Background: The simplified PE Severity Index (sPESI) is one of several validated prognostic tools for acute pulmonary embolism (PE). The European Society of Cardiology recommended the use of the sPESI to risk-stratify patients with acute PE into low risk (sPESI=0) and non-low risk (sPESI≥1) in order to guide treatment and disposition (Konstantinides 2014). Systematic reviews and meta-analyses have found that outpatient management of low-risk PE patients with standard therapy is safe, effective, and cost-effective (Aujesky 2011, Zondag 2013, Kahler 2015).
Standard practice in the United States for treatment of acute PE over the last decade has been a parenteral agent (e.g. enoxaparin, fondaparinux) overlapping with a vitamin K antagonist (VKA) (e.g. warfarin). However, a paradigm shift has been brewing over recent years. Direct oral anticoagulants (DOACs) have demonstrated efficacy as initial and long-term treatment of PE compared to standard therapy in various trials (EINSTEIN-PE 2012, RE-COVER 2014, AMPLIFY 2013, Hosukai-VTE 2013). The EINSTEIN-PE study found that rivaroxaban was noninferior to enoxaparin/VKA for the treatment of recurrent venous thromboembolism (VTE) without increased risk of bleeding. Rivaroxaban and other DOACs are approved for treatment of VTE in the European Union, but use in the United States of DOACs for ED treatment of PE is more limited. Read more →