What is the role of rivaroxaban in the treatment of venous thromboembolism (VTE)?

Updated: Nov 05, 2020
  • Author: Vera A De Palo, MD, MBA, FCCP; Chief Editor: Vinod K Panchbhavi, MD, FACS, FAOA, FABOS, FAAOS  more...
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Rivaroxaban, an oral factor Xa inhibitor, is approved by the US Food and Drug Administration (FDA) for a variety of treatment and prophylaxis VTE indications, including the following:

  • Risk reduction for stroke and systemic embolism in nonvalvular atrial fibrillation
  • Treatment of DVT
  • Treatment of PE
  • Reduction in risk of recurrent DVT and/or PE
  • Prophylaxis of DVT following hip or knee replacement surgery
  • Prophylaxis of VTE in acutely ill medical patients at risk for thromboembolic complications owing to restricted mobility (and who are not at high risk of bleeding)
  • Risk reduction of major cardiovascular events with coronary artery disease (CAD) or peripheral artery disease (PAD)

In November 2012, rivaroxaban was approved by the FDA for the treatment of DVT or PE and for reduction of the risk of recurrent DVT and PE following initial treatment. [37, 38, 39, 40]

In October 2017, the FDA approved rivaroxaban in a dosage of 10 mg once daily for reducing the ongoing risk of recurrent VTE after at least 6 months of initial anticoagulation therapy. [41] In the new prescribing information, the drug may be initiated at 15 mg twice daily for the first 21 days after VTE, then reduced to 20 mg once daily from day 22 through at least day 180. After at least 180 days, the once-daily 10-mg regimen may now be prescribed for patients at continued risk for VTE.

In October 2019, rivaroxaban was approved for prophylaxis of VTE in acutely ill medical patients who are at risk for thromboembolic complications owing to restricted mobility (and who are not at high risk of bleeding). Rivaroxaban in this setting demonstrated noninferiority to enoxaparin with short-term use (10 ± 4 days) and superiority with long-term use (35 ± 4 days) compared with short-term use of enoxaparin followed by placebo. [42]

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. [43]

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