Why the study?
Outpatient treatment protocols exist for DVT, but no large-scale study has evaluated a comprehensive protocol using monotherapy anticoagulation to treat both DVT and PE from the emergency department.
Does expedited home treatment with apixaban or rivaroxaban prevent recurrent VTE and bleeding requiring hospitalization in low-risk emergency department patients with venous thromboembolism?
Does expedited home treatment with apixaban or rivaroxaban prevent recurrent VTE and bleeding requiring hospitalization in low-risk emergency department patients with venous thromboembolism?
This study protocol establishes a structured framework to prospectively evaluate the safety and efficacy of direct emergency department discharge for low-risk VTE patients treated with direct-acting oral anticoagulants.
INTRODUCTION: In the USA, many emergency departments (EDs) have established protocols to treat patients with newly diagnosed deep vein thrombosis (DVT) as outpatients. Similar treatment of patients with pulmonary embolism (PE) has been proposed, but no large-scale study has been published to evaluate a comprehensive, integrated protocol that employs monotherapy anticoagulation to treat patients diagnosed with DVT and PE in the ED. METHODS AND ANALYSIS: This protocol describes the implementation of the Monotherapy Anticoagulation To expedite Home treatment of Venous ThromboEmbolism (MATH-VTE) study at 33 hospitals in the USA. The study was designed and executed to meet the requirements for the Standards for Reporting Implementation Studies guideline. The study was funded by investigator-initiated awards from industry, with Indiana University as the sponsor. The study principal investigator and study associates travelled to each site to provide on-site training. The protocol identically screens patients with both DVT or PE to determine low risk of death using either the modified Hestia criteria or physician judgement plus a negative result from the simplified PE severity index. Patients must be discharged from the ED within 24 hours of triage and treated with either apixaban or rivaroxaban. Overall effectiveness is based upon the primary efficacy and safety outcomes of recurrent VTE and bleeding requiring hospitalisation respectively. Target enrolment of 1300 patients was estimated with efficacy success defined as the upper limit of the 95% CI for the 30-day frequency of VTE recurrence below 2.0%. Thirty-three hospitals in 17 states were initiated in 2016-2017. ETHICS AND DISSEMINATION: All sites had Institutional Review Board approval. We anticipate completion of enrolment in June 2020; study data will be available after peer-reviewed publication. MATH-VTE will provide information from a large multicentre sample of US patients about the efficacy and safety of home treatment of VTE with monotherapy anticoagulation.
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Kline et al. (2020) studied Venous thromboembolism (deep vein thrombosis and pulmonary embolism) (n=1,300). Apixaban or rivaroxaban was evaluated on Recurrent VTE requiring hospitalization within 30 days.
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