Early discharge and home treatment with rivaroxaban is effective and safe in carefully selected patients with acute low-risk pulmonary embolism (PE), suggest interim findings from the Home Treatment of Patients with Low-Risk Pulmonary Embolism with the Oral Factor Xa Inhibitor Rivaroxaban (HoT-PE) trial.
The prospective multicentre single-arm study enrolled consecutive patients with acute low-risk PE from seven countries between May 2014 and June 2018. Eligibility criteria included absence of (i) haemodynamic instability, (ii) right ventricular (RV) dysfunction or intracardiac thrombi and (iii) serious comorbidities. Rivaroxaban was given at the approved dose for PE for at least three months.
The primary outcome was symptomatic recurrent venous thromboembolism (VTE) or PE-related death within three 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=.004 (<6 primary outcome events).
In the interim analysis, three of the 525 patients suffered symptomatic non-fatal VTE recurrence (0.6%; one-sided upper 99.6% confidence interval 2.1%). The number was sufficiently low to fulfil the condition for early termination of the trial.
The authors concluded that early discharge and ambulatory treatment with the oral factor Xa inhibitor is effective and safe in patients with acute low-risk PE selected on the basis of clinical criteria as well as the absence of RV dysfunction on admission.
They say the present trial may have a clinically relevant impact on the selection of PE patients for early discharge and ambulatory management, helping to reduce in-hospital complications and rationalise the use of healthcare resources.
