drug approach with rivaroxaban in comparison to standard therapy in a randomized, open-label, non-inferiority study. The trial involved more than 3,400 patients with acute symptomatic DVT, but without any symptoms of pulmonary embolism, across 253 sites in 32 countries worldwide. Patients received either oral rivaroxaban (15 mg twice-daily for the first three weeks, followed by 20 mg once daily) or body weight-adjusted subcutaneous enoxaparin followed by warfarin or acenocoumarol (dose adjusted to maintain a therapeutic normalized ratio) for three, six or 12 months, based on the attending physician's assessment at baseline.

The primary efficacy outcome was the cumulative incidence of symptomatic recurrent venous thromboembolism (non-fatal or fatal). The principal safety outcome was the composite of major and clinically relevant non-major bleeding.

The EINSTEIN-DVT trial was also considered an important study, mainly because the oral factor Xa inhibitor rivaroxaban removes many of the drawbacks associated with standard therapy (subcutaneous injections, warfarin) for the treatment of deep vein thrombosis.

The EINSTEIN DVT study was sponsored by Bayer Schering Pharma.