How effective is rivaroxaban (Xarelto) in the treatment of pulmonary embolism (PE)?

Updated: Sep 18, 2020
  • Author: Daniel R Ouellette, MD, FCCP; Chief Editor: Zab Mosenifar, MD, FACP, FCCP  more...
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Rivaroxaban (Xarelto) is an oral factor Xa inhibitor approved by the FDA in November 2012 for the treatment of DVT or PE, and to reduce risk of recurrent DVT and PE following initial treatment.

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 vitamin K antagonist (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. [88, 89] Additionally, 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. [90, 91]

The results of the Einstein-PE study provide an important advance in the treatment of symptomatic PE. In a prospective, open-label study, 4832 patients were randomized to receive either rivaroxaban or enoxaparin followed by an adjusted-dose vitamin K antagonist for 3, 6, or 12 months. Treatment with a fixed-dose regimen of rivaroxaban was noninferior to standard therapy and had a satisfactory safety profile. [88]

Data from a pooled analysis of the EINSTEIN-PE and EINSTEIN-DVT studies in the treatment of DVT or pulmonary embolism suggest that rivaroxaban is as effective in preventing VTE recurrence as administration of enoxaparin followed by a vitamin-K antagonist. [92, 93] Rivaroxaban may also be associated with less bleeding, particularly in elderly patients and those with moderate renal impairment. [92, 93]

Rivaroxaban use for VTE prevention in acutely ill medical patients with restricted mobility demonstrated noninferiority to enoxaparin in short-term use (10 ± 4 days) and superiority in long-term use (35 ± 4 days) compared with short-term use of enoxaparin followed by placebo. [94] Another study failed to show a significant benefit of rivaroxaban over placebo in reducing the composite end point of symptomatic VTE or death in medically ill patients at increased risk for VTE after discharge; however, there were few events and the primary safety outcome, major bleeding, was not significantly increased with treatment. [95]

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