Immediate discharge for low-risk PE feasible with rivaroxaban

An early discharge strategy with rivaroxaban reduces hospital lengths of stay and healthcare costs for patients with low-risk pulmonary embolism (LRPE)—without compromising their safety—suggests a study published in Academic Emergency Medicine.

“Because anticoagulation onset occurs within two hours of oral administration, rivaroxaban could obviate the historical requirement for bridging therapy with a parenteral anticoagulant agent,” wrote the researchers, led by W. Frank Peacock, MD, associate chair and research director of the emergency medicine department at Baylor College of Medicine in Houston.

“As this strategy questions the necessity for hospitalization to simply take an oral medication, we performed the first U.S. study randomizing ED LRPE patients to hospital discharge on an oral factor Xa inhibitor (rivaroxaban) versus standard‐of‐care (SOC) therapy.”

Ninety-nine patients completed 90 days of follow-up for the study, which randomized patients 1:1 to the two strategies. Low-risk was defined as the absence of Hestia criteria, a list containing risk-boosting factors such as pregnancy, PE diagnosed while on anticoagulants, the need for thrombectomy or IV pain medication or a concurrent medical or social reason for admission.

There were no cases of recurrent venous thromboembolism or death in either group at three months of follow-up, and bleeding events were similarly low in both treatment arms. However, patients in the rivaroxaban early discharge group spent an average of 19.2 hours in the hospital—including the initial visit and follow-up over 90 days—versus 43.2 hours in the SOC group. Total costs were a median $2,496 lower for the rivaroxaban intervention. The researchers pointed out shorter hospital stays also lower the risk for hospital-acquired conditions and infections.

“Our primary endpoint demonstrates that the prospective identification of LRPE patients in the ED is feasible, can result in much shorter hospitalization exposure, and markedly decreases costs without a negative impact on patient satisfaction and with no increase in VTE or bleeding events,” Peacock and colleagues wrote. “While our small sample size limits safety statements, very large studies (n > 3,500) have previously and definitively established that there are very low rates of bleeding and recurrent VTE events.”

Patients in the rivaroxaban group were discharged within 24 hours of triage in the emergency department and told to take 15 mg of the medication twice daily for three weeks, and then 20 mg once daily until study completion. Standard-of-care patients were treated per local protocol.

Interestingly, half of them received rivaroxaban anyway and another quarter received apixaban, another non-vitamin K antagonist oral anticoagulant (NOAC).

“Some may consider the fact that 75 percent of our control group were discharged on a NOAC as a limitation and that randomization alone may have contributed to our between-group differences,” the authors wrote. “We would point out that this reflects current ED practice patterns of hospitalization on an intravenous anticoagulant, then followed by discharge on a NOAC. It should be clear from this analysis that, in selected patients, ED admission for a limited period of intravenous anticoagulation provides little benefit over immediate ED discharge.”

Peacock et al. noted their study had a smaller than expected sample size due to slow enrollment and an unexpected funding decrease. The trial was sponsored by Janssen Pharmaceuticals, which manufactures rivaroxaban (brand name: Xarelto).