Abstract
The EINSTEIN-DVT study is an open-label, randomized study comparing oral rivaroxaban with subcutaneous enoxaparin, followed by warfarin for three six or twelve months in patients with acute symptomatic deep vein thrombosis. Selected patients continued rivaroxaban therapy or placebo for additional six to twelve months after the EINSTEIN-DVT study had ended (EINSTEIN-EXT study).
The EINSTEINN-DV study proved rivoraxaban to be as effective as the standard therapy with similar bleeding risk. Morover, rivaroxaban therapy could be started without LMWH pretreatment.
When extended by additional six or twelve months, rivoraxaban therapy is highly effective in the prevention of DVT recurrence and is associated with an acceptable bleeding risk compared to placebo. The study did not prove rivaroxaban to be hepatotoxic.