New data from the MERCURY PE study have shown that patients with low-risk pulmonary embolism who were treated with the direct oral anticoagulant rivaroxaban, trade name Xarelto (Janssen Pharmaceutical), and discharged from the emergency department had significantly reduced time in the hospital and a median savings of US$2,496 in per-patient costs, compared to standard of care in-patient treatment.
Results from MERCURY PE, which evaluated the benefits of treating patients with low-risk pulmonary embolism with Xarelto and discharging them early from the emergency department to complete treatment at home, were published in Academic Emergency Medicine.
“Every year, US health care systems spend more than two billion dollars to manage patients with pulmonary emboli,” said principal study investigator W Frank Peacock, associate chair and research director, Emergency Medicine, Baylor College of Medicine, Houston, USA. “By avoiding hospitalisations that are not clinically necessary and transitioning patients with low-risk pulmonary embolism to out-patient treatment with Xarelto, we have seen significant cost savings, which could help alleviate the burden on health care systems.”
Venous thromboembolism (VTE) includes deep vein thrombosis (DVT) and pulmonary embolism. Of the approximately 900,000 Americans who experience a VTE each year, more than 250,000 are diagnosed with pulmonary embolism in the emergency department. Hospitals across the USA have varying protocols for managing pulmonary embolism, but standard of care typically requires people to be admitted for treatment, which drives up costs and substantially increases hospital-acquired conditions and infections. While people with more severe pulmonary embolism have higher mortality rates, the 30-day mortality rate in low-risk patients is less than 1%.
MERCURY PE met its primary efficacy endpoint, with Xarelto leading to significantly reduced time in the hospital due to VTE or bleeding within 30 days after randomisation compared with the standard of care (mean duration of 4.8 vs. 33.6 hours, respectively; 95% CI; p<0.0001). The mean difference of length of stay between the two groups was 28.8 hours. Of note, there was no recurrence of VTE or VTE-related death or any significant differences in the bleeding-related hospitalisations or physician visits within 90 days from randomisation in either group, though this outcome should be interpreted with caution, as the study was significantly underpowered to detect any such differences.
Patients with low-risk pulmonary embolism were randomly assigned in a 1:1 ratio to open label Xarelto or standard of care within 12 hours of diagnosis. Patients randomised to the direct oral anticoagulant were discharged from the emergency department within 24 hours and were instructed to take a 15mg dose, twice daily for 21 days, then 20mg once daily until the study was completed. Patients randomised to standard of care were treated per local hospital protocol, which could include hospitalisation and any US Food and Drug Administration-approved anticoagulant strategy, including Xarelto.
Researchers also made the following observations about the anticoagulant drug in this setting:
- The mean length of initial and subsequent hospitalisations for any reason was shorter for patients who were discharged early on Xarelto within 90 days from randomisation compared to those receiving standard of care (p=0.024; 19.2 hours vs. 43.2 hours, respectively).
- There was no major bleeding in either group within 90 days from randomisation, although two patients reported clinically relevant non-major bleeding, one in each group. There were no deaths due to bleeding in the study.
- Overall, early discharge on the direct oral anticoagulant was markedly less expensive than standard of care. The cost associated with the emergency room visit and any subsequent hospitalisation at the time of diagnosis and the total costs were US$2,638 (p<0.001) and US$2,496 (p<0.001) less compared to standard of care.
MERCURY PE builds on prior research, including a June 2015 study published in Academic Emergency Medicine showing that 106 patients with low-risk pulmonary embolism or DVT, when prescribed Xarelto and immediately discharged, had no recurrent events while on therapy. Additionally, no major or clinically relevant bleeding events were observed. A companion study found patients with low-risk pulmonary embolism or DVT who were prescribed Xarelto had significantly lower medical costs than those admitted and given standard treatment.
The clinical and economic benefits demonstrated in the MERCURY-PE trial have been confirmed in more than 3,100 US patients in a real-world study, showing that the anticoagulant resulted in a significant one-day reduction in hospital length of stay and significantly lower total healthcare costs (approximately US$2,000).