What is the role of rivaroxaban (Xarelto) in the initial anticoagulation therapy for deep venous thrombosis (DVT)?

Updated: Nov 09, 2018
  • Author: Donald Schreiber, MD, CM; Chief Editor: Barry E Brenner, MD, PhD, FACEP  more...
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Answer

Answer

Rivaroxaban (Xarelto) is an oral factor Xa inhibitor approved by the FDA in November 2012 for treatment of DVT or PE and for reduction of the risk of recurrent DVT and PE after initial treatment. [12, 13] Approval for this indication was based on studies totaling 9478 patients with DVT or PE. Participants were randomly assigned to receive rivaroxaban, a combination of enoxaparin and a VKA (eg, warfarin), or a placebo. Study endpoints were designed to measure the number of patients who experienced recurrent symptoms of DVT, PE, or death after receiving treatment.

Data from a pooled analysis of the EINSTEIN-DV [12] and EINSTEIN-PE [13] trials suggested that use of rivaroxaban is as effective in preventing venous thromboembolism (VTE) recurrence as administering enoxaparin followed by a VKA, and it may be associated with less bleeding; in addition, the data suggested that there are no grounds for avoiding rivaroxaban use in high-risk groups (eg, fragile patients, cancer patients, and patients with a large clot).

Approximately 2.1% of patients treated with rivaroxaban experienced recurrent DVT or PE, compared with 1.8-3% treated with the enoxaparin and VKA combination. [12, 13]  In addition, results from extended treatment demonstrated a reduced risk of recurrent DVT and PE. Approximately 1.3% in the rivaroxaban group experienced recurrent DVT or PE, compared with 7.1% in the placebo group. [14, 15]


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