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
Key result
Early home rivaroxaban for low-risk PE yields a 0.6% recurrent VTE or PE-related death rate.
- upper 99.6% CI 2.1
- n=525
Why the study?
The study was conducted to investigate the efficacy and safety of early transition from hospital to ambulatory treatment using oral rivaroxaban in patients with low-risk acute pulmonary embolism.
Does early discharge and home treatment with rivaroxaban prevent recurrent VTE or PE-related death in patients with low-risk acute PE?
Population
525 patients with acute low-risk PE
Comparison
Early discharge and ambulatory treatment with rivaroxaban for ≥3 months
Design
Prospective international multicentre single-arm management trial
Follow-up
3 months
Authors
Discussion
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Member takes
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“The main objective of the HoT-PE trial was to determine whether early discharge and out-of-hospital treatment with rivaroxaban with patients with acute low-risk PE — with an emphasis on selected patients — would be effective, safe and, indirectly, feasible.”
“We applaud Barco et al. for their multicentre single-arm management trial of 525 adults with acute low-risk pulmonary embolism who were directed to outpatient care on rivaroxaban after no more than two nights hospitalization. The low incidence of 3-month adverse events in the HoT-PE trial demonstrates the safety and effectiveness of their patient selection criteria and adds to the growing evidence supporting an early transition to ambulatory care either directly from the emergency department or after a short hospital stay.”
“The present analysis of the full cohort of 576 did not change the conclusions from those made on the basis of the previously published 525 patients, that an early discharge strategy is effective and safe for low-risk PE patients.”
Implication
Supports early home treatment with rivaroxaban in selected low-risk PE; leaves open need for randomized trials before practice change.
Key Points
- To evaluate the efficacy and safety of early hospital discharge and ambulatory treatment using the oral factor Xa inhibitor rivaroxaban in patients with acute low-risk pulmonary embolism.
- Conducted a prospective, multicentre, single-arm management clinical trial (EudraCT 2013-001657-28) across seven countries among patients with acute low-risk pulmonary embolism who had no hemodynamic instability, right ventricular dysfunction, or serious comorbidities.
- Patients were discharged within two nights and treated with approved doses of oral rivaroxaban for 3 months or longer, with a planned interim analysis after 525 patients evaluating symptomatic recurrent venous thromboembolism or pulmonary embolism-related death.
- In the interim analysis cohort (N=525), symptomatic non-fatal venous thromboembolism recurrence occurred in 3 patients (0.6%; one-sided upper 99.6% CI 2.1%), fulfilling predefined criteria for early trial termination.
- Among the safety population (N=519), major bleeding occurred in 6 patients (1.2%), and 2 cancer-related deaths (0.4%) were reported during the 3-month follow-up.
Structured PICO
Does early discharge and home treatment with rivaroxaban prevent recurrent VTE or PE-related death in patients with low-risk acute PE?
P
Population
525 patients with acute low-risk pulmonary embolism, without haemodynamic instability or serious comorbidities, treated with rivaroxaban and followed for 3 months.
I
Intervention
Early discharge (up to two nights hospital stay) and home treatment with oral rivaroxaban at the approved dose for PE for ≥3 months
O
Outcome
Symptomatic recurrent venous thromboembolism (VTE) or PE-related death within 3 months of enrolmentcomposite
Early discharge and home treatment with rivaroxaban is effective and safe in carefully selected patients with acute low-risk pulmonary embolism.
Cite This Study
Barco et al. (2019) studied acute low-risk pulmonary embolism (n=525). Rivaroxaban was evaluated on symptomatic recurrent venous thromboembolism (VTE) or PE-related death within 3 months of enrolment (95% CI upper 99.6% CI 2.1). Early discharge and home treatment with rivaroxaban in patients with acute low-risk pulmonary embolism resulted in a 0.6% rate of symptomatic recurrent VTE or PE-related death at 3 months.