Treatment of VTE in Primary Care: Building a New Approach to Patient Management With Rivaroxaban

Rosie Heath

Disclosures

Br J Cardiol. 2015;22(2):1-3. 

In This Article

Abstract and Introduction

Abstract

Venous thromboembolism (VTE) is a common cardiovascular disorder associated with considerable morbidity and mortality. The standard treatment for VTE comprises parenteral heparin overlapping with, and followed by, a vitamin K antagonist, which, although effective, has several limitations. Currently, many patients commence treatment for VTE in hospital and are discharged after 5–10 days to ongoing care in the community. With the introduction of non-vitamin K oral anticoagulants (NOACs), there is now the possibility for the complete management of patients with uncomplicated VTE to be undertaken by primary care, reducing the burden on hospitals and improving the patient experience. The NOAC rivaroxaban, a direct factor Xa inhibitor, has been widely approved for the treatment of VTE. This article offers guidance to general practitioners on the practical use of rivaroxaban for the treatment of patients with VTE, along with a discussion of its potential benefits compared with standard therapy.

Introduction

Venous thromboembolism (VTE), comprising deep vein thrombosis (DVT) and pulmonary embolism (PE), causes considerable morbidity and mortality.[1] VTE is associated with 370,000 deaths per year in the European Union (EU), an estimated 12% of annual deaths.[1] The average incidence of VTE in Europe is approximately 160–180 per 100,000 person-years.[1]

Three large phase III trials with rivaroxaban, a direct factor Xa inhibitor approved for the treatment and prevention of VTE, have provided a strong safety and efficacy evidence base ( Table 1 ). The EINSTEIN-DVT study compared rivaroxaban (15 mg twice daily for 21 days, followed by 20 mg once daily) with the low molecular weight heparin (LMWH) enoxaparin in combination with, and followed by, a vitamin K antagonist (VKA) for up to 12 months for the treatment of DVT in patients without PE.[2] The EINSTEIN-PE study compared rivaroxaban with enoxaparin/VKA for the treatment of PE in patients with or without DVT.[3] EINSTEIN-EXT involved patients from EINSTEIN-DVT and EINSTEIN-PE who had already received 6–12 months of anticoagulation and were randomised to receive rivaroxaban (20 mg once daily) or placebo for a further six or 12 months.[4] The primary efficacy end point for all three studies was symptomatic recurrent VTE (composite of DVT and non-fatal or fatal PE).[2,3] In EINSTEIN-DVT and EINSTEIN-PE, rivaroxaban was non-inferior to enoxaparin/VKA, with a similar incidence of clinically relevant non-major bleeding.[2,3] EINSTEIN-PE showed that rivaroxaban conferred a significant 51% relative-risk reduction in major bleeding ( Table 1 ), including reductions in intracranial haemorrhage and retroperitoneal bleeding.[3] In EINSTEIN-EXT, rivaroxaban demonstrated superior efficacy compared with placebo, with no significant difference in the incidence of major bleeding.[4]

The NOACs, dabigatran and apixaban, are also approved for VTE treatment, based on the data from phase III studies, and a phase III trial of edoxaban, approved in Japan and the US, has demonstrated positive outcomes.[5]

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