Early discharge and home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxaban: an international multicentre single-arm clinical trial

Abstract

Aims To investigate the efficacy and safety of early transition from hospital to ambulatory treatment in low-risk acute PE, using the oral factor Xa inhibitor rivaroxaban. Methods and results We conducted a prospective multicentre single-arm investigator initiated and academically sponsored management trial in patients with acute low-risk PE (EudraCT Identifier 2013-001657-28). Eligibility criteria included absence of (i) haemodynamic instability, (ii) right ventricular dysfunction or intracardiac thrombi, and (iii) serious comorbidities. Up to two nights of hospital stay were permitted. Rivaroxaban was given at the approved dose for PE for ≥3 months. The primary outcome was symptomatic recurrent venous thromboembolism (VTE) or PE-related death within 3 months of enrolment. An interim analysis was planned after the first 525 patients, with prespecified early termination of the study if the null hypothesis could be rejected at the level of α = 0.004 (<6 primary outcome events). From May 2014 through June 2018, consecutive patients were enrolled in seven countries. Of the 525 patients included in the interim analysis, three (0.6%; one-sided upper 99.6% confidence interval 2.1%) suffered symptomatic non-fatal VTE recurrence, a number sufficiently low to fulfil the condition for early termination of the trial. Major bleeding occurred in 6 (1.2%) of the 519 patients comprising the safety population. There were two cancer-related deaths (0.4%). Conclusion Early discharge and home treatment with rivaroxaban is effective and safe in carefully selected patients with acute low-risk PE. The results of the present trial support the selection of appropriate patients for ambulatory treatment of PE.

2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS)

“…Major bleeding occurred in six (1.2%) of the patients in the safety population. There were no PE-related deaths [319]. In view of the existing evidence-and taking into consideration (i) the catastrophic scenario of early death if a patient with acute PE is falsely judged to be at low risk on clinical grounds alone and discharged "too early" (as described in a prematurely terminated trial [328]), and (ii) the ease and minimal additional effort of assessing RV size and function at presentation by echocardiography, or on the CTPA performed to diagnose the PE event itself [329] (section 5)-it is wise to exclude RV dysfunction and right heart thrombi if immediate or early (within the first 24-48 h) discharge of the patient is planned.…”

“…Carefully selected patients with low-risk PE should be considered for early discharge and continuation of treatment at home, if proper outpatient care and anticoagulant treatment can be provided c [178,206,[317][318][319].…”

COVID-19 and Thrombotic or Thromboembolic Disease: Implications for Prevention, Antithrombotic Therapy, and Follow-Up

“…The main goal of management for patients with known or new-onset thrombotic disease but without COVID-19 is to provide sufficient antithrombotic protection, while minimizing physical contact between patients and healthcare workers and health systems. Outpatient management or early discharge for acute VTE should be instituted when possible (120)(121)(122), and early discharge after medication stabilization for low-risk ACS or PCI for high-risk ACS should be considered (100)(101)(102). Telemedicine should be the preferred method of follow-up, and inperson visits should be reserved only for scenarios that cannot be addressed by telemedicine, or that may potentially warrant hospitalization.…”

Home vs hospital treatment of low-risk venous thromboembolism: a systematic review and meta-analysis

“…Major bleeding occurred in 6 of the 519 patients (1.2%) comprising the safety population suggesting that early discharge and home treatment with rivaroxaban is effective and safe in carefully selected patients with low-risk PE. 30…”