At-home rivaroxaban feasible for low-risk acute PE
Patients with acute, low-risk pulmonary embolism (PE) can be safely discharged within 2 days of hospitalization and treated with rivaroxaban out-of-hospital with a low incidence of recurrence, findings of the HoT-PE* study showed.
The study was an international, single-arm, phase IV trial. From a total of 2,854 patients with acute PE confirmed within 24 hours of hospital admission, 525 adults (mean age 56.7 years, 45.7 percent female, 98.5 percent Caucasian) formed the primary intention-to-treat (ITT) analysis. They received their first dose of rivaroxaban in hospital and were discharged within 48 hours of admission (median duration of hospitalization, 34 hours).
Individuals with right ventricular (RV) dysfunction and with free-floating thrombi in the heart, as confirmed by echocardiogram or CT scan, were excluded. This exclusion was due to a recent meta-analysis that demonstrated an elevated risk for early mortality (odds ratio, 4.19) among patients with PE who had RV dysfunction despite being considered low risk based on clinical criteria. [Eur Heart J 2019;40:902-910]
The 519 patients who formed the safety population received rivaroxaban 15 mg BID initially for a mean 21 days and 20 mg QD as maintenance for a mean 68 days. Patients were followed up for 3 months and 1-year follow up is ongoing.
Just three patients (0.6 percent) experienced recurrent symptomatic venous thromboembolism (VTE) or fatal PE in the ITT population, all of which were recurrent PE with no incidence of recurrent deep vein thrombosis or PE-related deaths. [ACC.19, abstract 402-16]
Six patients (1.2 percent) experienced major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH) criteria (three with uterine, two with gastrointestinal, and one with intracranial bleeding), while 31 patients experienced clinically relevant bleeding. Fifty-eight patients experienced at least one serious adverse event.
Twelve patients were re-admitted to hospital due to suspected recurrent PE or bleeding. Of these, the actual diagnoses were pneumonia (n=4), major bleeding (n=4), recurrent PE (n=2), clinically relevant non-major bleeding (n=1), and other causes (n=1).
The two deaths that occurred within 3 months were due to advanced cancer.
“[D]irect oral anticoagulants have simplified the initial phase of anticoagulation and the transition … from parenteral to oral treatments so we now have a single oral strategy,” said study author Professor Stavros V. Konstantinides from the Johannes Gutenberg University of Mainz, Mainz, Germany, who presented the results at ACC.19.
“In patients with acute low-risk PE [including absence of RV dysfunction and intracardiac thrombi], early discharge and home treatment with rivaroxaban was effective, safe, and feasible,” said Konstantinides.
“The results of HoT-PE support the selection of appropriate PE patients for ambulatory treatment with a direct oral anticoagulant, helping to reduce hospital-related complications and rationalize the use of healthcare resources,” he said.